| CTRI Number |
CTRI/2025/07/091908 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Between Fentanyl And Dexmedomidine Continuous Administration During Bispectral Index Guided Laparoscopic Cholecystectomy To Titre Desflurane Consumption To Reduce Sideeffects |
|
Scientific Title of Study
|
Comparison Between Fentanyl And Dexmedomidine Infusion On Desflurane Consumption During Bispectral Index Guided Laparoscopic Cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashima Sethi |
| Designation |
Junior Resident |
| Affiliation |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
| Address |
Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar
Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9914835253 |
| Fax |
|
| Email |
sethiashima53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanika Sachdeva |
| Designation |
Associate Professor |
| Affiliation |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
| Address |
Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar
Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9899440374 |
| Fax |
|
| Email |
kanikasachdeva17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashima Sethi |
| Designation |
Junior Resident |
| Affiliation |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
| Address |
Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar
Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar
UTTARANCHAL
248001
India |
| Phone |
9914835253 |
| Fax |
|
| Email |
sethiashima53@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences |
|
|
Primary Sponsor
|
| Name |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
| Address |
Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar Dehradun |
| 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 |
| Ashima Sethi |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
Department Of Anaesthesia Shri Mahant Inidresh Hospital Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar
Dehradun
UTTARANCHAL |
9914835253
sethiashima53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmetedomidine Infusion |
Loading dose 1 Microgram Per Kilogram Per Hour Followed by 0.5 Microgram Per Kilogram Per Hour Till Completion Of Surgery |
| Intervention |
Fentanyl Infusion |
1 Microgram Per Kilogram Per Hour |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade One And Two
Duration Of Surgery Should Not Be More Than 80 Minutes |
|
| ExclusionCriteria |
| Details |
Emergency Cases
Laparoscopy Converted To Open Cholecystectomy Intraoperatively |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Calculate And Compare Desflurane Consumption When Combined With Fentanyl And Dexmedetomidine Infusion Guided By Bispectral Index |
Anaesthesia Induction To Extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative Heart Rate And Blood Pressure Changes In Both groups |
Anaesthesia Induction To Extubation |
| Drug Related Complications In Both Groups |
Anaesthesia Induction To Extubation |
|
|
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 4 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kanika.mamgain@gmail.com].
- For how long will this data be available start date provided 01-04-2026 and end date provided 01-04-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Comparison Of Infusion Fentanyl And Dexmedetomidine Will Be Done To Evaluate The Consumption Of Desflurane Maintaining Adequate Depth Of Anaesthesia Guided by Bispectral Index Monitoring In Patients Coming To Shri Guru Ram Rai Institute Of Medical And Health Sciences Coming For Elective Laparoscopic Cholecystectomy. The Primary Goal Of Study Is Desflurane Consumption And Secondary Aim Is To Evaluate Safety Profile Of Study Drugs In Parameters Of Vitals And Drug Related Complications. |