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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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ClinicalTrials.gov Identifier: NCT02003768
Recruitment Status : Withdrawn
First Posted : December 6, 2013
Last Update Posted : July 15, 2014
Sponsor:
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

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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



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

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
Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov 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:
pneumoperitoneum
optic nerve sheath diameter
laparoscopy
Patients
general anesthesia
diameter
Additional relevant MeSH terms:
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Propofol
Desflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation