NCT02091180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

10 months

First QC Date

March 15, 2014

Last Update Submit

March 18, 2014

Conditions

Anesthesia

Keywords

AnesthesiaRecoverylaparoscopycholecystectomy

Outcome Measures

Primary Outcomes (1)

  • rSO2

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

Secondary Outcomes (1)

  • extubation time

    intraoperative

Other Outcomes (1)

  • OAA/S

    after surgery 30 minutes.

Study Arms (2)

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

MannitolDRUG

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

Also known as: mannite or manna sugar
Mannitol
ControlDRUG

Saline infusion

Also known as: Saline
Control

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • obstructive or restrictive pulmonary disease
  • cardiac dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Anesthesia Department, University of Dammam

Khobar, EP, 31952, Saudi Arabia

Location

King Fahd Hosital of the University

Khobar, EP, 31952, Saudi Arabia

Location

MeSH Terms

Interventions

MannitolSodium Chloride

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Hany A Mowafi, MD

    Imam Abdulrahman Bin Faisal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 15, 2014

First Posted

March 19, 2014

Study Start

January 1, 2013

Primary Completion

November 1, 2013

Study Completion

February 1, 2014

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations

SA(2)