Mannitol Improves Cerebral Oxygen Saturation

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Control; Drug: Mannitol

• Registration Number: NCT02091180
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

Brief Summary

Decreased cerebral oxygen saturation (rSO2) was reported to occur during insufflation for laparoscopic procedures due to increased Intracranial pressure (ICP) with resultant decrease in cerebral perfusion pressure.

Detailed Description

Forty patients scheduled for laparoscopic cholecystectomy will be enrolled in this double blind, randomized controlled study. Patients will receive either 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia (group M) or an equal volume of 0.9% normal saline instead (group C). Primary outcome measure is rSO2. Secondary outcome variables include extubation time, clinical assessment of consciousness recovery using the modified Observer's assessment of alertness/sedation scale (OAA/S) and the mini-mental state examination (MMSE) for cognitive evaluation after recovery.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-11
• Study Completion: 2014-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-15
• Study First Submitted QC: 2014-03-18
• Last Update Submitted: 2014-03-18
• Study First Posted: 2014-03-19
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• American Society of Anesthesiologists physical status I or II
• aged between 25 and 50 years
• with a body mass index (BMI) 22-34 kg/m2

Exclusion Criteria

• obstructive or restrictive pulmonary disease
• cardiac dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Patients will receive normal saline
Mannitol	Mannitol	Patients will receive 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia

Primary Outcome Measures

Name	Time	Method
rSO2	participants will be followed for the duration of surgery, an expected average of 1 hour

Secondary Outcome Measures

Name	Time	Method
extubation time	intraoperative	time from end of anesthesia to fulfilling extubation criteria

Trial Locations

Locations (2)

King Fahd Hosital of the University; 🇸🇦 Al-Khobar, EP, Saudi Arabia

Anesthesia Department, University of Dammam; 🇸🇦 Al-Khobar, EP, Saudi Arabia