Minimum Alveolar Concentrations of Sevoflurane for Maintaining Bispectral Index Below 50 in Morbidly Obese Patients

December 2, 2013 updated by: Ahed ZEIDAN, Procare Riaya Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

After ethical committee approval and written informed consent, 30 morbidly obese adult patients , BMI 40- 70Kg/m², ASA physical status 1 and 2 , aged 18-49 yr, , undergoing elective bariatric surgery under general anesthesia using sevoflurane, were included in this study.

Monitoring consisted of noninvasive blood pressure, Electrocardiogram (ECG) , pulse oximetry, and BIS. All subjects received a standard dose of 2 mcg/kg fentanyl approximately 20 min before induction of general anesthesia. a standard BIS® monitor strip was applied before fentanyl administration and induction of general anesthesia. Induction was performed in all patients with 2m/kg propofol, 0.2 mg/kg cisatracuruim, followed by direct laryngoscopy and tracheal intubation. Therefore, when BIS reached > 65 , sevoflurane was started immediately at the predetermined dose.

The endtidal sevoflurane concentration was adjusted with starting dose for the first cohort patients 1% and maintained for 10 min to ensure equilibration with the cerebral anesthetic partial pressure followed by a 1-min assessment of BIS taken at 10-s intervals. Briefly, a first dose is given to the first patient and the next doses are given according to the following rule: if the subject responds positively (BIS<50), the dose is decreased one step for the next subject, and conversely, if the subject does not respond (BIS>50), the dose is increased one step. The dose adjustment is 0.2% for sevoflurane. The CRM is used to calculate the dose adjustment for every cohort with the number of patients for every cohort .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Morbidly obese patients weighting BMI 40-70 k/m2

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Morbidly obese patients
BMI 40-50 k/m2
Morbidly obese
BMI 50-60 k/m2
Morbidly obeses
BMI 60-70 k/m2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Minimal alveolar concentration of Sevoflurane for Maintaining BIS Below 50
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Procare Riaya Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRH 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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