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

Optic Nerve Sheath Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02003768
• Other study ID #: 4-2013-0626
• Status: Withdrawn
• Phase: N/A
• First received: December 2, 2013
• Last updated: July 13, 2014
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: July 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board (Severance Hospital)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Optic Nerve Sheath

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the ultrasonographic measurement of optic nerve sheath diameter	optic nerve sheath diameter measured by ultrasonography	baseline	No