Mannitol Improves Cerebral Oxygen Saturation

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091180
• Other study ID #: 2012069
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2014
• Last updated: March 18, 2014
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Dammam University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Mannitol
0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia
• Control
Saline infusion

Locations

Country	Name	City	State
Saudi Arabia	Anesthesia Department, University of Dammam	Al-Khobar	EP
Saudi Arabia	King Fahd Hosital of the University	Al-Khobar	EP

Sponsors (1)

Lead Sponsor	Collaborator
Dammam University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OAA/S	alertness/sedation scale	after surgery 30 minutes.	No
Primary	rSO2		participants will be followed for the duration of surgery, an expected average of 1 hour	Yes
Secondary	extubation time	time from end of anesthesia to fulfilling extubation criteria	intraoperative	No