Minimum Alveolar Concentrations of Sevoflurane for Maintaining Bispectral Index Below 50 in Morbidly Obese Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Anesthesia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Minimum Alveolar Concentrations of Sevoflurane for Maintaining Bispectral Index Below 50 in Morbidly Obese Patients |
- Minimal alveolar concentration of Sevoflurane for Maintaining BIS Below 50 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
Bisbectral index (BIS)
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Morbidly obese patients
BMI 40-50 k/m2
|
|
Morbidly obese
BMI 50-60 k/m2
|
|
Morbidly obeses
BMI 60-70 k/m2
|
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| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Morbidly obese patients weighting BMI 40-70 k/m2
Inclusion Criteria:
- morbidly obese patient
- BMI 40-70
- age : 20-40 year
Exclusion Criteria:
- Age< 20 and > 40
- BMI < 40 and > 70
- comorbidity
Contacts and Locations| Contact: Ahed ZEIDAN, MD | 009615409107 | doczeidan@hotmail.com |
| Saudi Arabia | |
| Procare Riaya Hospital | Recruiting |
| Al Khobar, Estern, Saudi Arabia, 3 | |
| Contact: kamal Abdulkhalek, MD 00966505814754 Kamal.abdulkhaleq@procare.com.sa | |
| Study Chair: | Ahed ZEIDAN, MD | Procare Riaya Hospital |
More Information
No publications provided
| Responsible Party: | Ahed ZEIDAN, MD, Procare Riaya Hospital |
| ClinicalTrials.gov Identifier: | NCT01388296 History of Changes |
| Other Study ID Numbers: | PRH 03 |
| Study First Received: | June 30, 2011 |
| Last Updated: | December 7, 2012 |
| Health Authority: | Saudi Arabia: Ethics Committee |
Additional relevant MeSH terms:
|
Sevoflurane Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Anesthetics, Inhalation |
Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013