Mannitol Improves Cerebral Oxygen Saturation

Imam Abdulrahman Bin Faisal University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Mannitol; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02091180

2012069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Mannitol

Experimental group

Description:

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

Treatment:

Drug: Mannitol

Control

Placebo Comparator group

Description:

Patients will receive normal saline

Treatment:

Drug: Control