Mannitol Improves Cerebral Oxygen Saturation | NCT02091180

Studies
Mannitol Improves Cerebral Oxygen Saturation

NCT02091180

Sponsor

Imam Abdulrahman Bin Faisal University

Status

Completed

Last Update Posted

Mar 19, 2014Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Anesthesia

Interventions

Mannitol
Control

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Mar 15, 2014

First Submission Date that Met QC Criteria

Mar 18, 2014

First Posted Date

Mar 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2014

Last Update Posted Date

Mar 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hany A. Mowafi, Associate professor, Imam Abdulrahman Bin Faisal UniversityPrincipal Investigator

Lead Sponsor

Imam Abdulrahman Bin Faisal UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mannitol	Experimental	Patients will receive 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia	Drug: Mannitol
Control	Placebo Comparator	Patients will receive normal saline	Drug: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mannitol	Drug	0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia	Mannitol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hany A Mowafi, MD	Imam Abdulrahman Bin Faisal University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthesia Department, University of Dammam		Khobar	EP	31952	Saudi Arabia
King Fahd Hosital of the University

Intervention Browse Module

MeSH Terms

ID	Term
D008353	Mannitol
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates

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Browse Branches

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