Clinical trial NCT01388296: Minimum Alveolar Concentrations of Sevoflurane for Maintaining Bispectral Index Below 50 in Morbidly Obese Patients
Official title: Minimum Alveolar Concentrations of Sevoflurane for Maintaining Bispectral Index Below 50 in Morbidly Obese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Lead sponsor: Procare Riaya Hospital
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Morbidly obese patients weighting BMI 40-70 k/m2

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.

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 .

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Minimal alveolar concentration of Sevoflurane for Maintaining BIS Below 50
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Al Khobar
country: Saudi Arabia
facility: Procare Riaya Hospital
state: Estern
Study officials:
affiliation: Procare Riaya Hospital
name: Ahed ZEIDAN, MD
role: STUDY_CHAIR
References: