Mannitol Improves Cerebral Oxygen Saturation

NCT ID: NCT02091180

Last Updated: 2014-03-19

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mannitol

Patients will receive 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia

Group Type EXPERIMENTAL

Mannitol

Intervention Type DRUG

0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia

Control

Patients will receive normal saline

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

Saline infusion

Interventions

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Mannitol

0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia

Intervention Type DRUG

Control

Saline infusion

Intervention Type DRUG

Other Intervention Names

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mannite or manna sugar Saline

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role lead

Responsible Party

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Hany A. Mowafi

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hany A Mowafi, MD

Role: STUDY_DIRECTOR

Imam Abdulrahman Bin Faisal University

Locations

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Anesthesia Department, University of Dammam

Khobar, EP, Saudi Arabia

Site Status

King Fahd Hosital of the University

Khobar, EP, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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2012069

Identifier Type: -

Identifier Source: org_study_id

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