| CTRI Number |
CTRI/2025/07/092106 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare efficacy of two drugs, dexmedetomidine and remifentanil affect adult diabetic patients having heart surgery and requiring heart-lung machine |
|
Scientific Title of Study
|
Effect of dexmedetomidine and remifentanil on perioperative glycaemic control in adult diabetic cardiac surgical patient requiring cardiopulmonary bypass:A Randomised controlled 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 |
DR PEMA NAMGYAL SHERPA |
| Designation |
Junior Resident |
| Affiliation |
Ind ira GandhiInstitute of Medical Science |
| Address |
Department of Anesthesiology Indira Gandhi Institute of Medicine Science, Sheikhpura,Patna, Bihar,800014
Patna
BIHAR
800014
India |
| Phone |
7076681639 |
| Fax |
|
| Email |
fpemanamgyal444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PEMA NAMGYAL SHERPA |
| Designation |
Junior Resident |
| Affiliation |
Ind ira GandhiInstitute of Medical Science |
| Address |
Department of Anesthesiology Indira Gandhi Institute of Medicine Science, Sheikhpura,Patna, Bihar,800014
Patna
BIHAR
800014
India |
| Phone |
7076681639 |
| Fax |
|
| Email |
fpemanamgyal444@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ALOK KUMAR BHARTI |
| Designation |
Associate Professor |
| Affiliation |
Ind ira GandhiInstitute of Medical Science |
| Address |
Department of Anesthesiology Indira Gandhi Institute of Medical Science, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
7076681639 |
| Fax |
|
| Email |
alok.bharti48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Indira Gandhi Institute of Medical Science, Sheikhpura,Patna,India, 800014 |
|
|
Primary Sponsor
|
| Name |
DR PEMA NAMGYAL SHERPA |
| Address |
Department of Anesthesiology, Indira Gandhi Institute of Medical Science, Sheikhpura,Patna, India, 800014 |
| Type of Sponsor |
Government 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 |
| DR PEMA NAMGYAL SHERPA |
Indira Gandhi Institute of Medical Science, Patna |
Department of Anesthesiology Indira Gandhi Institute of Medicine Science, Sheikhpura,Patna, Bihar,800014
Patna
BIHAR |
07076681639
fpemanamgyal444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I248||Other forms of acute ischemic heart disease, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effect of dexmedetomidine on perioperative glycaemic control in adult diabetic cardiac patients |
Group DEX will receive dexmedetomedine before induction of anesthesia at rate 0.5 mcg/ kg/ hr diluted in 20ml normal saline intravenously till 5th hour of postoperative period |
| Intervention |
Effect of remifentanil on perioperative glycaemic control in adult diabetic cardiac patients |
Group REM will receive remifantil before induction of anesthesia at rate 0.25 mcg/kg/hr diluted with 20 ml normal saline intravenously till 5th postoperative hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA II-III
2.Patients able to comprehend and willing to participate
3.Patients scheduled for elective cardiac surgery through midline sternotomy with use of CPB |
|
| ExclusionCriteria |
| Details |
1. Patients refusal to participate
2. Participate with left ventricular ejection less than 30%
3. Emergent or redo surgeries
4. Minimal invasive cardiac surgeries
5. Patients with heart block or heart rate less than 50 beats/min
6. Use of regional anesthesia
7. Severe organ dysfunction (Renal/ Liver insufficiencies). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effects of dexmedetomidine and remifentanil infusion on blood glucose level |
T0 before induction till 5th postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study the requirements of regular insulin, effect of glucose control in patients with controlled & uncontrolled diabetes & hemodynamic parameters |
T0 before induction till 5th postoperative period |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
12/08/2025 |
| 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="1"
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
|
A total of 64 patients posted for elective coronary artery bypass ( CABG) surgery with history of diabetes mellitus will be randomly divided into two groups ( 32 each) group dexmedetomidine and group remifentanil. We will compare effective of dexmedetomidine and remifentanil in perioperative hyperglycaemia patients. Intraoperative blood glucose level will be kept less than 180 mg/dl using regular insulin as per vellore regimen, observations will recorded by an independent observer during the study period: (1) heart rate (HR), MAP, blood glucose level, and serum potassium level will noted at six different time points: before induction of anesthesia (T0), after sternotomy (T1), after establishment of CPB (T2), termination of CPB (T3), after transferring the patient to the intensive care unit (T4) and at 5th hour of the postoperative period (T5), (2) total insulin dose required to maintain the blood glucose levels <180 mg/dl during the study period, (3) hyperglycaemia episodes (blood glucose levels >180 mg/dl), (4) incidence of postoperative arrhythmias and delirium till 72 hours after extubation.( 5) Sedation level and (6) incidence of stroke, myocardial ischemia, and mortality till discharge from hospital.
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