A clinical trial to study intraoperative blood glucose level changes between obese and non-obese non-diabetic patients undergoing craniotomy surgery under general anaesthesia
- Conditions
- changes in perioperative BLOOD GLUCOSE levels
- Registration Number
- CTRI/2018/03/012821
- Lead Sponsor
- Department of Anaesthesiology Bangur Institute of Neurology IPGMER SSKMH
- Brief Summary
Background: Surgery causes a considerable metabolic stress in both diabetic and nondiabetic patient, but the severity of stress induced hyperglycemia is considerably high in diabetic patient . In non-diabetic subjects the stress response is more in obese population than in non-obese due to the presence of insulin resistance. The severity of surgery as well as the type of anesthesia influence the magnitude of the stress response The study was undertaken to observe the effect of stress in obese and non-obese non-diabetic patients undergoing craniotomy under general anesthesia. Methods: A Prospective randomized parallel group study was done on a total of 100 patients. They were divided into two groups non-obese patients and obese patients comprising of 50 patients in each group depending on their BMI. If at any time intraoperative CBG was found to be more than or equal to 150 mg/dL calculated dose of human soluble insulin was given as intravenous bolus equal to the amount of CBG/100 units. Number of hyperglycaemic episode and total insulin consumption in both group were the primary outcome of study. Results: 36% patients in obese population developed at least one episode of hyperglycemia (CBG ≥ 150 mg/dL) whereas only 20% patients in non-obese population had hyperglycemia episode . The relative risk of hyperglycemic in obese was higher than non-obese [ 1.80 (95% CI 0.92 to 3.51)]. The total intraoperative and postoperative insulin requirement were significantly higher in non-obese population than obese and the difference was statistically significant (p=0.02) Conclusions: We conclude that stress induced hyperglycemic response in patients undergoing craniotomy surgery under general anaesthesia is common in both diabetic and non-diabetic population and the relative risk is more in obese patients than non-obese.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
- ASA physical status I and II 2.
- non-diabetic obese patients undergoing craniotomy surgery under general anaesthesia 3.
- non-diabetic non-obese patients undergoing craniotomy surgery under general anaesthesia.
- unwilling patients 2.
- patients with severe cardiovascular, respiratory, renal and endocrine disease including diabetes mellitus 3.
- all emergency surgeries 4.
- surgeries other than neurosurgical procedures 5.
- operations under regional anaesthesia 6.
- hemodynamically unstable patients 7.
- pregnancy 8.
- ASA physical status III or more 9.
- age <18 yrs and >65 yrs.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method blood glucose level changes will be more in obese than in non-obese population and the change will increase with the duration of surgery preoperative single value, just after induction of anaesthesia and thereafter at half an hour interval till the end of operation, single value postoperatively 30 minutes after extubation
- Secondary Outcome Measures
Name Time Method insulin requirement will be more in obese than in non-obese patients and the requirement will increase with the duration of surgery 180 minutes
Trial Locations
- Locations (1)
Bangur Institute of Neurology, IPGME&R & SSKMH
🇮🇳Kolkata, WEST BENGAL, India
Bangur Institute of Neurology, IPGME&R & SSKMH🇮🇳Kolkata, WEST BENGAL, Indiasoumya chakrabartiPrincipal investigator9477137462drsoumyachakrabarti@rediffmail.com