Mannitol Improves Cerebral Oxygen Saturation

Effect of Preoperative Mannitol Infusion on Cerebral Oxygen Saturation and Patients' Recovery After Laparoscopic Cholecystectomy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02091180

Enrollment

Registered

2014-03-19

Start date

2013-01-31

Completion date

2014-02-28

Last updated

2014-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Anesthesia, Recovery, laparoscopy, cholecystectomy

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.

Interventions

DRUGMannitol

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

DRUGControl

Saline infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 50 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
extubation time	intraoperative	time from end of anesthesia to fulfilling extubation criteria

Other

Measure	Time frame	Description
OAA/S	after surgery 30 minutes.	alertness/sedation scale

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026