| CTRI Number |
CTRI/2022/11/047103 [Registered on: 07/11/2022] Trial Registered Prospectively |
| Last Modified On: |
07/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A scientific experiment to study the effects of the drug Ropivacaine with two additives, Clonidine and Dexmedetomidine, instilled inside abdomen in patients undergoing elective laparoscopic cholecystectomy |
|
Scientific Title of Study
|
A prospective randomized double blind control study comparing the analgesic efficacy of intraperitoneal Ropivacaine with Dexmedetomidine and Ropivacaine with Clonidine in patients undergoing elective laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyadarshini Kalahasthi |
| Designation |
MBBS |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Mysore Medical College and Research Institute, Irwin Road, Mysuru
Mysore
KARNATAKA
570001
India |
| Phone |
8825847078 |
| Fax |
|
| Email |
kpriya91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashikala TK |
| Designation |
Professor |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Mysore Medical College and Research Institute, Irwin Road, Mysuru
Mysore
KARNATAKA
570001
India |
| Phone |
9148650639 |
| Fax |
|
| Email |
drshi72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyadarshini Kalahasthi |
| Designation |
MBBS |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Mysore Medical College and Research Institute, Irwin Road, Mysuru
Mysore
KARNATAKA
570001
India |
| Phone |
8825847078 |
| Fax |
|
| Email |
kpriya91@gmail.com |
|
|
Source of Monetary or Material Support
|
| KR Hospital, Irwin Road, Devaraja Mohalla, Yadavagiri, Mysore, Karnataka - 570001 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Mysore Medical College and Research Institute, Mysuru, Karnataka - 570001 |
| 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 |
| Priyadarshini Kalahasthi |
Surgery stone building, KR Hospital |
Irwin Road, Devaraja Mohalla, Yadavagiri, Mysuru
Mysore
KARNATAKA |
8825847078
kpriya91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Group R |
Intraperitoneal instillation of 40ml 0.25% Ropivacaine plus 5ml NS |
| Intervention |
Group RC |
Intraperitoneal instillation of 40ml 0.25% Ropivacaine plus 1mcg/kg Clonidine in 5ml NS |
| Intervention |
Group RD |
Intraperitoneal instillation of 40ml 0.25% Ropivacaine plus 1mcg/kg Dexmedetomidine in 5ml NS |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All ASA grade I and grade II patients between 19-60 years age group |
|
| ExclusionCriteria |
| Details |
· All ASA grade III and IV patients.
· Diabetes and Hypertension.
· Cardiovascular, respiratory and neurological disorders.
· Obesity (BMI>30kg/m2).
· Drug allergy
|
|
|
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 |
Numerical Rating Score (NRS)
Time for first request of analgesia |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects |
24 hours |
| Patient satisfaction |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
21/11/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective randomized double-blind control study comparing the analgesic efficacy of Ropivacaine with a2 agonist adjuvants for intraperitoneal instillation in patients undergoing laparoscopic cholecystectomy in KR Hospital |