The Effect of Pnemoperitoneum on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Surgery According to Anesthesia Agents: Propofol Based Total Intravenous Anesthesia vs Desflurane Anesthesia

July 13, 2014 updated by: Yonsei University
The pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. The aim of this study is to compare the effect of pnemoperitoneum on intracranial pressure and cerebral oxygenation during laparoscopic surgery according to anesthesia agents, propofol based total intravenous anesthesia (TIVA group) and desflurane anesthesia (Des group).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (20-80 years of age) scheduled for laparoscopic cholecystectomy undergoing general anesthesia

Exclusion Criteria:

  • Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TIVA
2% Propofol (Fresofol®), Remifentanil 20mcg/cc (Ultiva®)
Drug: Propofol
80 patients are randomly allocated into two groups: In TIVA group, propofol based total intravenous anesthesia is used to induce and maintain anesthesia for laparoscopic cholescystectomy.
ACTIVE_COMPARATOR: Des
Desflurane (Suprane®), Remifentanil continuous infusion (20mcg/cc)
Drug: Desflurane
80 patients are randomly allocated into two groups : In Des group, inhalation anesthesia using desflurane is used to induce and maintain anesthesia for laparoscopic cholescystectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the ultrasonographic measurement of optic nerve sheath diameter
Time Frame: baseline
optic nerve sheath diameter measured by ultrasonography
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2015

Study Completion (ANTICIPATED)

October 1, 2015

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (ESTIMATE)

December 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 13, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0626

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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