| CTRI Number |
CTRI/2025/03/083273 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to see if Dexmedetomidine (a sleep drug) helps in blood sugar control during laparoscopic surgeries in diabetic patients. |
|
Scientific Title of Study
|
Efficacy of Intravenous Dexmedetomidine on Intraoperative Insulin requirement among adults with Diabetes Mellitus undergoing Laparoscopic Surgery under General Anaesthesia- a Randomized placebo-controlled trial |
| 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 Surya S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal
Institute of Postgraduate Medical Education and Research
(JIPMER), JIPMER Campus Road, Gorimedu, Dhanvantari Nagar,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7339407504 |
| Fax |
|
| Email |
nithinsurya44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasan R |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal
Institute of Postgraduate Medical Education and Research
(JIPMER), JIPMER Campus Road, Gorimedu, Dhanvantari Nagar,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9940394386 |
| Fax |
|
| Email |
srinijipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surya S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal
Institute of Postgraduate Medical Education and Research
(JIPMER), JIPMER Campus Road, Gorimedu, Dhanvantari Nagar,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7339407504 |
| Fax |
|
| Email |
nithinsurya44@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Intramural Research fund,
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), JIPMER
Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Surya S |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
Department of Anaesthesiology and critical care, Jawaharlal Institute of
Postgraduate Medical
Education and
Research (JIPMER),
JIPMER Campus Rd,
Gorimedu, Dhanvantari
Nagar, Puducherry,
605006
Pondicherry
PONDICHERRY |
7339407504
nithinsurya44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Interventional Studies, JIPMER, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Intravenous Dexmedetomidine 0.5
mcg/kg over 20 minutes after induction of anaesthesia followed by 0.5 mcg/kg/hour continuous infusion till the deflation of pneumoperitoneum.
|
| Comparator Agent |
Placebo control |
an intravenous infusion of 0.9% normal saline administered in the same manner as the study drug
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults aged 18 to 70 years with diabetes mellitus with ASA PS 2 and 3 scheduled to undergo elective laparoscopic surgery under general anaesthesia.
2) Duration of pneumoperitoneum, minimum 2 hours and maximum 6 hours.
3) Preoperative baseline blood sugar value, less than 180 mg/dL
|
|
| ExclusionCriteria |
| Details |
1) Patients with known allergy to dexmedetomidine
2) Patients with severe cardiovascular disease or pulmonary disease, end-stage renal disease or decompensated liver disease.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The number/percentage of patients requiring intraoperative insulin |
No specific time points for this outcome measure. Capillary blood sugar values will be measured at baseline, and then every hour after starting dexmedetomidine infusion till the end of surgery. Insulin infusion will be started if blood sugar value is found to be higher than 180mg/dL intraoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters - Heart rate, blood pressure, mean arterial pressure |
every 5 minutes for 60 minutes after initiating drug infusion, and then every 15 minutes till the end of surgery and extubation |
| Serum cortisol and IL-6 levels |
before induction of anaesthesia and just before deflation of pneumoperitoneum
|
| Incidence of hypoglycemia |
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/04/2025 |
| 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="2"
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
|
This study is a randomized, double blinded, placebo controlled trial assessing the efficacy of Intravenous Dexmedetomidine on Intraoperative Insulin requirement among adults with Diabetes Mellitus undergoing Laparoscopic Surgery under General Anaesthesia and will be conducted in JIPMER, Puducherry as a part of post-graduate dissertation. The primary outcome measure will be the number/percentage of patients requiring intraoperative insulin. The secondary outcomes will be intraoperative hemodynamic parameters such as heart rate, blood pressure, mean arterial pressure; and the levels of cortisol and IL-6 measured before induction of anaesthesia and then just before deflation of pneumoperitoneum. The proposed hypothesis is that Intravenous Dexmedetomidine is effective in reducing the requirement of intraoperative insulin among diabetic adults undergoing laparoscopic surgeries. |