| CTRI Number |
CTRI/2025/06/089404 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Dexmedetomidine and Fentanyl for reducing Propofol use during laparoscopic abdominal surgery |
|
Scientific Title of Study
|
A randomized comparative study of propofol consumption for achieving adequate bispectral index using intravenous dexmedetomidine versus fentanyl in patients undergoing laparoscopic abdominal surgery under general anesthesia at SMS medical college jaipur |
| 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 Harpreet kaur |
| Designation |
Senior professor |
| Affiliation |
Sawai man singh medical college |
| Address |
Department of anaesthesia Sawai Man singh medical college and attached hospital jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Priyanka Singh |
| Designation |
Resident doctor |
| Affiliation |
Sawai man singh medical college |
| Address |
Department of anaesthesia Sawai Man singh medical college and attached hospital jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8871041948 |
| Fax |
|
| Email |
priy251019@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harpreet kaur |
| Designation |
Senior professor |
| Affiliation |
Sawai man singh medical college |
| Address |
Department of anaesthesia Sawai Man singh medical college and attached hospital jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia Sawai man singh medical college jaipur RAJASTHAN pin code 302004 India |
|
|
Primary Sponsor
|
| Name |
Sawai man singh medical college |
| Address |
Department of anaesthesia Sawai man singh medical college jaipur RAJASTHAN pin code 302004 India |
| 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 Harpreet kaur |
Sawai man singh medical college |
Department of anaesthesia Sawai man singh medical college
Jaipur
RAJASTHAN |
9899785993
rupihar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethics committe SMS medical college jaipur |
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 |
Dexmedetomidine |
1 mcg per kg intravenously |
| Intervention |
Fentanyl |
2 mcg per kg intravenously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective laparoscopic surgery under general anesthesia
Patients consenting to participate
Patients having ASA 1 and 2
Patients with mallampatti grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient with anticipated difficult bag and mask ventilation
Patient with known risk of aspiration
Patient with uncompensated cardiovascular pulmonary neurological hepatorenal and endocrine disorders |
|
|
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 |
Mean Propofol consumption using IV Dexmedetomidine to achieve BIS 50
Mean Propofol consumption using IV Fentanyl to achieve BIS 50
Mean time to achieve BIS 50 using IV Dexmedetomidine
Mean time to achieve BIS 50 using IV Fentanyl
|
At induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean hemodynamic parameters SBP DBP MAP HR SPO2 |
Baseline
After induction
Just after intubation
5 min
10 min
15 min
20 min
30 min
40 min
50 min
|
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="2"
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 randomized comparative study aimed to evaluate the effect of intravenous Dexmedetomidine versus intravenous Fentanyl on Propofol consumption required to achieve an adequate Bispectral Index (BIS) in patients undergoing laparoscopic abdominal surgeries under general anesthesia. Patients were randomly assigned to receive either Dexmedetomidine or Fentanyl as an adjunct to Propofol-based anesthesia. The primary outcome was the total Propofol requirement to maintain a target BIS level. Secondary outcomes included hemodynamic stability and recovery profiles. The study found that Dexmedetomidine significantly reduced Propofol consumption compared to Fentanyl, suggesting it as a more effective adjunct for BIS-guided anesthesia in this surgical context. |