CTRI Number |
CTRI/2012/09/003021 [Registered on: 26/09/2012] Trial Registered Retrospectively |
Last Modified On: |
05/06/2014 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Increase in blood glucose during surgey |
Scientific Title of Study
|
Intraoperative blood glucose levels in nondiabetic patients undergoing elective major surgery under general anaesthesia receiving crystalloid solutions for maintenance fluid |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Souvik Maitra |
Designation |
Post Graduate Resident |
Affiliation |
IPGME&R, SSKM Hospital, Kolkata |
Address |
162 MM Ghosh Road,
Dumdum
Kolkata 242 AJC Bose Road,
Kolkata- 700020
WB Kolkata WEST BENGAL 700074 India |
Phone |
|
Fax |
|
Email |
souvikmaitra@live.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Samarendra Pal |
Designation |
Professorr |
Affiliation |
|
Address |
Department of Anaesthesiology,
Main Block, 2nd Floor,
IPGME&R and SSKM Hospital,
244 AJC Bose Road
Kolkata WEST BENGAL 700020 India |
Phone |
|
Fax |
|
Email |
palsamarendra@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Souvik Maitra |
Designation |
Post Graduate Resident |
Affiliation |
IPGME&R, SSKM Hospital, Kolkata |
Address |
162 MM Ghosh Road,
Dumdum
Kolkata
Kolkata WEST BENGAL 700074 India |
Phone |
|
Fax |
|
Email |
souvikmaitra@live.com |
|
Source of Monetary or Material Support
|
Personal funding: The expenses of glucometer and glucose-sticks were bought by the principal investigator. |
|
Primary Sponsor
|
Name |
Souvik Maitra |
Address |
Flat A1,
162 MM Ghosh Road
Dumdum,Kolkata- 74 |
Type of Sponsor |
Other [Personal funding] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Souvik Maitra |
Main Operation Theatre, Main Block Second Floor |
IPGMER & SSKM Hospital
244 AJC Bose Road,
Kolkata- 20 Kolkata WEST BENGAL |
9968859756
souvikmaitra@live.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committe, IPGMER, Kolkata |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Glycemic status during intraoperative period, |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Comparator Agent |
5% Dextrose |
Patients in Gr B received 5% dextrose- 0.45% NaCl with 10 meq/l KCl as maintenance fluid.
Fluid infusion rate will be according to the "4-2-1" rule and duration is throughout the surgery. |
Comparator Agent |
Ringer lactate |
Patients in Gr A received RL as maintenance fluid.
Fluid infusion rate will be according to the "4-2-1" rule and duration is throughout the surgery. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Nondiabetic patients of ASA physical status I or II of age group 18-60 years of either sex undergoing major noncardiac surgery (duration > 2 hours) under general anaesthesia. |
|
ExclusionCriteria |
Details |
ï‚§ Unwilling patients
ï‚§ Patients with diabetes mellitus, impaired postprandial glucose tolerance (2h postprandial blood glucose > 126 mg/dL) and impaired fasting glucose (fasting blood glucose > 106 mg/dL)
ï‚§ Patients with severe respiratory, cardiovascular, neurological or renal disease
ï‚§ ASA physical status III and IV
ï‚§ Haemodynamically unstable patients
ï‚§ Pregnancy
ï‚§ Body weight < 35 kg
ï‚§ Body weight > 75 kg
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Incidence of intraoperative hyperglycemia (Blood glucose 150 mg/dl) |
Blood glucose was assessed initially just before iv cannulation and again at hourly interval till the end of surgery. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Requirement of insulin to maintain normoglycemia |
When we find a Blood glucose level is higher than 150 mg/dl during CBG monitoring, designated dose of Insulin was administered. Total requirement of Insulin was calculated |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
22/01/2010 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
BACKGROUND The study was undertaken to observe the effect of different maintenance fluid regimen on intraoperative blood glucose levels in nondiabetic patients undergoing elective major noncardiac surgery under general anaesthesia. METHODS Two hundred nondiabetic patients (100 in each group) aged between 18 and 60 yrs were enrolled for this prospective randomized parallel group study. Group A patients received Ringer’s lactate solution and group B patients received 0.45% sodium chloride with 5% dextrose and 20 mmol/L potassium chloride as maintenance fluid. Capillary blood glucose (CBG) level was measured immediately before initiation of intravenous fluid therapy and there after hourly till the end of surgery. 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. RESULTS 63% patients in group B developed at least one episode of hyperglycemia (CBG ≥ 150 mg/dL) but only 29% in the group A did so. Insulin consumption was significantly higher in group B than in group A to maintain normoglycemia. The relative risk of becoming hyperglycemic in group B patients is 2.172 (95% CI 1.544 to 3.057). Number needed to harm, i.e. hyperglycemia, in group B is 2.941 (95% CI 2 to 5). CONCLUSION We conclude that stress induced hyperglycemic response in patients undergoing major noncardiac surgery is common in nondiabetic population. Maintenance fluid therapy by dextrose containing solution as opposed to RL solution increases the incidence of hyperglycemia. To achieve normoglycemia by intravenous bolus dose of human regular insulin, significantly higher doses are required in patients receiving dextrose containing saline as maintenance fluid. |