| CTRI Number |
CTRI/2024/05/068122 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare intra operative intravenous Dexmemeditomine versus Fentanyl
for attenuating hemodynamic response in laproscopic cholecystectomy. |
|
Scientific Title of Study
|
Comparison of intra operative intravenous dexmedetomidine versus fentanyl for attenuating hemodynamic response in laparoscopie cholecystectomy randomized interventional study in the department of anaesthesiology sms medical college and attached group of hospitals |
| 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 ChandraShekhar Chatterjee |
| Designation |
Senior professor |
| Affiliation |
sms medical college |
| Address |
HOD office, Department of anaesthesiology, second floor, dhanvantri complex, sms medical college, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828088092 |
| Fax |
|
| Email |
chatterjee.chandrashekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ChandraShekhar Chatterjee |
| Designation |
Senior professor |
| Affiliation |
sms medical college |
| Address |
HOD Office, Department of anaesthesiology, second floor, dhanvantri complex, sms medical college, jaipur
RAJASTHAN
302004
India |
| Phone |
9828088092 |
| Fax |
|
| Email |
chatterjee.chandrashekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Virendra Singh Meena |
| Designation |
Junior resident |
| Affiliation |
SMS Medical College |
| Address |
HOD Office, Department of anaesthesiology, second floor, dhanvantri complex, sms medical college, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9460987080 |
| Fax |
|
| Email |
dr.virendrasinghmeena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Second floor Dhanvantari complex SMS Medical college Jaipur 302004 rajasthan india |
|
|
Primary Sponsor
|
| Name |
SMS Medical college and hospital |
| Address |
Department of anaesthesiology second floor dhanvantari complex sms hospital jaipur 302004 rajasthan india |
| 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 Chandrashekhar Chatterjee |
SMS Medical college and attached hospitals |
HOD Office Department of anaesthesiology second floor dhanvantri complex sms medical college jaipur
Jaipur
RAJASTHAN |
9828088092
chatterjee.chandrashekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical college Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Dexmedetomidine |
Patients will receive intravenous 0.5 μg/kg of the Dexmedetomidine as
loading dose over 10 minutes prior to intubation followed by 0.2-0.7 μg/kg/hr as infusion of the Dexmedetomidine till the surgery will be over |
| Comparator Agent |
Intravenous fentanyl |
Patients will receive intravenous 0.5 μg/kg of the Fentanyl as loading
dose over 10 minutes prior to intubation followed by 0.2-0.7 μg/kg/hr as infusion of the Fentanyl till the surgery will be over |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I & II
BMI: 18.5 to 25
Patients bodyb weight 40-70 kgs
Undergoing elective laproscopic cholecystectomy
Patients willing to give consent |
|
| ExclusionCriteria |
| Details |
Patients allergic to the study drugs
Patients with anticipated difficult airway and laryngoscopytime more than 30 seconds
Patients on beta blocker
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the hemodynamic variation from baseline in both the groups in terms
of difference in mean HR at different time intervals.
|
0 BASE line
10 minutes after the study drug
After inj. Of induction drug
Immediately After intubation
1min after intubation
2min after intubation
5min after intubation
Immediately after pneumoperitoneum
1min
5min
15min
30min
60 min
5 min after release of pneumoperitoneum
Immediately post extubation
1 min
2 min
5 min
10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO DETERMINE CHANGE IN SBP DBP ETCO2 serum cortisol in response to pneumoperitonium |
10 min before surgery to 5 min post extubation |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 4 |
|
Date of First Enrollment (India)
|
11/06/2024 |
| 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="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
|
Our aim is to compare intra operative intravenous Dexmedetomidine versus Fentanyl for attenuating hemodynamic response in laparoscopic cholecystectomy by monitoring various parameters |