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

NCT ID: NCT02003768

Last Updated: 2014-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Optic Nerve Sheath

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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TIVA

2% Propofol (Fresofol®), Remifentanil 20mcg/cc (Ultiva®)

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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.

Des

Desflurane (Suprane®), Remifentanil continuous infusion (20mcg/cc)

Group Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 22258019 (View on PubMed)

Other Identifiers

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4-2013-0626

Identifier Type: -

Identifier Source: org_study_id

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