Minimum Alveolar Concentrations of Sevoflurane for Maintaining Bispectral Index Below 50 in Morbidly Obese Patients
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|ClinicalTrials.gov Identifier: NCT01388296|
Recruitment Status : Unknown
Verified December 2013 by Ahed ZEIDAN, Procare Riaya Hospital.
Recruitment status was: Recruiting
First Posted : July 6, 2011
Last Update Posted : December 3, 2013
|Condition or disease|
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 :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Minimum Alveolar Concentrations of Sevoflurane for Maintaining Bispectral Index Below 50 in Morbidly Obese Patients|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Morbidly obese patients
BMI 40-50 k/m2
BMI 50-60 k/m2
BMI 60-70 k/m2
- Minimal alveolar concentration of Sevoflurane for Maintaining BIS Below 50 [ Time Frame: 24 hours ]
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388296
|Contact: Ahed ZEIDAN, MDfirstname.lastname@example.org|
|Procare Riaya Hospital||Recruiting|
|Al Khobar, Estern, Saudi Arabia, 3|
|Contact: kamal Abdulkhalek, MD 00966505814754 Kamal.email@example.com|
|Study Chair:||Ahed ZEIDAN, MD||Procare Riaya Hospital|