| CTRI Number |
CTRI/2024/06/069387 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare the effect of two different drugs dexmedetomidine and fentanyl on quality of recovery using QoR15 score in patients undergoing laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Comparison of the effect of intravenous dexmedetomidine versus intravenous fentanyl on quality of recovery in patients undergoing laparoscopic cholecystectomy: A double blind randomized clinical 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 |
Garvita Singh Parmar |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai ,Etawah. |
| Address |
Room no.329,Department of Anaesthesiology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7049072166 |
| Fax |
|
| Email |
garvitasingh50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Shukla |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah. |
| Address |
Room no.329,Department of Anaesthesiology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9412201915 |
| Fax |
|
| Email |
ushashukla1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Shukla |
| Designation |
Professor and Head of Department of Anaesthesiology |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah. |
| Address |
Room no.329,Department of Anaesthesiology, Uttar Pradesh University of Medical Sciences, Saifai, Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9412201915 |
| Fax |
|
| Email |
ushashukla1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences, Department of Anaesthesiology ,Saifai,Etawah Uttarpradesh India PIN code - 206130 |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences Saifai Etawah |
| Address |
Room no.329 Department of Anaesthesiology and Critical care Uttar Pradesh University of Medical Sciences, Saifai, Etawah Uttarpradesh India PIN code -206130 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Garvita Singh Parmar |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah. |
Room no.329 Department of Anaesthesiology and Critical care Saifai, Etawah Uttarpradesh.
Etawah
UTTAR PRADESH |
7049072166
garvitasingh50@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteeUttar Pradesh University of Medical Sciences, Saifai, Etawah. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K82||Other diseases of gallbladder, (2) ICD-10 Condition: K80||Cholelithiasis, (3) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (4) ICD-10 Condition: K81||Cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine group |
Intravenous Dexmedetomidine 1 microgram per kg over 10 minutes before induction followed by 0.5 microgram per kg continuous infusion till the end of surgery. |
| Comparator Agent |
Fentanyl group |
Intravenous fentanyl 2microgram per kg over 10 minutes before induction followed by 0.5 microgram per kg continuous infusion till the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with body mass index between 18.5 to 24.9kg/m2.
2.American society of Anesthesiologists grade I and II.
3.Patients posted for laparoscopic cholecystectomy. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Known allergy to the drugs to be used.
3.Patients who are alcoholic or drug abuser.
4.Patients with body mass index greater than 30kg/m2.
5.Patients with clinically significant neurologic, psychiatric, cardiovascular, renal and hepatic diseases.
6.Patients who received an opioid analgesic medication within a 24 hour period before surgery.
7.Patients with upper respiratory tract infection, asthma, COPD.
8.Patients with chronic pain.
|
|
|
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 effect of intravenous dexmedetomidine versus intravenous fentanyl on quality of recovery using QoR 15 questionnaire. |
At 12 hours, 24 hours,36 hours, 48 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative pain using NRS (numeric pain rating scale). |
Just after surgery.
30 min after surgery.
1 hour after surgery.
2 hour after surgery.
6 hour after surgery. |
| To compare the total analgesic consumption in postoperative period. |
Just after surgery.
6hour after surgery.
12hour after surgery.
18hour after surgery.
24hour after surgery. |
| To compare change in hemodynamic parameters (blood pressure, mean arterial pressure, heart rate, saturation) in perioperative period. |
Baseline before induction.
5min, 10min, 30 min, 60 min intraoperatively.
At extubation.
5 minute after extubation.
10minute after extubation.
30minute after extubation. |
| Complications of any used drugs if any. |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/07/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This randomized, double-blind, control study will be conducted on 60 patients after the institutional ethical committee approves. The study will be carried out at our institute for over 12 months. Sampling will be done based on computer generated randomization, and allocation concealment will be done using a sealed, opaque envelope. Study medications will be prepared by anesthesiologists who will not be involved in further patient care or data collection. The anesthesiologist and post-anaesthesia care unit (PACU) nurse involved in data collection will not be aware of the groups.All the patients wil be randomly allocated into two groups of 30 each.Patients will be randomized into two groups: intervention drugs will be given to the patient according to group allocation10 minutes before induction then infusion will be continued till the end of surgery. Group B will receive IV Dexmedetomidine (1µg/kg over 10 min followed by 0.5µg/kg continuous infusion). Group A will receive IV fentanyl (2µg/ kg over 10 min followed by an infusion of 0.5 µg/kg/h). Intraoperative hemodynamic parameters like heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), saturation (%) will be continuously monitored throughout the surgery. Intraoperative adverse effects like bradycardia, hypotension, and arrhythmias will be noted and managed accordingly and Adverse drug reactions (ADR) reporting to the committee will be done in all cases. At the end of the surgery, intervention drugs infusion according to group allotment will be stopped. The patients will be then transferred to the post-anaesthesia care unit (PACU) and monitored for pain at 0, 30 min, 1hour, 2hour, and 6hour using an NRS Score.A pre-tested and pre-validated QoR-15 questionnaire will be used for the postoperative quality of recovery analysis at 12hour ,24hour, 36hour and 48 hours, patients will be asked to complete the QoR15 questionnaire in the post anaesthetic care unit (PACU). The questionnaire consists of 15 items, and the total sum of the scores ranged from 0 to 30. |