| CTRI Number |
CTRI/2025/01/079009 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The Impact of Dexmedetomidine Infusion on plasma Glucose and lactate levels in cardiac surgery patients: A prospective Randomised Controlled Trials |
|
Scientific Title of Study
|
A Prospective Randomised Controlled Study on Effects of Dexmedetomidine Infusion on plasma glucose and lactate levels in patients undergoing cardiac surgery on cardiopulmonary bypass under general Anesthesia. |
| 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 ANGAD KUMAR SINGH |
| Designation |
Junior Resident |
| Affiliation |
Rajendra Institute of Medical Sciences Ranchi |
| Address |
Department of Anesthesiology 3rd floor, Rajendra Institute of Medical Sciences, Bariyatu, Ranchi
JHARKHAND
Ranchi
JHARKHAND
834009
India |
| Phone |
9572766033 |
| Fax |
|
| Email |
angadcherabar117@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shio Priye |
| Designation |
Professor |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology 3rd floor Rims Ranchi Jharkhand.
Ranchi
JHARKHAND
834009
India |
| Phone |
9986743162 |
| Fax |
|
| Email |
shiopriye@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nitesh Sinha |
| Designation |
Assistant Professor |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology 3rd floor Rims Ranchi Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
7860337418 |
| Fax |
|
| Email |
dr.niteshsinha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences Bariyatu Ranchi Jharkhand India Pin Code-834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Bariyatu, Ranchi, Jharkhand India
Pin Code-834009 |
| 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 Angad Kumar Singh |
Rajendra Institute of Medical Sciences |
Department of Anesthesiology 3rd floor Bariyatu Rims Ranchi Jharkhand India Pin Code-834009
Ranchi
JHARKHAND |
9572766033
angadcherabar117@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Rajendra Institute of Medical Sciences Ranchi |
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 |
| Comparator Agent |
.9% Normal Saline |
The comparator group will receive 9% normal saline at the rate of 1 mcg/kg 10 min before induction, followed by continuous infusion at the rate of .5 mcg/kg from endotracheal intubation until the completion of surgery. |
| Intervention |
Dexmedetomidine |
The Intervention group will be receiving dexmedetomidine infusion@ 1 mic/kg 10 min before induction followed by continuous infusion @.5 mic/kg from endotracheal intubation until completion of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA STATUS 2 or 3, NYHA CLASS 2, ELECTIVE SURGERY(CARDIAC) |
|
| ExclusionCriteria |
| Details |
Patients with diabetes, hypertension and congestive heart failure.
Patients/Parents/Legal Guardians unwillingness. |
|
|
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 |
| To find out the effects of Dexmedetomidine infusion on plasma Glucose and lactate levels in patients undergoing cardiac surgery on cardiopulmonary bypass under general Anesthesia |
1.Immediately after intubation
2.After completion of surgery
3. At the time of extubation
4.6 hours after extubation
5.12 hours after extubation
6. 24 hours after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine serum cortisol levels, post operative sedation scores, post operative pain scores, haemodynamics variables. |
1.Immediately after intubation
2.After completion of surgery
3.6 hours after surgery
4.12 hours after surgery
5.24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The surgery related stress response is considered a key factor of intraoperative dysglycemia. Surgery enhances sympathetic stimulation and subsequently increases levels of stress hormones glycogen synthesis, such as catecholamines, cortisol glucagon and growth hormones. Intraoperative dexmedetomidine infusion blunts the stress response and are known to be prominent in general Anesthesia, thereby decreasing the production of stress hormones that are glucose lactate and cortisol. |