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Pneumoperitoneum and Cerebral Oxygenation

Primary Purpose

Laparoscopic Nephrectomy, Cerebral Oxygen Saturation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Standart pressure pneumoperitoneum
Low pressure pneumoperitoneum
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Laparoscopic Nephrectomy focused on measuring Pneumoperitoneum, Spectroscopy, Near-infrared, Oximetry, Brain, Nephrectomy, Surgery, Laparoscopic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for laparoscopic nephrectomy (simple, partial, or radical)
  • The American Society of Anesthesiologists (ASA) physical status class I-III

Exclusion Criteria:

  • Cerebrovascular diseases
  • Neurological disorders
  • Uncontrolled diabetes or hypertension
  • Advanced organ failure
  • Baseline peripheral oxygen saturation (SpO2) less than 96%
  • Patients with hemoglobin <9 g/dL

Sites / Locations

  • Ondokuz Mayis Universitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Grup LP (n = 31)

Grup SP (n = 31)

Arm Description

CO2 insufflation pressure was kept at 8 mmHg throughout the surgery.

CO2 insufflation pressure was kept at 14 mmHg throughout the surgery.

Outcomes

Primary Outcome Measures

Regional cerebral oxygen saturation (rSO2)
The rSO2 measurements were made using the near-infrared spectroscopy (NIRS) method. For this, prior to induction, the cerebral oximetry sensor was placed at least 2 cm above the eyebrows and 3 cm from the midline in accordance with the manufacturer's instructions. Measurements were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient went to the recovery unit. Baseline values were accepted as measurements in the last 30 seconds of preoxygenation for 3 minutes with 80% oxygen before induction. Cerebral desaturation was defined as a decrease in the rSO2 value of more than 25% from the baseline value (if the baseline value is <50, the decrease should be more than 20%), with this condition lasting ≥15 seconds.
Arterial Blood Gas (ABG) analysis-pH
The pH value was measured in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position.
Arterial blood gas analysis: partial pressure of oxygen (PO2)
The PO2 value was measured in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position.
Arterial blood gas analysis: partial pressure of carbon dioxide (PCO2)
The PCO2 value was measured in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position.
Arterial blood gas analysis: Hemoglobin (Hg) value
The Hg value was measured in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position.

Secondary Outcome Measures

The mean arterial pressure (MAP) values
The data of the mean arterial pressure were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit.
The heart rate (HR) values
The data of heart rate were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit. The MAP and HR values were kept at ±20% of the preoperative values by changing the remifentanil infusion rate. Hypotension MAP was defined as <60 mmHg and bradycardia HR as 45 beats/minute, and were treated with noradrenaline 4-8 mcg and atropine 0.5 mg. Patients who required noradrenaline or atropine more than twice were excluded from the study.
Peripheral oxygen saturation (SPO2) values
The SPO2 data were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit.
Anesthesia time (min)
The duration of anesthesia was defined as the time the patient was under anesthesia.
Surgical Time (min)
Surgical time was defined as the time elapsed from the time the trocar insertion was completed until the surgery was completed and the trocars were removed.
Pneumoperitoneum Time (min)
This was defined as the time during which pneumoperitoneum was administered to the patient.
End-tidal carbon dioxide values (EtCO2) values
The data for EtCO2 were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit.
Lateral Semi-oblique Position Time (min)
This was defined as the time the patient stayed in the lateral semi-oblique position.
Recovery Time (min)
The recovery time was defined as the time from discontinuation of sevoflurane and remifentanil to extubation at the end of the surgical procedure.

Full Information

First Posted
December 10, 2020
Last Updated
December 16, 2020
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT04671121
Brief Title
Pneumoperitoneum and Cerebral Oxygenation
Official Title
An Analysis of Cerebral Oximetry After Low Pressure Compared With Standard Pressure Pneumoperitoneum in Patients Undergoing Laparoscopic Nephrectomy: A Prospective Randomized Parallel-Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, the changes in cerebral oxygen saturation due to low and high pressure pneumoperitoneum implementation were measured in patients who underwent laparoscopic nephrectomy. This prospective, double-blind study included 62 American Society of Anesthesiologists (ASA) PS class I-III patients aged 18-65 years who underwent laparoscopic nephrectomy (simple, partial, or radical). Patients were randomly classified into 2 groups: Group LP (n = 31) included patients who were treated with low pressure pneumoperitoneum (8 mmHg) and Group SP (n = 31) included patients who were treated with standard pressure (14 mmHg). A standard anesthesia protocol was used in both groups. Bilateral rSO2 values were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient went to the recovery unit. Data for mean arterial pressure (MAP), peak heart rate (HR), peripheral oxgen saturation (SpO2), and end-tidal carbon dioxide (ETCO2) were also recorded at the same time intervals. Arterial blood gas was analyzed in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position. Patient demographic data, duration of anesthesia, duration of surgery, lateral position time, pneumoperitoneum time, and recovery time were also recorded. used in both groups. Bilateral rSO2 values were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient went to the recovery unit. Data for mean arterial pressure (MAP), peak heart rate (HR), SpO2, and ETCO2 were also recorded at the same time intervals. Arterial blood gas was analyzed in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position. Patient demographic data, duration of anesthesia, duration of surgery, lateral position time, pneumoperitoneum time, and recovery time were also recorded.
Detailed Description
A total of 62 American Society of Anesthesiologists (ASA) PS class I-III patients between the ages of 18 and 65 years who were scheduled for elective laparoscopic nephrectomy (simple, partial, or radical) were included in the study. A standard anesthesia protocol was used in both groups. Patients did not receive any sedative premedication. Upon entering the operating room, they underwent electrocardiogram, non-invasive blood pressure, peripheral oxygen saturation (SpO2), rSO2 (INVOS TM 5100C oximeter; Covidien), and neuromuscular monitoring (TOF-WatchTM SX; Organon, Dublin, Ireland). Subsequently, anesthesia was induced with propofol (1.5-2.5 mg/kg) and remifentanil (1 mcg/kg IV bolus for 30-60 seconds, then 0.25 mcg/kg/min), and rocuronium (1.2 mg/kg). Anesthesia was maintained with O2/Air (fraction of inspired oxygen of 0.40; inspiratory fresh gas flow of 2 L/min), sevoflurane (1 minimum alveolar concentration), and remifentanil IV infusion (0.1-0.25 mcg/kg/min). Radial arterial cannulation was also applied for arterial blood gas analysis and continuous blood pressure measurement. A mechanical ventilator (Draeger FabiusTM Plus anesthesia Workstation, Draeger Medical, Lübeck, Germany) was used at settings of tidal volume 7-8 mL/kg, inspirium/exprium expiratory ratio 1:2, and positive end-expiratory pressure of 5 cmH2O. With these settings, pre-insufflation Sp02 values were maintained at >96%, while the respiratory rate was determined with end-tidal CO2 (ETCO2) of 32-37 mmHg. These ventilator settings were maintained throughout the operation. CO2 insufflation was performed using the closed Veress needle technique with electronic laparoflators in the patients who were placed in lateral semi-oblique (60°) and some flexion (jackknife) positions before the surgery was started. Intra-abdominal pressure was maintained at 8 mmHg in Group LS and at 14 mmHg in Group SP throughout the surgery. During the operation, a neuromuscular blockade was achieved with rocuronium infusion (0.3-0.4 mg/kg/hour) with a post-tetanic count of zero. At the end of the case, extubation was provided by decurarizing the rocuronium with a combination of 0.02mg/kg atropine and 0.04 mg/kg neostigmine. All patients were followed up with nasopharyngeal temperature monitoring and were actively warmed using a forced-air warming system to ensure normothermia throughout the surgery. Patients were followed up in the recovery unit at the end of the surgery until their modified Aldrete score reached ≤9. Hemodynamics The data of mean arterial pressure (MAP), peak heart rate (HR), SpO2, and ETCO2 were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient went to the recovery unit. MAP and HR values were kept at ±20% of preoperative values by changing the remifentanil infusion rate. Hypotension MAP was defined as <60 mmHg and bradycardia HR as 45 beats/minute, and these were treated with noradrenaline 4-8 mcg, atropine 0.5 mg. Patients who required noradrenaline or atropine more than twice were excluded from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Nephrectomy, Cerebral Oxygen Saturation
Keywords
Pneumoperitoneum, Spectroscopy, Near-infrared, Oximetry, Brain, Nephrectomy, Surgery, Laparoscopic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients were randomly classified into 2 groups. The patients given the low-pressure pneumoperitoneum (8 mmHg) treatment were called Group LP (n = 30), and the patients given the standard pressure treatment (14 mmHg) were called Group SP (n = 30). Each patient and the anesthesiologist responsible for that patient's anesthesia management were blinded to the group assignments.
Masking
ParticipantCare Provider
Masking Description
Patients were randomly classified into 2 groups using opaque sealed envelopes. Randomization was performed using a computer-generated random number list, and a statement indicating the patient's group was placed in a closed envelope numbered according to the result. Each patient was asked to choose an envelope, and the patients were assigned to the study according to the group written in the envelope.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grup LP (n = 31)
Arm Type
Active Comparator
Arm Description
CO2 insufflation pressure was kept at 8 mmHg throughout the surgery.
Arm Title
Grup SP (n = 31)
Arm Type
Active Comparator
Arm Description
CO2 insufflation pressure was kept at 14 mmHg throughout the surgery.
Intervention Type
Procedure
Intervention Name(s)
Standart pressure pneumoperitoneum
Intervention Description
CO2 insufflation pressure was kept at 14 mmHg throughout the surgery.
Intervention Type
Procedure
Intervention Name(s)
Low pressure pneumoperitoneum
Intervention Description
CO2 insufflation pressure was kept at 8 mmHg throughout the surgery.
Primary Outcome Measure Information:
Title
Regional cerebral oxygen saturation (rSO2)
Description
The rSO2 measurements were made using the near-infrared spectroscopy (NIRS) method. For this, prior to induction, the cerebral oximetry sensor was placed at least 2 cm above the eyebrows and 3 cm from the midline in accordance with the manufacturer's instructions. Measurements were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient went to the recovery unit. Baseline values were accepted as measurements in the last 30 seconds of preoxygenation for 3 minutes with 80% oxygen before induction. Cerebral desaturation was defined as a decrease in the rSO2 value of more than 25% from the baseline value (if the baseline value is <50, the decrease should be more than 20%), with this condition lasting ≥15 seconds.
Time Frame
The rSO2 value changes were recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
Title
Arterial Blood Gas (ABG) analysis-pH
Description
The pH value was measured in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position.
Time Frame
The pH values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 minutes.
Title
Arterial blood gas analysis: partial pressure of oxygen (PO2)
Description
The PO2 value was measured in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position.
Time Frame
The oxygen partial pressure values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 minutes.
Title
Arterial blood gas analysis: partial pressure of carbon dioxide (PCO2)
Description
The PCO2 value was measured in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position.
Time Frame
The carbon dioxide partial pressure values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 minutes.
Title
Arterial blood gas analysis: Hemoglobin (Hg) value
Description
The Hg value was measured in the 5th minute after induction (t1) while the patient was in the supine position, in the 5th and 30th minutes after insufflation (t2, t3) while the patient was in the lateral semi-oblique position, and again 10 minutes after desufflation (t4) while the patient was in the supine position.
Time Frame
The hemoglobin values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 min.
Secondary Outcome Measure Information:
Title
The mean arterial pressure (MAP) values
Description
The data of the mean arterial pressure were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit.
Time Frame
The mean arterial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
Title
The heart rate (HR) values
Description
The data of heart rate were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit. The MAP and HR values were kept at ±20% of the preoperative values by changing the remifentanil infusion rate. Hypotension MAP was defined as <60 mmHg and bradycardia HR as 45 beats/minute, and were treated with noradrenaline 4-8 mcg and atropine 0.5 mg. Patients who required noradrenaline or atropine more than twice were excluded from the study.
Time Frame
The heart rate was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
Title
Peripheral oxygen saturation (SPO2) values
Description
The SPO2 data were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit.
Time Frame
The oxygen saturation was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
Title
Anesthesia time (min)
Description
The duration of anesthesia was defined as the time the patient was under anesthesia.
Time Frame
Anesthesia time was recorded during each operation.
Title
Surgical Time (min)
Description
Surgical time was defined as the time elapsed from the time the trocar insertion was completed until the surgery was completed and the trocars were removed.
Time Frame
Surgical time was recorded during each operation.
Title
Pneumoperitoneum Time (min)
Description
This was defined as the time during which pneumoperitoneum was administered to the patient.
Time Frame
The pneumoperitoneum time was recorded during each operation.
Title
End-tidal carbon dioxide values (EtCO2) values
Description
The data for EtCO2 were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit.
Time Frame
The end-tidal carbon dioxide partial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 160 min
Title
Lateral Semi-oblique Position Time (min)
Description
This was defined as the time the patient stayed in the lateral semi-oblique position.
Time Frame
The lateral semi-oblique position time was recorded during each operation.
Title
Recovery Time (min)
Description
The recovery time was defined as the time from discontinuation of sevoflurane and remifentanil to extubation at the end of the surgical procedure.
Time Frame
The recovery time was recorded from the end of the surgery to extubation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for laparoscopic nephrectomy (simple, partial, or radical) The American Society of Anesthesiologists (ASA) physical status class I-III Exclusion Criteria: Cerebrovascular diseases Neurological disorders Uncontrolled diabetes or hypertension Advanced organ failure Baseline peripheral oxygen saturation (SpO2) less than 96% Patients with hemoglobin <9 g/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cengiz Kaya
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ondokuz Mayis Universitesi
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55139
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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21170237
Citation
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26275545
Citation
Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.
Results Reference
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PubMed Identifier
11867365
Citation
de Waal EE, de Vries JW, Kruitwagen CL, Kalkman CJ. The effects of low-pressure carbon dioxide pneumoperitoneum on cerebral oxygenation and cerebral blood volume in children. Anesth Analg. 2002 Mar;94(3):500-5; table of contents. doi: 10.1097/00000539-200203000-00005.
Results Reference
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PubMed Identifier
27108820
Citation
Tuna AT, Akkoyun I, Darcin S, Palabiyik O. Effects of carbon dioxide insufflation on regional cerebral oxygenation during laparoscopic surgery in children: a prospective study. Braz J Anesthesiol. 2016 May-Jun;66(3):249-53. doi: 10.1016/j.bjane.2014.10.004. Epub 2015 May 12.
Results Reference
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PubMed Identifier
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Citation
Pelizzo G, Bernardi L, Carlini V, Pasqua N, Mencherini S, Maggio G, De Silvestri A, Bianchi L, Calcaterra V. Laparoscopy in children and its impact on brain oxygenation during routine inguinal hernia repair. J Minim Access Surg. 2017 Jan-Mar;13(1):51-56. doi: 10.4103/0972-9941.181800.
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PubMed Identifier
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Citation
Oztan MO, Aydin G, Cigsar EB, Sutas Bozkurt P, Koyluoglu G. Effects of Carbon Dioxide Insufflation and Trendelenburg Position on Brain Oxygenation During Laparoscopy in Children. Surg Laparosc Endosc Percutan Tech. 2019 Apr;29(2):90-94. doi: 10.1097/SLE.0000000000000593.
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Citation
Park EY, Koo BN, Min KT, Nam SH. The effect of pneumoperitoneum in the steep Trendelenburg position on cerebral oxygenation. Acta Anaesthesiol Scand. 2009 Aug;53(7):895-9. doi: 10.1111/j.1399-6576.2009.01991.x. Epub 2009 May 6.
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Citation
Nasrallah G, Souki FG. Perianesthetic Management of Laparoscopic Kidney Surgery. Curr Urol Rep. 2018 Jan 18;19(1):1. doi: 10.1007/s11934-018-0757-4.
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Pneumoperitoneum and Cerebral Oxygenation

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