| CTRI Number |
CTRI/2024/09/073195 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
to know the effect of using new drug on nause and vomiting in patients undergoing surgery |
|
Scientific Title of Study
|
A study of anti-emetic efficacy of dexmedetomidine in patients undergoing laparoscopic cholecystectomy surgeries under general anesthesia |
| 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 Hema k |
| Designation |
Postgraduate student |
| Affiliation |
ESIC MC PGIMSR MH RAJAJINAGAR BANGALORE |
| Address |
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
Bangalore
KARNATAKA
560097
India |
| Phone |
08660272539 |
| Fax |
080-23325130 |
| Email |
hemakreddy4503@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUMALATHA G B |
| Designation |
Professor |
| Affiliation |
ESIC MC PGIMSR MH RAJAJINAGAR BANGALORE |
| Address |
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
Bangalore
KARNATAKA
560086
India |
| Phone |
08660272539 |
| Fax |
080-23325130 |
| Email |
gbsumaravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G B Sumalatha |
| Designation |
Professor |
| Affiliation |
ESIC MC PGIMSR MH RAJAJINAGAR BANGALORE |
| Address |
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
EESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
Bangalore
KARNATAKA
560086
India |
| Phone |
08660272539 |
| Fax |
080-23325130 |
| Email |
gbsumaravi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Employees State Insurance Corporation Medical College Bangalore |
| Address |
ESIC Postgraduate Insitute of Medical Science and research Rajajinagar Bangalore operation theatre complex Anaesthesiology department third floor |
| 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 G B SUMALATHA |
ESIC MC PGIMSR OPERATION THEATRE COMPLEX |
ESIC Postgraduate Institue of Medical Sciences and Medical Hospital. 3rd floor. Operation theatre complex. Department of Anesthesiology
Bangalore
KARNATAKA |
09538301444
080-23325130
gbsumaravi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Letter Head of EC approval |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: PCS||, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
injection dexmedetomidine |
0.75mcg/kg infusion over 10minutes in 100 ml saline before start of surgery . The infusion is given only during the surgery. |
| Comparator Agent |
normal saline |
normal saline infusion before the start of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient who are willing to give informed written consen
Patients of American society of Anesthesiologists (ASA) physical status class I –II
Patient of either gender, aged between 18-60 years.
Elective laparoscopic cholecysectomy surgeries under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patient with history of post operative nausea and vomiting.
Patient with history of motion sickness.
Patient with cardiac , renal and hepatic dysfunction.
including corticosteroids
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of dexmedetomidine infusion in a dose of 0.75mcg/kg started after induction of anaesthesia on post operative nausea and vomiting in patients undergoing laparoscopic cholecysectomy surgery under general anaesthesia. |
T - 1 - one hour post surgery
t 2 -2 hour post surgery
t3 - 4 hr post surgery
t 4 - 24 hour post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the severity of vomiting at after24 hour of surgery |
t 2 - post operative 24 hour |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
13/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
postoperative nausea and vomiting is unpleasant condition after general an aesthesia. the incidence is more after laparoscopic surgeries. hence injection dexmedetomidine can reduce the incidence and severity of vomiting in such patients . |