| CTRI Number |
CTRI/2025/02/080428 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluating the Effect of Dexmedetomidine on Blood Pressure During Minimally Invasive Laparoscopic Surgery |
|
Scientific Title of Study
|
To evaluate the effectiveness of intravenous
dexmedetomidine infusion on intraoperative
hemodynamics during laparoscopic surgery
: A prospective randomised 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 Veena Patodi |
| Designation |
Senior professor |
| Affiliation |
JLN medical college and hospital |
| Address |
Department of Anaesthesiology, new OT, 1st floor, JLN hospital,Kala bagh, Ajmer, Rajasthan, PIN 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior professor |
| Affiliation |
JLN medical college and hospital |
| Address |
Department of Anaesthesiology, new OT, 1st floor, JLN hospital,Kala bagh, Ajmer, Rajasthan, PIN 305001
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior professor |
| Affiliation |
JLN medical college and hospital |
| Address |
Department of Anaesthesiology, new OT, 1st floor, JLN hospital,Kala bagh, Ajmer, Rajasthan, PIN 305001
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, JLN hospital Ajmer, Rajasthan, India, PIN 305001 |
|
|
Primary Sponsor
|
| Name |
JLN medical college and hospital |
| Address |
Kala bagh, Ajmer,Rajasthan, pin 305001 |
| 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 Dakshani |
JLN hospital |
Department of anaesthesiology
new OT, 1st floor, JLN hospital, Kala bagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN |
7022107696
babshettydakshani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee JLN Ajmer |
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 |
Group C (Control group) |
Patients will receive normal saline 20 ml loading
and 20 ml as infusion by intravenous route with the same rate as of dexmedetomedine till 90 minutes |
| Intervention |
Group D (Dexmedetomedine group) |
Patients will receive dexmedetomedine
infusion (loading: 0.5 microgram per kilogram and maintenance: 0.2 microgram per kilogram per hour by intravenous route) till 90 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients aged 18-60 years of either sex
-Body weight 40-80 kilogram
-ASA Grade first and second
-Patients scheduled for laproscopic surgery and who are willing to give
written and informed consent for general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Age less then 18 years and more then 60 years
2. ASA grade third and fourth
3. Patients not willing to participate in the study
4. Patients with a history of drug allergy
5. Patients with chronic pre-existing disease like Asthma, Renal or Hepatic
dysfunction, diabetes mellitus, neuro muscular diseases, severe
respiratory diseases etc.
6. Pregnancy/Lactation. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of perioperative iv dexmetadomidine on
haemodynamic |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pressor response due to laryngoscopy
2. Smooth extubation with maintaing haemodynamic stability
3. Side effects if any like hypotension, bradycardia, sedation
& various other side effects post operatively. |
Baseline to 90 min after induction of anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
22/02/2025 |
| 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="0"
Months="6"
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 aims to evaluate the effectiveness of intravenous dexmedetomidine infusion on intraoperative haemodynamics during laparoscopic surgeries. The study will be a prospective, double-blinded, randomized interventional study conducted at Jawaharlal Nehru Medical College and Associated Group of Hospitals, Ajmer.
The study will include 98 patients undergoing laparoscopic surgeries, randomly assigned to either a dexmedetomidine group or a control group. Dexmedetomidine will be administered intravenously as a bolus followed by an infusion, while the control group will receive normal saline.
The primary objective is to assess the impact of dexmedetomidine on haemodynamic parameters during various time intervals throughout the surgery. Secondary objectives include evaluating the drug’s effectiveness in reducing pressor response due to laryngoscopy, facilitating smooth extubation while maintaining haemodynamic stability, and observing any side effects like hypotension, bradycardia, or sedation.
The study’s findings will be analyzed using statistical methods to compare the haemodynamic response, sedation levels, and side effects between the two groups. The results will contribute to understanding the clinical benefits of dexmedetomidine for managing haemodynamic instability during laparoscopic surgeries and improving patient safety and recovery. |