| CTRI Number |
CTRI/2019/03/017963 [Registered on: 07/03/2019] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| 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
|
Comparison between intraperitoneal ropivacaine alone and with Dexmedetomidine in laproscopic cholecystectomy |
|
Scientific Title of Study
|
A comparative evaluation of intraperitoneal instillation of ropivacaine alone or with dexmedetomidine for postoperative analgesia following laproscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena mathur |
| Designation |
Senior professor |
| Affiliation |
J.L.N. medical college ajmer |
| Address |
Department of Anasthesia Jln medical college Ajmer
Rajasthan
305001
India
Ajmer
RAJASTHAN
305001
India |
| Phone |
|
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena mathur |
| Designation |
Senior professor |
| Affiliation |
J.L.N. medical college ajmer |
| Address |
Department of Anasthesia Jln medical college Ajmer
Rajasthan
305001
India
Ajmer
RAJASTHAN
305001
India |
| Phone |
|
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena mathur |
| Designation |
Senior professor |
| Affiliation |
J.L.N. medical college ajmer |
| Address |
Department of Anasthesia Jln medical college Ajmer
Rajasthan
305001
India
Ajmer
RAJASTHAN
305001
India |
| Phone |
|
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology jawahar lal nehru medical medical college Ajmer |
|
|
Primary Sponsor
|
| Name |
Jln medical college Ajmer |
| Address |
Department of Anaesthesia, JLN Medical College Ajmer Rajasthan |
| 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 |
| Dr Priyanka Soni |
JLN Medical College Ajmer |
Department of Anaesthesiology jawahar lal nehru medical college Medical College Ajmer
Ajmer
RAJASTHAN |
8005708914
drpriyankasoni0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee JLN Medical College Ajmer |
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 |
| Intervention |
Intraperitoneal instillation of drug following laproscopic cholecystectomy |
For postoperative analgesia |
| Comparator Agent |
Ropivacaine alone and with Dexmedetomidine |
For duration of analgesia and hemodynamic changes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 18 years to 60 years of both sex undergoing laparascopic cholecystectomy.
2.Patients belonging to ASA (American Society of Anaesthesiologists) grade-I and grade-II.
3.Gall Bladder calculi or polyp with no evidence of acute cholecystitis at the time of surgery. |
|
| ExclusionCriteria |
| Details |
1.Age less than 18 year of age or more than 60 year of age
2.ASA grade III or more (American Society of Anaesthesiology)
3.Pregnancy
4.Acute Cholecystitis
5.Choledocolithiasis
6.Conversion of laparascopic cholecystectomy to open cholecystectomy.
7.patient who are allergic study drug,severe cardiac disease ,pulmonary disease, neurological disease
patients in whom abdominal drain was put |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The intensity of post‑operative pain was recorded for all the cases using VAS score after surgery
Comaprison of effect in the patients between ropivacine alone and ropivacine with dexmedetomidine |
Duration of the study is around 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total amount of rescue analgesic in 24 hours
Haemodynamic change
Any side effects |
Duration of study around 1 year. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2019 |
| Date of Study Completion (India) |
30/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To assess the efficacy and safety of addition of dexmedetomidine to 0.25% ropivacaine used for intraperitoneal instillation on postoperative analgesia in patients undergoing laparoscopic cholecystectomy.
Primary objectives Duration of analgesia (from the time of extubation to the demand of first dose of rescue analgesic) Secondary objectives Total amount of rescue analgesic required in 24 hours Haemodynamic changes Adverse effects, if any |