| CTRI Number |
CTRI/2024/07/070420 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of dexmedetomidine and lidocaine infusion for postoperative analgesia in open cholecystectomy |
|
Scientific Title of Study
|
Comparative evaluation of dexmedetomidine and lidocaine in postoperative analgesia in open cholecystectomy a double blind study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamal Jyoti Kashyap |
| Designation |
Associate professor |
| Affiliation |
Government medical College Amritsar |
| Address |
Office of associate professors, Anaesthestia department,Main OT complex , Government Medical College, Amritsar , Anaesthesia department
Amritsar
PUNJAB
143001
India |
| Phone |
9878883727 |
| Fax |
|
| Email |
gauryanheerak@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Jyoti Kashyap |
| Designation |
Associate professor |
| Affiliation |
Government medical College Amritsar |
| Address |
Room of associate professors, Anaesthestia department, Main OT complex , Government Medical College, Amritsar , Anaesthesia department
Amritsar
PUNJAB
143001
India |
| Phone |
9878883727 |
| Fax |
|
| Email |
gauryanheerak@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Sabharwal |
| Designation |
Junior resident, ANAESTHESIA DEPARTMENT |
| Affiliation |
Government medical College Amritsar |
| Address |
Room no. 31 , Boys hostel , D block , Government medical College Amritsar
GOVERNMENT MEDICAL COLLEGE AMRITSAR Medical Enclave
SR quaters
Amritsar
PUNJAB
143001
India |
| Phone |
6239628950 |
| Fax |
|
| Email |
vsabharwal99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical College , Amritsar , Punjab , India 143001 |
|
|
Primary Sponsor
|
| Name |
Dr Kamal Jyoti Kashyap |
| Address |
Room of associate professors , Department of Anaesthesiology and Intensive
Care Government Medical College Amritsar
Amritsar PUNJAB 143001 India |
| Type of Sponsor |
Other [Self ] |
|
|
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 Vivek Sabharwal |
MAIN SURGERY OPERATION THEATRE COMPLEX |
Department of
Anaesthesia , Division-
Main Surgery OT
Complex, Room- Table
A and Table B
Government medical
College Amritsar
143001
Amritsar
PUNJAB
Amritsar
PUNJAB |
6239628950
vsabharwal99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College,Amritsar |
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 |
| Intervention |
Perioperarive infusion of Dexmedetomidine in open cholecystectomy under general anaesthesia |
Post operative pain (VAS score ) , haemodynamic parameters
and requirements of rescue analgesia will be noted and will be compared with other groups. |
| Comparator Agent |
Perioperarive Lignocaine iv infusion in open cholecystectomy under general anaesthesia |
Post operative pain (VAS score ) , haemodynamic parameters
and requirements of rescue analgesia will be noted and will be compared with other groups. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
age 20-60 years ,American Society of Anaesthesiologists (ASA) grade I and II ,
posted for open cholecystectomy under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Allergy to study drugs , obesity (BMI more than 35), renal failure , liver failure , pregnancy, alcohol abuse , chronic use of analgesic or other drugs , decreased autonomic control ,malampatti grade III and IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue scale (VAS) scores at various time intervals, haemodynamic changes |
hemodynamic parameters will be assesd during intraoperative period and Visual Analogue scale (VAS score) , hemodynamic parameter and requirements of rescue analgesia will be assesd post operative period for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sedation score , time taken to achieve MPADSS ( Modified post anaesthestia discharge scoring system), time required for additional analgesia, measure requirements of rescue analgesia, total analgesic requirements in 24 hrs |
From end of surgery till 24 hours postoperative |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/07/2024 |
| 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="0"
Months="2"
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
|
Gallstone disease (cholelithiasis) is a major health problem in adult population. Open cholecystectomy is routinely performed in elective operation theatres. Postoperative pain is major cause of morbidity in postoperative period and it affects multiple organ systems. This study is designed to evaluate the effects of intravenous infusion of dexmedetomidine vs lidocaine for postoperative analgesia. Double blind randomized study will be performed on 80 patients with age 20-60 years ASA (American Society of Anaesthesiologist) grade I and II for open cholecystectomy under general anaesthesia. Patients in group L will receive Intravenous lidocaine 1.5mg/kg body weight followed by Infusion of 2mg/kg/hr. In group D, patients will receive 1mcg/kg dexmedetomidine followed by infusion of 0.4mcg/kg/hr. Patients will be kept in post anaesthesia care unit (PACU) for 24 hrs and pain will be assessed at regular intervals using visual analogue scale (VAS). Vitals will also be monitored at regular intervals. Post operative consumption of diclofenac and tramadol will be noted.The data will then be compiled, tabulated and statistically analyzed with latest software.
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