| CTRI Number |
CTRI/2025/07/090277 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to see the effect of medicine called Dexmedetomidine in patients undergoing gallbladder removal surgery |
|
Scientific Title of Study
|
The effectiveness of intravenous Dexmedetomidine on perioperative Hemodynamics, Analgesics requirement and Side-effects profile in patients undergoing Laparoscopic cholecystectomy under General Anaesthesia an Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayyad Muzzammil magbul |
| Designation |
Junior resident |
| Affiliation |
Vilasrao Deshmukh Government Medical College latur |
| Address |
Room 224 new pg hostel Vilasrao Deshmukh Government Medical College gandhi chowk latur
Latur
MAHARASHTRA
413512
India |
| Phone |
808150942 |
| Fax |
|
| Email |
muzzammilsayyad0202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shailendra Dattusing chauhan |
| Designation |
Professor and head of Department |
| Affiliation |
Vilasrao Deshmukh Government Medical College latur |
| Address |
Shrikrishnanagar vrindavan colony ausa road latur
Latur
MAHARASHTRA
413512
India |
| Phone |
7586693032 |
| Fax |
|
| Email |
Shailendradc@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shailendra Dattusing chauhan |
| Designation |
Professor and head of Department |
| Affiliation |
Vilasrao Deshmukh Government Medical College latur |
| Address |
Shrikrishnanagar vrindavan colony ausa road latur
MAHARASHTRA
413512
India |
| Phone |
7586693032 |
| Fax |
|
| Email |
Shailendradc@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Vilasrao Deshmukh Government Medical College gandhi chowk latur 413512
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Vilasrao Deshmukh Government Medical College latur |
| Address |
Department of Anaesthesia second floor surgical building vdgmc latur
413512
Maharashtra |
| 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 Muzzammil sayyad magbul |
Vilasrao Deshmukh Government Medical College latur |
Department of Anaesthesia secondfloor surgical building vdgmc NearRajasthan Marwadi School GandhiChowk Old Railway Station Latur413512 Maharashtra
Latur
MAHARASHTRA |
8087150942
muzzammilsayyad0202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Vilasrao Deshmukh Government Medical College latur |
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 |
Dexmedetomidine |
Intravenous Dexmedetomidine Infusions will be started perioperatively as per weight of patients |
| Comparator Agent |
Nil |
Standar care will be given no Dexmedetomidine will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing Laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patients Undergoing open cholecystectomy
Patients with contraindication to study drug |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in perioperative hemodynamic parameters heart rate, blood pressure in patients receiving intravenous Dexmedetomidine during laparoscopic cholecystectomy under general anesthesia |
Changes in perioperative hemodynamic parameters heart rate, blood pressure in patients receiving intravenous Dexmedetomidine during laparoscopic cholecystectomy under general anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
15/07/2025 |
| 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="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
|
This study aims to evaluate the effect of intravenous Dexmedetomidine on heart rate, blood pressure, painkiller requirements, and side effects in patients undergoing laparoscopic gallbladder removal under general anesthesia. It is a prospective observational study comparing outcomes with and without Dexmedetomidine |