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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Procare Riaya Hospital
Sponsor:
Information provided by (Responsible Party):
Ahed ZEIDAN, Procare Riaya Hospital
ClinicalTrials.gov Identifier:
NCT01388296
First received: June 30, 2011
Last updated: December 2, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by Procare Riaya Hospital:

Primary Outcome Measures:
  • 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 2013
Estimated Primary Completion Date: December 2013 (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
Study Population

Morbidly obese patients weighting BMI 40-70 k/m2

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388296

Contacts
Contact: Ahed ZEIDAN, MD 009615409107 doczeidan@hotmail.com

Locations
Saudi Arabia
Procare Riaya Hospital Recruiting
Al Khobar, Estern, Saudi Arabia, 3
Contact: kamal Abdulkhalek, MD    00966505814754    Kamal.abdulkhaleq@procare.com.sa   
Sponsors and Collaborators
Procare Riaya Hospital
Investigators
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 2, 2013
Health Authority: Saudi Arabia: Ethics Committee

Additional relevant MeSH terms:
Sevoflurane
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014