| CTRI Number |
CTRI/2025/05/086759 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Dexmedetomidine and Lidocaine for Better post operative analgesia undergoing lap cholecystectomy |
|
Scientific Title of Study
|
A Comparative Study to See the Effect of Perioperative Infusion of Dexmedetomidine
Vs Lidocaine on Haemodynamic Response and Post-Operative Analgesia in Patients Undergoing
Laparoscopic Cholecystectomy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kapil Yadav |
| Designation |
Resident anesthesiology |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anesthesiology and critical care, 3rd floor pacific medical college and hospital,Bhillon Ka Bedla, Udaipur, Rajasthan
RAJASTHAN
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9896464499 |
| Fax |
|
| Email |
Kapil99yadava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Goyal |
| Designation |
Professor - Department of Anesthesia |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anaesthesia, Pacific Medical College and Hospital, Bhilon ka Bedla, N.H. 27, Pratap Pura, Girwa, Udaipur, Rajasthan 313001, India
Udaipur
RAJASTHAN
313001
India |
| Phone |
8890802830 |
| Fax |
|
| Email |
sameergoy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer Goyal |
| Designation |
Professor - Department of Anesthesia |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anaesthesia, Pacific Medical College and Hospital, Bhilon ka Bedla, N.H. 27, Pratap Pura, Girwa, Udaipur, Rajasthan 313001, India
Udaipur
RAJASTHAN
313001
India |
| Phone |
8890802830 |
| Fax |
|
| Email |
sameergoy@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology and critical care, 3rd floor, Pacific Medical College and Hospital, Udaipur, Rajesthan- 313001 |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College and Hospital |
| Address |
Pacific Medical College and Hospital, Bhilon ka Bedla, N.H. 27, Pratap Pura, Girwa, Udaipur, Rajasthan 313001 |
| 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 Kapil Yadav |
Pacific Medical College and Hospital, Udaipur |
Pacific Medical College and Hospital, Department of anesthesiology and critical care,3rd floor, Bhilon ka Bedla, Udaipur, Rajasthan 313001
Udaipur
RAJASTHAN |
9896464499
kapil99yadava@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pacific Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Infusion of injection Dexmedetomidine |
IV Dexmedetomidine diluted in 50ml Normal saline at loading dose 1mcg/kg infusion over 15 min before laryngoscopy followed by a maintenance dose of 0.6mcg/kg/hr. |
| Comparator Agent |
Preservative-free injection Lidocaine 2% |
Preservative-free injection Lidocaine 2% diluted to a volume of 50ml normal saline at loading dose 2mg/kg over 15 minutes before laryngoscopy followed by an infusion of 2mg/kg/hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient giving informed consent.
2. Patients planned for laproscopic colecystectomy between age 18 to 60 years of either gender.
3. ASA Grade I and II.
4. Weight between 45kgs-75kgs. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. ASA Grade III or IV.
3. Patient who are allergic to study drugs.
4. Pregnant or lactating female.
5. Patient with known history of substance abuse.
6. Hepatic, cardiovascular, renal, heamatological, neuromuscular disorder.
7. Patients with airway problems.
8. Those in whom procedure had to be converted to open cholecystectomy. |
|
|
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 |
Through this study we will be able to know
whether infusion of Dexmedetomidine or lidocaine is having better heamodynamic responses and post operative analgesia in patients undergoing laproscopic cholecystectomy. |
24 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To document any adverse effect |
24 months. |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
22/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A prospective double blind trail, to compare the effects of perioperative infusion of dexmedetomidine and lidocaine on hemodynamic response and post-operative analgesia in patients undergoing laparoscopic cholecystect |