| CTRI Number |
CTRI/2023/05/053174 [Registered on: 29/05/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare two doses of intravenous Dexmedetomidine in alleviating pain on propofol injection in patients undergoing elective surgery under general anaesthesia and to assess pain score |
|
Scientific Title of Study
|
Comparative evaluation of two doses of intravenous dexmedetomidine in alleviating pain on propofol injection in patients undergoing elective surgery under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandita Kad |
| Designation |
Professor |
| Affiliation |
Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Department of anaesthesiology and critical care, Pt. B.D. Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9896335544 |
| Fax |
|
| Email |
kadnandita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandita Kad |
| Designation |
Professor |
| Affiliation |
Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Department of anaesthesiology and critical care, Pt. B.D. Sharma PGIMS, Rohtak, Haryana
HARYANA
124001
India |
| Phone |
9896335544 |
| Fax |
|
| Email |
kadnandita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaitali Pandey |
| Designation |
Post graduate resident |
| Affiliation |
Pt. B.D. Sharma PGIMS, Rohtak |
| Address |
Department of anaesthesiology and critical care, Pt. B.D. Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9036771101 |
| Fax |
|
| Email |
pandechaitali5s@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional, Pt. B.D. Sharma PGIMS, Rohtak, Haryana |
|
|
Primary Sponsor
|
| Name |
Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Rohtak, Haryana 124001 |
| 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 Nandita Kad |
Pt. B.D. Sharma, PGIMS, Rohtak |
Department of anaesthesiology and critical care, Pt. B.D. Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA |
9896335544
kadnandita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt. B.D. Sharma PGIMS, Rohtak |
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 |
An intravenous single dose of dexmedetomidine 0.2mcgkg-1 diluted with isotonic saline to a volume of 10ml to be given over 10 minutes. |
An intravenous single dose of dexmedetomidine 0.2mcgkg-1 diluted with isotonic saline to a volume of 10ml to be given over 10 minutes. After 5 minutes induction will be done with injection propofol 2mgkg-1. The assessing anaesthesiologist will use a specially designed composite pain scale to evaluate the level of propofol injection pain. The pain score is based on assessment of patients’ motor and verbal reactions, from time of propofol injection to loss of consciousness. Mean arterial pressure (MAP) and heart rate (HR) will be recorded immediately before injection of study drug, pre-induction, post-induction, pre-intubation and post-intubation. |
| Intervention |
An intravenous single dose of dexmedetomidine 0.6mcgkg-1 diluted with isotonic saline to a volume of 10ml to be given over 10 minutes. |
An intravenous single dose of dexmedetomidine 0.6mcgkg-1 diluted with isotonic saline to a volume of 10ml to be given over 10 minutes. After 5 minutes induction will be done with injection propofol 2mgkg-1. The assessing anaesthesiologist will use a specially designed composite pain scale to evaluate the level of propofol injection pain. The pain score is based on assessment of patients’ motor and verbal reactions, from time of propofol injection to loss of consciousness. Mean arterial pressure (MAP) and heart rate (HR) will be recorded immediately before injection of study drug, pre-induction, post-induction, pre-intubation and post-intubation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients belonging to American society of Anaesthesiology grade I and II
2. Age between 18-60 years
3. Either sex
4. Patients posted for elective surgery under general anaesthesia of duration 1-3hrs |
|
| ExclusionCriteria |
| Details |
1.Patients with obesity (BMI>55kgm-2)
2.Patients with history of allergy to test drug
3.Patients with history of hepatic and renal dysfunction
4.Patients with history of psychological disorders
5.Patients with history of alcohol and drug abuse
6.Patients with Heart rate <55bpm
7.Refusal to participate in the study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and study the effectiveness of two doses of intravenous dexmedetomidine in alleviating pain on propofol injection. To note down changes in HR and MAP. |
Assessment of patients’ motor and verbal reactions, from time of propofol injection to loss of consciousness.
HR and MAP will be noted : 1.Immediately before injection of study drug
2.pre-induction
3.post-induction
4.pre-intubation
5.post-intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To note the side effects of intravenous dexmedetomidine if any. |
To note the side effects of intravenous dexmedetomidine if any during the induction and intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/06/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective , randomized and double blinded study will be conducted in patients belonging to American society of anaesthesiology grade I and II between the age of 18-60 years of either sex and posted for elective surgery under general anaesthesia. All patients will be evaluated one day prior to surgery. Using random number table patients will be allocated to one of the two study groups comprising of 35 patients. Group A will receive an intravenous single dose of dexmedetomidine 0.2mcgkg-1 diluted with isotonic saline to a volume of 10ml to be given over 10 minutes. Group B will receive in intravenous single dose of dexmedetomidine 0.6mgkg-1 diluted with isotonic saline to a volume of 10ml to be given over 10 minutes. After 5 minutes induction will be done with injection propofol 2mgkg-1. The assessing anaesthesiologist will use a specially designed composite pain scale to evaluate the level of propofol injection pain. The pain score is based on assessment of patients’ motor and verbal reactions, from time of propofol injection to loss of consciousness. Pain graded on a 0-6 point scale, with a score >2 considered unacceptable. MAP and HR will be recorded immediately before injection of study drug , pre-induction, post-induction, pre-intubation and post-intubation. Complications such as bradycardia and hypotension will be recorded and treated accordingly. |