NCT01388296

Brief Summary

the target of this study is to assess the minimum alveolar concentration of sevoflurane to maintain theBispectral Index below 50.The minimum alveolar concentration (MAC) for maintaining Bispectral Index below 50 (MACBIS50) of sevoflurane has been reported previously in adult with Body Mass Index ( BMI) \< 40 to be 0.97 and in enfant to be 2.83%, However, there is no study assessed theBispectral Index below 50 (MACBIS50 ) in morbidly obese patient (BMI \> 40). The first aim of our study is to assess the MACBIS50 of sevoflurane in morbidly obese patients BMI 40 - 70 using the Continuous Reassessment Method (CRM) in 80 % of patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

2.5 years

First QC Date

June 30, 2011

Last Update Submit

December 2, 2013

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Minimal alveolar concentration of Sevoflurane for Maintaining BIS Below 50

    24 hours

Study Arms (3)

Morbidly obese patients

BMI 40-50 k/m2

Morbidly obese

BMI 50-60 k/m2

Morbidly obeses

BMI 60-70 k/m2

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Morbidly obese patients weighting BMI 40-70 k/m2

You may qualify if:

  • morbidly obese patient
  • BMI 40-70
  • age : 20-40 year

You may not qualify if:

  • Age\< 20 and \> 40
  • BMI \< 40 and \> 70
  • comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Procare Riaya Hospital

Khobar, Estern, 3, Saudi Arabia

RECRUITING

Biospecimen

Retention: NONE RETAINED

Bisbectral index (BIS)

Study Officials

  • Ahed ZEIDAN, MD

    Procare Riaya Hospital

    STUDY CHAIR

Central Study Contacts

Ahed ZEIDAN, MD

CONTACT

009615409107doczeidan@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 6, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations

SA(1)