| CTRI Number |
CTRI/2023/11/060178 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
21/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing two techniques of reducing vomiting after operation for removal of gall bladder by micro surgery where one technique is using a drug only and the other technique is using both drug and saline |
|
Scientific Title of Study
|
DEXAMETHASONE VERSUS
DEXAMETHASONE PLUS INTRAOPERATIVE
INTRAVENOUS RINGER LACTATE (30ML/KG)
INFUSION TO PREVENT POSTOPERATIVE
VOMITING IN PATIENTS UNDERGOING
LAPAROSCOPIC
CHOLECYSTECTOMY;RANDOMISED,
DOUBLE BLINDED 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 |
Dr Kuldip Batabyal |
| Designation |
Post Graduate Trainee |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College and Hospital, Vidyasagar Road, Midnapore Town, Paschim Medinipur, West Bengal, Pin - 721101
Medinipur
WEST BENGAL
721101
India |
| Phone |
7908000122 |
| Fax |
|
| Email |
kuldipbatabyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bijoy Kumar Bandyopadhyay |
| Designation |
Professor |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College and Hospital, Vidyasagar Road, Midnapore Town, Paschim Medinipur, West Bengal, Pin - 721101
Medinipur
WEST BENGAL
721101
India |
| Phone |
9332132242 |
| Fax |
|
| Email |
bjoybnrjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar Mandi |
| Designation |
Assistant Professor |
| Affiliation |
Midnapore Medical College and Hospital |
| Address |
Department of Anaesthesiology, Midnapore Medical College and Hospital, Vidyasagar Road, Midnapore Town, Paschim Medinipur, West Bengal, Pin - 721101
Medinipur
WEST BENGAL
721101
India |
| Phone |
8697633923 |
| Fax |
|
| Email |
mandiarunkr87@gmail.com |
|
|
Source of Monetary or Material Support
|
| office of the principal,midnapore medical college and hospital and hospital vidyasagar road paschim medinipur 721101 |
|
|
Primary Sponsor
|
| Name |
Office of the Principal Midnapore Medical College and Hospital |
| Address |
Office of the Principal, Midnapore Medical College and Hospital, Vidyasagar Road, Midnapore Town, Paschim Medinipur, West Bengal, Pin - 721101 |
| 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 Kuldip batabyal |
Midnapore Medical College and Hospital |
Surgery operation theatre, Post anaesthesia care unit and surgery ward, Midnapore Medical College and Hospital, Vidyasagar Road, Midnapore Town, Paschim Medinipur, West Bengal, Pin - 721101
Medinipur
WEST BENGAL |
7908000122
kuldipbatabyal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Midnapore Medical College and Hospital |
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 |
| Comparator Agent |
Receive IV Dexamethasone 8mg IV Just Before Induction Of General Anaesthesia Plus 30ml/Kg Body Weight Ringer Lactate Solution Intraoperatively |
50 Patients Posted For Cholecystectomy Will Receive IV Dexamethasone 8mg IV Just Before Induction Of General Anaesthesia Plus 30ml/Kg Body Weight Ringer Lactate Solution Intraoperatively, Induced With Fentanyl And Propofol And Maintained With Sevoflurane And N2O. |
| Intervention |
Receive IV dexamethasone 8mg IV just before induction of general anaesthesia, will receive 15ml/kg body weight of ringer lactate preoperatively |
50 Patients Posted For Cholecystectomy Will Receive IV Dexamethasone 8mg IV Just Before Induction Of General Anaesthesia, Induced With Fentanyl And Propofol And Maintained With Sevoflurane And N2O. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Posted for elective laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Severe Cardiopulmonary disease
Hepatic and Renal Failure
Neurologic disorder
Endocrine disorder
Not given Consent
Psychiatric Problem
Allergy to dexamethasone |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and know about the efficacy of Dexamethasone plus intraoperative fluid load of 30ml/kg in preventing post operative nausea and vomiting when compared with Dexamethasone alone |
2hour, 4 hour, 6 hour, 12 hour, 18 hour, 24 hour after completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the requirement of rescue antiemetic between two groups
2. To compare the requirement of rescue analgesic during the first 24hr.
3. To compare the hemodynamic changes between two groups in intra operative & postoperative period.
4. To study the side effects if any attributable to drugs & infusion of liberal fluid.
|
2HR,4HR,6HR,12HR,18HR,24HR |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/01/2024 |
| 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="1"
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
|
PROPOSED TOPIC OF
RESEARCH: Dexamethasone Versus
Dexamethasone Plus Intraoperative Intravenous Ringer Lactate (30mi/Kg) Infusion
to Prevent Postoperative Nausea Vomiting in Patients Undergoing Laparoscopic
Cholecystectomy: A Prospective, Randomised, Double Blinded Study
OBJECTIVE OF
PROPOSED RESEARCH:
1. To
compare the efficacy of dexamethasone alone & dexamethasone plus
intraoperative intravenous ringer
lactate (30 ml/kg) infusion in preventing PONV in patients undergoing laparoscopic
cholecystectomy operation.
2. Comparison
of analgesic requirement, rescue antiemetic requirement between the two groups.
Background
of present study:
PONV is a common complication following laparoscopic surgeries. Dexamethasone
has a prophylactic effect on PONV. This study is research of a model where
dexamethasone is combined with intraoperative fluid load of 30ml/kg in
prevention of PONV in comparison with dexamethasone alone.
Methodology: This study is
institution based, prospective, randomised study on patients undergoing
laparoscopic surgery under general anaesthesia in surgery OT of MMCH. In this
study a total number of 100 patients who will undergo laparoscopic cholecystectomy
will be taken & randomized equally in two groups. Group A set of patients will
get dexamethasone (8mg) alone; whereas the group B patients will receive
dexamethasone plus IV fluid load of 30ml/kg body weight. Anaesthetic &
Surgical management will be standardized. The occurrence and severity of PONV
& analgesic requirement in the postoperative patients will be assessed for
24 hours after surgery.
Expected outcome: As we are using
equipotent doses of dexamethasone (8mg) in both sets of patients but using
liberal fluid (30ml/kg) in excess for the group B patients; we are expecting
that incidence & severity of PONV will significantly decrease in the group
B.
|