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
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interventional
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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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2013
Typical duration for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 2, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJuly 15, 2014
July 1, 2014
1.7 years
December 2, 2013
July 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the ultrasonographic measurement of optic nerve sheath diameter
optic nerve sheath diameter measured by ultrasonography
baseline
Study Arms (2)
TIVA
EXPERIMENTAL2% Propofol (Fresofol®), Remifentanil 20mcg/cc (Ultiva®)
Des
ACTIVE COMPARATORDesflurane (Suprane®), Remifentanil continuous infusion (20mcg/cc)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adult patients (20-80 years of age) scheduled for laparoscopic cholecystectomy undergoing general anesthesia
You may not qualify if:
- Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.
PMID: 22258019BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2013
First Posted
December 6, 2013
Study Start
October 1, 2013
Primary Completion
June 1, 2015
Study Completion
October 1, 2015
Last Updated
July 15, 2014
Record last verified: 2014-07