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ONSD According to the Position During Laparoscopy (ONSD)

Primary Purpose

Cholecystitis, Ovarian Cyst, Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Desflurane
Remifentanil
Ultrasonographic measurement of ONSD
Mechanical ventilation
Trendelenburg position - 30 degree
Reverse Trendelenburg position - 30 degree
Sponsored by
Chosun University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cholecystitis focused on measuring Intracranial pressure, Laparoscopy, Optic nerve sheath diameter, Position

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients who are scheduled to undergo laparoscopic surgery, American society of anesthesiologist class (ASA) I-II, aged between 19 to 65 years

Exclusion Criteria:

  • Aged unger 18 years or over 65 years
  • American society of anesthesiologist class (ASA) III-IV
  • Patients with increased intracranial pressure (e.g. hydrocephalus, intracranial hemorrhage, etc.)
  • Patients with opthalmologic disease

Sites / Locations

  • Chosun University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust minimum alveolar concentration (MAC) to maintain bispectral index (BIS) between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Trendelenburg position - 30 degree

Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust MAC to maintain BIS between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Reverse Trendelenburg position - 30 degree

Outcomes

Primary Outcome Measures

ONSD and PaCO2
ONSD and PaCO2 - 5 minutes after introducing positional change

Secondary Outcome Measures

ONSD and PaCO2
ONSD and PaCO2 - 5 minutes after introducing pneumoperitoneum

Full Information

First Posted
September 4, 2013
Last Updated
October 28, 2014
Sponsor
Chosun University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01937104
Brief Title
ONSD According to the Position During Laparoscopy
Acronym
ONSD
Official Title
Comparison of Optic Nerve Sheath Diameter According to Position During Laparoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chosun University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Increase of intracerebral pressure (ICP) during laparoscopic surgery has known to be associated with positional changes. Optic nerve sheath diameter (ONSD) has correlation with ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to investigate the change of ONSD according to the positional change during laparoscopic surgery.
Detailed Description
Purpose There can be many physiologic changes during laparoscopic surgery. Increase of intracerebral pressure (ICP) is one of them, which has known to be associated with arterial concentration of carbon dioxide or positional changes. Changes of ICP can be measured directly by invasive method. However, optic nerve sheath diameter (ONSD) has correlation with ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to investigate the change of ONSD according to the positional change during laparoscopic surgery. Hypothesis Changes of ONSD will be shown according to the positional change during laparoscopic surgery, and these can reflect the changes of ICP. Objectives Female patients who are scheduled to undergo laparoscopic surgery, American society of anesthesiologist class (ASA) I-II, aged between 19 to 65 years, are allocated into 2 groups. Group 1: Laparoscopic gynecological surgery, (Trendelenburg position) Group 2: Laparoscopic cholecystectomy, (Reverse trendelenburg position) Methods Patients are premedicated with midazolam 0.5 mg/kg before transported to the operating room. Once in the operating room, patients were monitored with electrocardiography, non invasive blood pressure, pulse oximetry (Datex-Ohmeda S/5, Planar Systems, Inc., Beaverton, OR, USA) and BIS (Aspect 2000, Aspect Medical Systems, Inc., Newton, MA, USA). Anesthesia are induced with propofol (2mg/kg) and followed by administering rocuronium 0.6 mg/kg. After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:2) using a tidal volume of 8-10 mL/kg and a respiratory rate of 10-12/min, and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Anesthesia is maintained with desflurane in addition to the continuous infusion of remifentanil. Radial arterial cannulation is done for invasive arterial blood pressure monitoring. After induction of anesthesia, when stabilization of cardiovascular status is achieved, optic nerve sheath diameter (ONSD) is measured by ultrasonographic measurement. Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area (4 cm deep) using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values. ONSD was measured at 7 serial time points during surgery: Preinduction (prior to the induction of anesthesia in the operating room) 5 minutes after induction of anesthesia 5 minutes after introducing pneumoperitoneum 5 minutes after positional change 15 minutes after positional change 30 minutes after positional change 5 minutes after discontinuing pneumoperitoneum Arterial blood gas analysis is performed to evaluate the arterial carbon dioxide concentration (PaCO2) level at each time point. Statistical Analysis All data are expressed as numbers (%) or mean ± standard deviation. Repeated measures ANOVA will be performed to compare the parameters at specific time points during surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Ovarian Cyst, Ovarian Cancer, Uterine Myoma, Cervical Cancer
Keywords
Intracranial pressure, Laparoscopy, Optic nerve sheath diameter, Position

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust minimum alveolar concentration (MAC) to maintain bispectral index (BIS) between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Trendelenburg position - 30 degree
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust MAC to maintain BIS between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Reverse Trendelenburg position - 30 degree
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Anesthesia with desflurane in both Group 1 and Group 2 - adjust MAC to maintain BIS between 40-60
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20%
Intervention Type
Device
Intervention Name(s)
Ultrasonographic measurement of ONSD
Intervention Description
Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area (4 cm deep) using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values.
Intervention Type
Procedure
Intervention Name(s)
Mechanical ventilation
Intervention Description
After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:2) using a tidal volume of 8-10 mL/kg and a respiratory rate of 10-12/min, and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O.
Intervention Type
Procedure
Intervention Name(s)
Trendelenburg position - 30 degree
Intervention Description
Trendelenburg position - 30 degree
Intervention Type
Procedure
Intervention Name(s)
Reverse Trendelenburg position - 30 degree
Intervention Description
Reverse Trendelenburg position - 30 degree
Primary Outcome Measure Information:
Title
ONSD and PaCO2
Description
ONSD and PaCO2 - 5 minutes after introducing positional change
Time Frame
5 minutes after introducing positional change
Secondary Outcome Measure Information:
Title
ONSD and PaCO2
Description
ONSD and PaCO2 - 5 minutes after introducing pneumoperitoneum
Time Frame
5 minutes after introducing pneumoperitoneum
Other Pre-specified Outcome Measures:
Title
Preinduction ONSD
Description
ONSD - preinduction (prior to the induction of anesthesia in the operating room)
Time Frame
prior to the induction of anesthesia, an expected average of 5 minutes
Title
ONSD and PaCO2
Description
ONSD and PaCO2 - 5 minutes after induction of anesthesia
Time Frame
5 minutes after induction of anesthesia
Title
ONSD and PaCO2
Description
ONSD and PaCO2 - 15 min after positional change
Time Frame
15 minutes after positional change
Title
ONSD and PaCO2
Description
ONSD and PaCO2 - 30 minutes after positional change
Time Frame
30 minutes after positional change
Title
ONSD and PaCO2
Description
ONSD and PaCO2 - 5 minutes after discontinuing pneumoperitoneum
Time Frame
5 minutes after discontinuing pneumoperitoneum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients who are scheduled to undergo laparoscopic surgery, American society of anesthesiologist class (ASA) I-II, aged between 19 to 65 years Exclusion Criteria: Aged unger 18 years or over 65 years American society of anesthesiologist class (ASA) III-IV Patients with increased intracranial pressure (e.g. hydrocephalus, intracranial hemorrhage, etc.) Patients with opthalmologic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Tae Jung, M.D.
Organizational Affiliation
Department of Anesthesiology and Pain medicine School of Medicine, Chosun University
Official's Role
Study Chair
Facility Information:
Facility Name
Chosun University Hospital
City
Gwangju
State/Province
Donggu
ZIP/Postal Code
501-717
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16517337
Citation
Gerges FJ, Kanazi GE, Jabbour-Khoury SI. Anesthesia for laparoscopy: a review. J Clin Anesth. 2006 Feb;18(1):67-78. doi: 10.1016/j.jclinane.2005.01.013.
Results Reference
result
PubMed Identifier
21463263
Citation
Moretti R, Pizzi B. Ultrasonography of the optic nerve in neurocritically ill patients. Acta Anaesthesiol Scand. 2011 Jul;55(6):644-52. doi: 10.1111/j.1399-6576.2011.02432.x. Epub 2011 Apr 4.
Results Reference
result
PubMed Identifier
18786243
Citation
Geeraerts T, Newcombe VF, Coles JP, Abate MG, Perkes IE, Hutchinson PJ, Outtrim JG, Chatfield DA, Menon DK. Use of T2-weighted magnetic resonance imaging of the optic nerve sheath to detect raised intracranial pressure. Crit Care. 2008;12(5):R114. doi: 10.1186/cc7006. Epub 2008 Sep 11.
Results Reference
result
PubMed Identifier
19636971
Citation
Moretti R, Pizzi B, Cassini F, Vivaldi N. Reliability of optic nerve ultrasound for the evaluation of patients with spontaneous intracranial hemorrhage. Neurocrit Care. 2009 Dec;11(3):406-10. doi: 10.1007/s12028-009-9250-8.
Results Reference
result
PubMed Identifier
17668184
Citation
Geeraerts T, Launey Y, Martin L, Pottecher J, Vigue B, Duranteau J, Benhamou D. Ultrasonography of the optic nerve sheath may be useful for detecting raised intracranial pressure after severe brain injury. Intensive Care Med. 2007 Oct;33(10):1704-11. doi: 10.1007/s00134-007-0797-6. Epub 2007 Aug 1.
Results Reference
result

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ONSD According to the Position During Laparoscopy

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