| CTRI Number |
CTRI/2023/07/055781 [Registered on: 27/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
COMPARISON BETWEEN DEXMEDETOMIDINE
AND PROPOFOL INFUSION IN MAINTAINING
HAEMODYNAMIC STABILITY DURING
PNEUMOPERITONEUM IN PATIENTS
UNDERGOING LAPAROSCOPIC
CHOLECYSTECTOMY |
|
Scientific Title of Study
|
COMPARISON BETWEEN DEXMEDETOMIDINE
AND PROPOFOL INFUSION IN MAINTAINING
HAEMODYNAMIC STABILITY DURING
PNEUMOPERITONEUM 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 Rahul M |
| Designation |
Junior Resident |
| Affiliation |
K.S HEGDE MEDICAL ACADEMY |
| Address |
Department of anaesthesia and critical care, KS Hegde Medical Academy, Mangalore
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
919164766643 |
| Fax |
|
| Email |
rahulchintamani1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananda Bangera |
| Designation |
Professor |
| Affiliation |
K.S HEGDE MEDICAL ACADEMY |
| Address |
Department of Anaesthesia and Critical care , K S Hegde Medical Academy , Mangalore
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
9845278880 |
| Fax |
|
| Email |
anandabangera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul M |
| Designation |
Junior Resident |
| Affiliation |
K.S HEGDE MEDICAL ACADEMY |
| Address |
Department of anaesthesia and critical care , KS Hegde Medical Academy, Mangalore
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
919164766641 |
| Fax |
|
| Email |
rahulchintamani1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy |
|
|
Primary Sponsor
|
| Name |
KS Hegde Medical Academy |
| Address |
Department of anaesthesia and critical care, KS Hegde Medical Academy Mangalore |
| 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 Rahul M |
K S Hegde Medical Academy |
Deralakatte , mangalore
Dakshina Kannada
KARNATAKA |
918660982184
rahulchintamani1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S Hegde medical acedemy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine group |
From intubation till desufflatiom of pneumoperitoneum |
| Comparator Agent |
Propofol group |
From intubation till desufflatiom of pneumoperitoneum |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patient with known allergy to study drug
Pregnancies
Patient who will be converted from laparoscopic cholecystectomy to open cholecystectomy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of dexmedetomidine with propofol in maintaining the haemodynamic response to pneumoperitoneum during laparoscopic cholecystectomy |
upto 2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the haemodynamics of dexmedetomidine & propofol regarding -Time to extubate , haemodynamics during extubation |
Four hours |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
10/08/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the effectiveness of dexmedetomidine with propofol in maintaining the haemodynamic response to pneumoperitoneum during laparoscopic cholecystectomy |