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Completed

NCT Number: NCT02091180

Mannitol Improves Cerebral Oxygen Saturation

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.

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Key information

Conditions

Anesthesia

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anesthesia Department, University of Dammam, Khobar, EP, Saudi Arabia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

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

Other names: mannite or manna sugar

Control

Drug

Saline infusion

Other names: Saline

Primary outcomes

  1. rSO2

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

Secondary outcomes

  1. extubation time

    Time frame: intraoperative

    time from end of anesthesia to fulfilling extubation criteria

Other outcomes

  1. OAA/S

    Time frame: after surgery 30 minutes.

    alertness/sedation scale

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 19, 2014
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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