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

NCT ID: NCT01388296

Last Updated: 2013-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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 .

Conditions

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Anesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Morbidly obese patients

BMI 40-50 k/m2

No interventions assigned to this group

Morbidly obese

BMI 50-60 k/m2

No interventions assigned to this group

Morbidly obeses

BMI 60-70 k/m2

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age\< 20 and \> 40
* BMI \< 40 and \> 70
* comorbidity
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Procare Riaya Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahed ZEIDAN

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahed ZEIDAN, MD

Role: STUDY_CHAIR

Procare Riaya Hospital

Locations

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Procare Riaya Hospital

Khobar, Estern, Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Ahed ZEIDAN, MD

Role: CONTACT

Phone: 009615409107

Email: [email protected]

Facility Contacts

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kamal Abdulkhalek, MD

Role: primary

Other Identifiers

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PRH 03

Identifier Type: -

Identifier Source: org_study_id