| CTRI Number |
CTRI/2024/03/064843 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of amisulpride versus dexamethasone for control of nausea and vomiting after laparoscopic gall bladder removal operation. |
|
Scientific Title of Study
|
Efficacy of amisulpride versus dexamethasone for post operative nausea and vomiting prophylaxis in patients undergoing laparoscopic cholecystectomy- a randomized controlled trial. |
| 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 Amit Pradhan |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Kalinga Institute of Medical Sciences,KIIT DEEMED TO BE UNIVERSITY, BHUBANESWAR,Khordha ,Odisha
Khordha
ORISSA
751024
India |
| Phone |
9437191002 |
| Fax |
|
| Email |
amitpdear@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna Das |
| Designation |
Assistant Professor |
| Affiliation |
KIMS, Bhubaneswar |
| Address |
Department of Anaesthesiology,
Kalinga Institute of Medical Sciences ,KIIT DEEMED TO BE UNIVERSITY, BHUBANESWAR,Khordha ,Odisha
Khordha
ORISSA
751024
India |
| Phone |
9078826164 |
| Fax |
|
| Email |
dr.sapnadas88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K B Tharun Kumar |
| Designation |
Anaesthesiology junior resident |
| Affiliation |
KIMS, Bhubaneswar |
| Address |
Department of Anaesthesiology,
Kalinga Institute of Medical Sciences ,KIIT DEEMED TO BE UNIVERSITY, BHUBANESWAR,Khordha ,Odisha
Khordha
ORISSA
751024
India |
| Phone |
7097091129 |
| Fax |
|
| Email |
kbtk786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Amit Pradhan |
| Address |
Department of Anaesthesiology,
Kalinga Institute of Medical Sciences,KIIT Deemed to be University,Bhubaneswar,Khordha,Odisha Pin-751024 India |
| Type of Sponsor |
Other [self] |
|
|
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 K B Tharun Kumar |
PBMH,Kalinga Institute of Medical Sciences |
Department of Anaesthesiology ,Kalinga Institute of Medical Sciences ,Bhubaneswar, Khordha ,Odisha pin-751024
Khordha
ORISSA |
7097091129
kbtk786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCES |
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 |
Amisulpride |
Group A- will receive 5mg of Amisulpride
|
| Comparator Agent |
Dexamethasone |
Group D- will receive 8mg of Dexamethasone
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1& 2
Patients posted for elective Laparoscopic cholecystectomy under endotracheal general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Any hypersensitivity to the study drugs
2.Administration of antiemetic/steroid 24 hrs prior to anaesthesia
3.Administration of Emetogenic anticancer chemotherapy in previous 4 weeks
4.Pregnant/lactating females
5.Patients on treatment with levodopa/ carbidopa
6.Cardiac arryhthmia, QT interval abnormality
7.Hypokalemia,hypomagnesemia
8.Pre-existing vestibular disease
9.Need of naso/oro-gastric tube after surgery
10.Requirement of post operative mechanical ventilation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the proportion of Complete Response(defined as no episodes of nausea, retching or vomiting) upto first 24 hours after surgery |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Incidence and severity of significant nausea
2 Incidence of retching or vomiting
3 Time to first requirement of rescue antiemetic
4 Number of times of requirement of rescue antiemetic
5 VAS Score for pain
6 Adverse effects like infusion site pain, constipation and flatulence
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="2"
Months="0"
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
|
Dexamethasone has been widely used to prevent nausea and vomiting. Amisulpride is recently shown to be effective in preventing vomiting. So we want to compare the efficacy of amisulpride versus dexamethasone in preventing post operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy under general anaesthesia. PRIMARY OBJECTIVE : To compare the efficacy of Amisulpride versus Dexamethasone in prevention of post operative nausea and vomiting
SECONDARY OBJECTIVES:To compare the adverse effects in both the study groups.
|