COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02003768
Recruitment Status : Withdrawn
First Posted : December 6, 2013
Last Update Posted : July 15, 2014
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Optic Nerve Sheath Drug: Propofol Drug: Desflurane Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : October 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. the ultrasonographic measurement of optic nerve sheath diameter [ Time Frame: baseline ]
    optic nerve sheath diameter measured by ultrasonography

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Layout table for additonal information
Responsible Party: Yonsei University Identifier: NCT02003768    
Other Study ID Numbers: 4-2013-0626
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014
Keywords provided by Yonsei University:
optic nerve sheath diameter
general anesthesia
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation