| CTRI Number |
CTRI/2024/11/077401 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Recovery Process in Patients Who Receive Either Dexmedetomidine or Remifentanil During Laparoscopic Gallbladder Surgery |
|
Scientific Title of Study
|
Comparative Study Of Recovery Characteristics Using Intraoperative Dexmedetomidine With Remifentanil In Patients Undergoing Elective Laparoscopic Cholecystectomy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1315-3858 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr subidhi devadiya |
| Designation |
Junior resident |
| Affiliation |
teerthanker mahaveer medical college and research centre |
| Address |
Department of anaesthesia,Teerthanker mahaveer medical college and research centre,delhi road, moradabad up, 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9630976086 |
| Fax |
|
| Email |
Subidhi.devadiya000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi ahluwalia |
| Designation |
professor |
| Affiliation |
teerthanker mahaveer medical college and research centre |
| Address |
Department of anaesthesia,Teerthanker mahaveer medical college and research centre,delhi road, moradabad up, 244001
anaesthesia,Teerthanker mahaveer medical college and research centre,delhi road, moradabad up, 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8218628850 |
| Fax |
|
| Email |
pallaviahluwalia22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi ahluwalia |
| Designation |
professor |
| Affiliation |
teerthanker mahaveer medical college and research centre |
| Address |
Department of anaesthesia,Teerthanker mahaveer medical college and research centre,delhi road, moradabad up, 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8218628850 |
| Fax |
|
| Email |
pallaviahluwalia22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker mahaveer medical college and research centre, moradabad UP, 244001 INDIA |
|
|
Primary Sponsor
|
| Name |
Teerthanker mahaveer medical college and research centre, |
| Address |
Teerthanker mahaveer medical college and research centre,delhi road, moradabad UP, 244001 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 Subidhi devadiya |
Teerthanker mahaveer mahaveer medical college and research centre |
Department of anaesthesia,Teerthanker mahaveer medical college and research centre,delhi road, moradabad up, 244001
Moradabad
UTTAR PRADESH |
09630976086
Subidhi.devadiya000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teethanker mahaveer university-institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexemedetomidine |
Loading dose 1mcg/kg followed by infusion infusion dose 0.5mcg/mg/min via IV route
duration-0min,5min,10min,15min,20min,25min,30 min and every 5 min till the end of procedure. |
| Intervention |
Remifentanyl |
loading dose 1mcg/kg followed by infusion dose 0.5mcg/kg/min via IV route
duration-0min,5min,10min,15min,20min,25min,30 min and every 5 min till the end of procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for Elective Laparoscopic Cholecystectomy.
Patient giving written and informed consent.
American Society of Anesthesiologist (ASA) physical status I-II
Age group of 18-60 years old.
BMI 18.5kg/m2 to 24.9kg/m2
|
|
| ExclusionCriteria |
| Details |
Patient history of allergy to opioids, alpha-2 receptor drugs.
History of alcohol and drug abuse.
Pregnant patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare recovery characteristics like Richmond Agitation sedation scale(RASS)
To compare Pain using Numerical rating score(NRS) in both the groups.
To compare time from post anaesthesia care unit to ward in both the groups.
|
0mins,15mins,30mins,45min,1hour,2hour,4hour,8hour,12hour,16hour,20hour,24hour
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare hemodynamics parameters in both the groups.
To compare total post operative analgesic consumption in both the groups.
To compare complications in both the groups |
0mins,15mins,30mins,45min,1hour,2hour,4hour,8hour,12hour,16hour,20hour,24hour
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
After getting approval from college research committee[CRC] AND Institutional ethical committee[IEC],those patients meeting the inclusions criteria will be enrolled
Randomization will be done by computer generated random random table number and 80 patients will be assigned into two groups, Group DM and Group RF, 40 patients in each group.
Group DM : Dexemedetomidine loading dose 1mcg/kg followed by infusion dose 0.5mcg/kg/hr Group RF : remifentanyl loading dose 1mcg/kg followed by infusion dose 0.5mcg/kg/min
Induction of anaesthesia and tracheal intubation of anaesthesia will be used as per patient characteristics and institutional protocol
Intraoperative monitoring [HR,SBP,DBP,MAP,PR,PI,SPO2] will be done as per instuitional protocol.
After Extubation, patients will be shifted post anaesthesia care unit
After they achieved Aldrete score [<9], then shift the patients PACU to ward
NRS SCORE : MEASURED 1ST 30mins and hourly for the first 2hours and then at 4hourly interval till 24hour
All pre operative and post operative data collected will be analyzed
|