| CTRI Number |
CTRI/2025/12/099959 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the Effects of Two Different Drugs on Blood Pressure monitoring During Surgery and duration of pain relief after Laproscopic Sterization |
|
Scientific Title of Study
|
Comparision of an Intraoperative Infusion of Dexmedetomidine and Remifentanil on Intraoperative Hemodyanamic and Postoperative Recovery after Laproscopic Sterization- A Prospective Randamized Control 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 |
Mahesh kumar M |
| Designation |
Post graduate |
| Affiliation |
SRM medical college and research centre |
| Address |
Room No. 209, B-block, 2nd floor, department of anesthesiology, SRM medical college hospital and research centre , kattankulathur campus , chengalpattu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09791196482 |
| Fax |
|
| Email |
muruganmahesh97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karthik K |
| Designation |
Professor MD anesthesia |
| Affiliation |
SRM medical college and research centre |
| Address |
Room No. 209, B-Block, 2nd Floor, Dept of Anaesthesiology, SRM medical college hospital and research centre , kattankulathur campus , chengalpattu 603203
Kancheepuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884360796 |
| Fax |
|
| Email |
karthikkrishnamoorthy1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahesh kumar M |
| Designation |
POST GRADUATE |
| Affiliation |
SRM medical college and research centre |
| Address |
Room No. 209, B-Block, 2nd Floor, Dept of Anaesthesiology, SRM medical college hospital and research centre , kattankulathur campus , chengalpattu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09791196482 |
| Fax |
|
| Email |
muruganmahesh97@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Room No. 209, B-Block, 2nd Floor, Dept of Anaesthesiology, SRM medical college hospital and research centre , kattankulathur campus , chengalpattu 603203
Kancheepuram
TAMIL NADU
603203
India |
| 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 |
| Dr Mahesh kumar M |
SRM medical college hospital and research centre |
Room No. 209, B-Block, 2nd Floor, Dept of Anaesthesiology, SRM medical college hospital and research centre , kattankulathur campus , chengalpattu 603203
Kancheepuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU |
9791196482
muruganmahesh97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O08||Pregnancy with abortive outcome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To compare the intraoperative hemodynamic and postoperative
recovery after laparoscopic sterilization |
A loading dose of dexmedetomidine will be administered before anesthesia induction at
0.7 microgram per kilogram for 10 minutes and followed by a continuous infusion of Injection Propofol 3 microgram per mililitre and
Injection Dexmeditomidine 0.5 microgram per kilogram. Injection propofol and Dexmedetomidine will be
discontinued at completion of surgery that is at the end of late suture. |
| Comparator Agent |
To compare the intraoperative hemodynamic and postoperative recovery after laparoscopic sterilization A loading dose of dexmedetomidine will be administered before anesthesia induction at 0.7 microgram per kilogram for 10 minutes and followed by a continuous infusion of Injection Propofol 3 microgram per mililitre and Injection Dexmeditomidine 0.5 microgram per kilogram. Injection propofol and Dexmedetomidine will be discontinued at completion of surgery that is at the end of late suture.
|
A loading dose of Remifentanil 1.5 microgram per kiligram will be administered before anesthesia induction
and followed by a continuous infusion of Injection Propofol 3 microgram per milliliter and Injection ramifentanil 0.15
microgram per kilgram per minutes. Injection propofol and Remifentanil will be discontinued at completion of surgery that is at the end of late suture. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.American society of anesthesiologist physical status grade I, grade II
2.Patient undergoing laparoscopic sterilization |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patients with severe cardiovascular, respiratory, renal, or hepatic diseases
3.known allergies or hypersensitivity to dexmedetomidine, remifentanil
4.Severe Obesity - BMI 35-40
5.History of substance abuse or opioid dependency |
|
|
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 compare the intra operative hemodynamic parameters between dexmedetomidine
and remifentanil group undergoing laparoscopic sterilization |
0-60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the recovery profile between dexmedetomidine and remifentanil group
using modified Aldrete score. |
starting from immediate post surgery and every 15 minutes till 30 minutes |
| To compare the immediate post operative pain |
Duration of post operative pain (dexmedetomidine/remifentanil)in minutes |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
22/01/2026 |
| 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
|
Remifentanil is an ultra-short-acting opioid and a favorable alternative to long-acting opioids during general anesthesia. It is 100 to 200 times more potent than morphine, with a short elimination half-life and context-sensitive half-life, leading to faster recovery with predictable offset. Dexmedetomidine is another commonly used non-opioid drug in anesthesia practice. It is a selective Alpha 2 Agonist having sedative, anxiolytic, hypnotic, analgesic and sympatholytic properties. Each of the drug has its own set of uses and side effects and has been increasingly used in perioperative clinical settings owing to their sedative and analgesic properties. we hypothesise that Dexmedetomidine provides more effective intra operative haemodyanamics compared to remifentanil in patients undergoing laparoscopic sterilization |