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Anesthetics and Cerebral Oxygenation in LSG

Primary Purpose

Morbid Obesity, Bariatric Surgery Candidate, Anesthesia

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Inhalational anesthetic
Intravenous anesthetic
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Morbid Obesity focused on measuring Bariatric, Surgery, Sevoflurane, Propofol, Oximetry

Eligibility Criteria

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

Inclusion Criteria:

  • The American Society of Anaesthesiologists (ASA) physical status class II-III
  • BMI of ≥ 35 kg/m2
  • Patients were planning on undergoing an elective laparoscopic sleeve gastrectomy (LSG)

Exclusion Criteria:

  • Patients with preexisting cerebrovascular diseases, overt neurological signs, alcohol or psychoactive drug addiction
  • Uncontrolled diabetes or hypertension
  • Advanced organ failure
  • Preoperative peripheral oxygen saturation (SpO2) less than 96%
  • 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

The Inhalation Group

The TIVA (total intravenous anesthesia) Group

Arm Description

Sevoflurane (1 minimum alveolar concentration [MAC]) were used in the Inhalation group for the maintenance of anesthesia.

Propofol infusion (4-8 mg/kg of total body weight/h) were used in the TIVA group.

Outcomes

Primary Outcome Measures

Cerebral oxygen saturation
The rSO2 values of the patients were recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit. Measurements in the last 30 seconds of preoxygenation, performed for three minutes with 4 L/min oxygen (80%) pre-induction, were accepted as preoperative values.Cerebral oxygen desaturation was defined as a greater than 25% decrease in the rSO2 value compared to the preoperative value (decrease should be more than 20% if the preoperative value is <50) and maintenance of this situation for ≥15 seconds. In this case, the following algorithm was used. First of all, normotension of the patient was ensured (administration of vasopressors such as ephedrine, and/or infusion of isotonic fluids) and the patient's neck was checked. External factors causing arterial or venous obstruction were restored, if any. If no recovery was seen despite these steps, FiO2 was set at 100%.
Arterial Blood Gas (ABG) analysis-pH
The pH values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.
Arterial Blood Gas (ABG) analysis-Partial pressure of carbon dioxide
The partial pressure of carbon dioxide values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.
Arterial Blood Gas (ABG) analysis-Hemoglobin
The hemoglobin values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.

Secondary Outcome Measures

The heart rate (HR) measurement
The heart rate was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit. HR values were allowed to fluctuate up to 20% of the preoperative values of the patients. For this purpose, the infusion rate of remifentanil was accordingly increased and decreased. Whenbradycardia (HR <45 beats/minute) continued for longer than three minutes, they were treated with IV 0.5 mg atropine.
The oxygen saturation measurement
The oxygen saturation was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.
The mean arterial pressure measurement
The mean arterial pressure was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.
The end-tidal carbon dioxide partial pressure measurement
The end-tidal carbon dioxide partial pressure was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit.
The anesthesia time (min)
The anesthesia time was defined as the length of time the patient was anesthetized.
The reverse-Trendelenburg time (min)
The reverse-Trendelenburg time was defined as the length of time the patient was in the reverse-Trendelenburg position.
The pneumoperitoneum time (min)
The pneumoperitoneum time was defined as the length of time the patient had pneumoperitoneum
The recovery time (min)
The recovery time was defined as the time from discontinuation of sevoflurane or propofol and remifentanil at the end of the surgery to the restoration of spontaneous breathing, opening of the eyes upon a verbal command, squeezing of the hand of the observer and extubation.

Full Information

First Posted
May 7, 2019
Last Updated
July 21, 2020
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT03946657
Brief Title
Anesthetics and Cerebral Oxygenation in LSG
Official Title
A Comparison of Cerebral Oximetry After Propofol-Based Total Intravenous Anesthesia and Sevoflurane Inhalation Anesthesia in Morbidly Obese Patients Undergoing LSG: a Prospective, Single-Blinded, Randomized, Parallel-Group Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (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
Obesity is a global health issue that affects different organ systems and may cause severe health issues. Patients with a BMI > 40 kg/m2 or those with a BMI > 35 kg/m2 with accompanying comorbidities are candidates for weight loss surgeries, which are generally referred to as bariatric surgeries. Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric surgery procedure gaining increased popularity in the surgical treatment of morbid obesity. However, LSG requires a reverse-Trendelenburg position and prolonged pneumoperitoneum. Carbon dioxide pneumoperitoneum increases intracranial pressure (ICP) by increasing intra-abdominal pressure and by causing dilation of cerebral vessels through carbon dioxide reabsorption. Also, the reverse-Trendelenburg position decreases cardiac output and mean arterial pressure (MAP) by reducing cardiac venous return. A Near-infrared spectroscopy (NIRS) is a non-invasive technique and provides continuous monitoring of regional cerebral tissue oxygen saturation (rSO2). Sevoflurane and propofol are widely used for the maintenance of general anesthesia during bariatric surgery. Sevoflurane is an efficacious halogenated inhalational anesthetic for bariatric surgery because of its rapid and consistent recovery and because it does not cause hemodynamic instability because of its low blood solubility. Moreover, it increases global CBF through a direct intrinsic cerebral vasodilatory action and, in addition, it might improve cerebral oxygenation by decreasing the cerebral metabolic rate of oxygen (CMRO2) (luxury perfusion). Propofol can also be a suitable option for the maintenance of anesthesia in bariatric surgery. Propofol is a short-acting intravenous anesthetic agent with a very good recovery profile, and its elimination half-life and duration of action do not change in obese individuals. However, it has been reported that propofol may significantly decrease CBF by both suppressing CMRO2 and through a direct vasoconstrictive action. The impact of propofol on global CBF is more salient than that on CMRO2, resulting in a decrease in rSO2. The aim of the present study was to test the hypothesis that rSO2 is better preserved with sevoflurane than propofol in morbidly obese patients who have undergone LSG.
Detailed Description
All patients were administered 300 mg of oral ranitidine the night before the surgery and 10 mg intravenous (IV) metoclopramide in combination with 150 mg ranitidine one hour before arrival to the operating room. Upon the arrival to the operating room, an electrocardiogram, noninvasive blood pressure, SpO2, rSO2 (INVOSTM 5100C oximeter; Covidien, Massachusetts, USA) and neuromuscular monitorization (TOF-WatchTM SX, Organon, Dublin, Ireland) were performed on the patients. Afterwards, preoxygenation was performed with 4 L/min oxygen (80%) for three minutes by using facemasks, and anesthesia was induced with an IV propofol injection (1.5-2.5 mg/kg of ideal body weight) and an IV bolus administration of remifentanil [1 mcg/kg of lean body weight (LBW)] for 30-60 s, and then switched to infusion at 0.25 mcg/kg of LBW/min. After the eyelid reflex disappeared, a neuromuscular blockade was performed using rocuronium (1.2 mg/kg of LBW), ensuring that the train-of-four count and the post-tetanic count (PTC) were both zero, and performed tracheal intubation. Mechanical ventilation was performed with a Draeger FabiusTM Plus anesthesia workstation (Draeger Medical, Lübeck, Germany), and volume-controlled mechanical ventilation was applied. Breathing gases (oxygen, carbon dioxide, sevoflurane) were measured using Draeger ScioTM gas measurement module (Draeger Medical, Lübeck, Germany). The tidal volume was set as 7-8 mL/kg of LBW, inspiratory: expiratory ratio as 1:2, positive end-expiratory pressure as 5-8 cmH2O, and the respiratory rate was determined to obtain an end-tidal carbon dioxide partial pressure (PETCO2) of 32-37 mmHg. These ventilator settings were not changed throughout the operation. Furthermore, after the induction of anesthesia, a radial arterial line was placed in all patients for the continuous measurement of mean arterial pressure and intermittent arterial blood gas analysis. Oxygen/air (fraction of inspired oxygen (FiO2) of 0.40), inspiratory fresh gas flow of 2 L/min), sevoflurane (1 minimum alveolar concentration [MAC]) and remifentanil IV infusion (0.1-0.25 mcg/kg of LBW/min) were used in the Inhalation group for the maintenance of anesthesia. Propofol infusion (4-8 mg/kg of total body weight/h), oxygen/air (FiO2 of 0.40; inspiratory fresh gas flow of 2 L/min) and remifentanil IV infusion (0.1-0.25 μg/kg of LBW/min) were used in the TIVA group. Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero. IV normal saline or lactated Ringer's solution at 5-7 mL/kg of LBW was also used for perioperative fluid maintenance. Nasopharyngeal temperature was monitored throughout the surgery, and the patient temperature (36-37°C) was ensured by using a forced-air warming system for the maintenance of intraoperative normothermia during the procedure. After anesthesia induction, a neutral head position of the patients was preserved to prevent alteration of cerebral venous drainage. Carbon dioxide insufflation was performed with an electronic laparoflator using a closed Veress needle technique, and intra-abdominal pressure was automatically kept at the desired level (14-16 mmHg) during the surgery. After the insufflation of carbon dioxide, the patients were positioned in a 30° reverse-Trendelenburg and at a 10° right lateral position. At the end of the surgery, the blockade was reversed by administering 4 mg/kg of adjusted body weight sugammadex with a PTC of 1-2. All patients were extubated in the beach chair position when fully awake. The patients were referred to the recovery unit and monitored for 50 minutes for complications. In cases where no complications were apparent, the recovery was evaluated using the modified Aldrete scoring system. Once the score was ≥9, the patients were taken to unit. For postoperative nausea and vomiting, 4-5 mg dexamethasone was used (except for diabetic patients on insulin) 90 min before anesthesia induction and 4-8 mg IV ondansetron 20-30 min before the end of the operation. For postoperative pain management, 1 g IV acetaminophen was administered 20 min after induction and 30 mg IV ketorolac 20 min before onset. Then, 1 g IV acetaminophen was administered every 6 h + 50 mg IV dexketoprofen every 8 h for the first 48 hours. In addition, morphine was administered using a patient-controlled analgesia delivery system (demand dose, 20 µg/kg of ideal body weight; lockout time, 6-10 min; 4 h limit, 80% of the total calculated dosage) for 48 h postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Bariatric Surgery Candidate, Anesthesia
Keywords
Bariatric, Surgery, Sevoflurane, Propofol, Oximetry

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
For the investigation, the patients were randomly assigned to two groups; the Inhalation group including those who received sevoflurane-remifentanil for the maintenance of anesthesia (n = 30) and the TIVA (total intravenous anesthesia) group including those who had propofol-remifentanil infusion for the maintenance of anesthesia (n = 30). The anesthesiologist caring for the patient was aware of the group assignments. The patients were blinded to the group assignments.
Masking
Participant
Masking Description
The patients were randomly assigned using opaque sealed envelopes to two groups; the Inhalation group including those who received sevoflurane-remifentanil for the maintenance of anesthesia (n = 30) and the TIVA (total intravenous anesthesia) group including those who had propofol-remifentanil infusion for the maintenance of anesthesia (n = 30). Randomization was performed according to a computer-generated randomization code, and a statement showing the patients' group was placed in sealed, numbered enveloped according to the results. Each patient drew an envelope and was enrolled in the study depending on the group written in the envelope. Randomization was performed by a physician who was not involved in the monitorization of the patients.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Inhalation Group
Arm Type
Active Comparator
Arm Description
Sevoflurane (1 minimum alveolar concentration [MAC]) were used in the Inhalation group for the maintenance of anesthesia.
Arm Title
The TIVA (total intravenous anesthesia) Group
Arm Type
Active Comparator
Arm Description
Propofol infusion (4-8 mg/kg of total body weight/h) were used in the TIVA group.
Intervention Type
Drug
Intervention Name(s)
Inhalational anesthetic
Intervention Description
Oxygen/air (fraction of inspired oxygen (FiO2) of 0.40), inspiratory fresh gas flow of 2 L/min), sevoflurane (1 minimum alveolar concentration [MAC]) and remifentanil IV infusion (0.1-0.25 mcg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.
Intervention Type
Drug
Intervention Name(s)
Intravenous anesthetic
Intervention Description
Propofol infusion (4-8 mg/kg of total body weight/h), oxygen/air (FiO2 of 0.40; inspiratory fresh gas flow of 2 L/min) and remifentanil IV infusion (0.1-0.25 μg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.
Primary Outcome Measure Information:
Title
Cerebral oxygen saturation
Description
The rSO2 values of the patients were recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit. Measurements in the last 30 seconds of preoxygenation, performed for three minutes with 4 L/min oxygen (80%) pre-induction, were accepted as preoperative values.Cerebral oxygen desaturation was defined as a greater than 25% decrease in the rSO2 value compared to the preoperative value (decrease should be more than 20% if the preoperative value is <50) and maintenance of this situation for ≥15 seconds. In this case, the following algorithm was used. First of all, normotension of the patient was ensured (administration of vasopressors such as ephedrine, and/or infusion of isotonic fluids) and the patient's neck was checked. External factors causing arterial or venous obstruction were restored, if any. If no recovery was seen despite these steps, FiO2 was set at 100%.
Time Frame
The rSO2 values of the patients were recorded from baseline untill 20 minutes after the extubation, up to 120 min.
Title
Arterial Blood Gas (ABG) analysis-pH
Description
The pH values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.
Time Frame
The pH values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min.
Title
Arterial Blood Gas (ABG) analysis-Partial pressure of carbon dioxide
Description
The partial pressure of carbon dioxide values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.
Time Frame
The partial pressure of carbon dioxide values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min.
Title
Arterial Blood Gas (ABG) analysis-Hemoglobin
Description
The hemoglobin values of the patients were measured in the fifth minute post-induction with the patient in the neutral position, in the 30th minute post-insufflation in the reverse-Trendelenburg position of patient and post-extubation right before the patient was referred to the recovery unit.
Time Frame
The hemoglobin values of the patients were recorded after anesthesia induction until the patient was referred to the recovery unit, up to 120 min.
Secondary Outcome Measure Information:
Title
The heart rate (HR) measurement
Description
The heart rate was recorded preoperatively, one minute after the induction, and every five minutes until the patient was referred to the recovery unit. HR values were allowed to fluctuate up to 20% of the preoperative values of the patients. For this purpose, the infusion rate of remifentanil was accordingly increased and decreased. Whenbradycardia (HR <45 beats/minute) continued for longer than three minutes, they were treated with IV 0.5 mg atropine.
Time Frame
The heart rate was recorded from baseline until the patient was referred to the recovery unit, up to 120 min.
Title
The oxygen saturation measurement
Description
The oxygen saturation was recorded preoperatively, one minute after the induction, and every five 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 120 min.
Title
The mean arterial pressure measurement
Description
The mean arterial pressure was recorded preoperatively, one minute after the induction, and every five 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 120 min.
Title
The end-tidal carbon dioxide partial pressure measurement
Description
The end-tidal carbon dioxide partial pressure was recorded preoperatively, one minute after the induction, and every five 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 120 min.
Title
The anesthesia time (min)
Description
The anesthesia time was defined as the length of time the patient was anesthetized.
Time Frame
The anesthesia time was recorded through study completion.
Title
The reverse-Trendelenburg time (min)
Description
The reverse-Trendelenburg time was defined as the length of time the patient was in the reverse-Trendelenburg position.
Time Frame
The reverse-Trendelenburg time was recorded through study completion.
Title
The pneumoperitoneum time (min)
Description
The pneumoperitoneum time was defined as the length of time the patient had pneumoperitoneum
Time Frame
The pneumoperitoneum time was recorded through study completion.
Title
The recovery time (min)
Description
The recovery time was defined as the time from discontinuation of sevoflurane or propofol and remifentanil at the end of the surgery to the restoration of spontaneous breathing, opening of the eyes upon a verbal command, squeezing of the hand of the observer and extubation.
Time Frame
The recovery time was recorded at the end of the surgery untill the 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: The American Society of Anaesthesiologists (ASA) physical status class II-III BMI of ≥ 35 kg/m2 Patients were planning on undergoing an elective laparoscopic sleeve gastrectomy (LSG) Exclusion Criteria: Patients with preexisting cerebrovascular diseases, overt neurological signs, alcohol or psychoactive drug addiction Uncontrolled diabetes or hypertension Advanced organ failure Preoperative peripheral oxygen saturation (SpO2) less than 96% Hemoglobin <9 g/dL .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CENGIZ KAYA, Assoc. Prof.
Organizational Affiliation
Ondokuz Mayis University, School of Medicine, Department of Anesthesiology
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
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Anesthetics and Cerebral Oxygenation in LSG

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