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CTRI Number  CTRI/2024/06/068738 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Blood glucose concentration on diabetic and non diabetic patient after single dose of Inj.dexamethasone given intraoperatively. 
Scientific Title of Study   The effect of single intraoperative dose of dexamethasone on the blood glucose concentration in diabetic and non-diabetic patients : A Double blinded randomised control study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nadia Rose 
Designation  Associate Professor 
Affiliation  Rajarajeswari medical college and hospital 
Address  Department of Anesthesia and critical care, Rajarajeswari medical college and hospital, 202, Kambipura, Mysore road, Bangalore.

Bangalore
KARNATAKA
560074
India 
Phone  9444960258  
Fax    
Email  dr.nadia.rose@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nadia Rose 
Designation  Associate Professor 
Affiliation  Rajarajeswari medical college and hospital 
Address  Department of Anesthesia and critical care, Rajarajeswari medical college and hospital, 202, Kambipura, Mysore road, Bangalore.


KARNATAKA
560074
India 
Phone  9444960258  
Fax    
Email  dr.nadia.rose@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nadia Rose 
Designation  Associate Professor 
Affiliation  Rajarajeswari medical college and hospital 
Address  Department of Anesthesia and critical care, Rajarajeswari medical college and hospital, 202, Kambipura, Mysore road, Bangalore.


KARNATAKA
560074
India 
Phone  9444960258  
Fax    
Email  dr.nadia.rose@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology ,2nd floor, Rajarajeswari medical college and hospital,Bangalore-560074. 
 
Primary Sponsor  
Name  Rajarajeswari Medical college and hospital 
Address  Department of Anaesthesiology ,2nd floor, Rajarajeswari medical college and hospital,Bangalore-560074. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nadia Rose  Rajarajeswari medical college and hospital  Department of Anaesthesiology,Rajarajeswari medical college and hospital,Kambipura,Mysore road,Bangalore
Bangalore
KARNATAKA 
9444960258

dr.nadia.rose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Dexamethasone given for diabetic and non diabetic patient intraoperatively in patient undergoing laparoscopic surgery under General anesthesia   Dexamethasone of 4 mg/ml dilution (labeled A) , given intravenously as single dose in patient undergoing laparoscopic surgery under general anesthesia 
Comparator Agent  Normal saline given for diabetic and non diabetic patient intraoperatively in patient undergoing laparoscopic surgery under General anesthesia  Normal saline (labeled B) , given intravenously as single dose in patient undergoing laparoscopic surgery under general anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.ASA I, II
2.Patients undergoing general anesthesia for elective Laparoscopic surgeries 
 
ExclusionCriteria 
Details  Preoperative use of steroids,Peptic Ulcer,Pregnancy,Malignancy,Immunosuppression,Severe Renal Impairment,Pre-operative blood glucose levels greater than 11.1 mmol.l
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Blood sugar values   Two hours after dexamethasone /placebo administration as well as FBS and PPBS on POD 1,2. 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative nausea & vomiting  Post operative period 2,8 hour,pod1,2. 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Double blinded, randomized, controlled study
Written informed consent will be taken from willing patients posted for elective surgery under general anesthesia. Pre operative blood sugar values will be documented along with age, gender, body mass index, type of surgery.
Double blinding will be ensured by using preloaded 2 ml syringe of dexamethasone of 4 mg/ml dilution (labeled A) and saline (labeled B), prepared by an anesthesia resident unaware of allocation, after the opening of a sealed opaque envelope containing the randomized assignment. Patients will be allocated to one of four groups: non-diabetics receiving saline; non-diabetics receiving dexamethasone; diabetics receiving saline; and diabetics receiving dexamethasone. 

The study drug or saline control will be administered at induction of anesthesia. No dextrose containing solution will be administered during the study. In the OT after attaching standard ASA monitors, anesthesia will be induced with propofol iv after premedication with intravenous glycopyrrolate, Midazolam, ondansetron 4mg, fentanyl. Muscle relaxation will be achieved with atracurium 0.5mg/kg and endotracheal intubation done. At the end of surgery patients will be extubated after reversal of neuromuscular blockade. For the diabetic patient intraoperatively blood glucose monitoring will be done as per protocol. 
All blood glucose levels will be measured using a calibrated glucometer, SD code free (SD Biosensor,Inc.).The blood glucose measurements will be obtained from finger prick capillary blood samples, by anaesthesiology resident blinded to study group The total amount of insulin administered for the treatment of perioperative hyperglycemia will be recorded. Standard treatment care will be given to diabetic patients. 

Blood sugar values two hours after dexamethasone /placebo administration as well as FBS and PPBS on POD 1,2 will be taken as primary endpoints.
PONV will be assessed using a 4-point verbal descriptive scale which consists of score 0=no PONV, score1 = mild PONV: patient complaints of nausea but refuses antiemetic treatment, score 2 = moderate PONV: patient complaints of nausea and needs antiemetic treatment; score 3= severe PONV. 

Patients who experience PONV in the recovery area will be treated with intravenous metoclopramide (10 mg) 
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