| 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
|
|
|
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
|
|
|
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) |