| CTRI Number |
CTRI/2025/08/093800 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate the effectiveness of one antiemetic drug versus
two antiemetic drugs in preventing nausea and vomiting in patients undergoing laparoscopic gall bladder removal surgery without use of opioids. |
|
Scientific Title of Study
|
Comparative evaluation of single agent with dual agent antiemetic regimen for post operative nausea and vomiting prophylaxis in patients undergoing laparoscopic cholecystectomy with opioid free anaesthesia. |
| 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 Eunica Alias |
| Designation |
Post graduate resident, Department of Anaesthesiology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College
Bahadur Shah Zafar Road
near Delhi Gate
Delhi-110002
Central
DELHI
110002
India |
| Phone |
8750612343 |
| Fax |
|
| Email |
eunicaaliasnv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Wadhwa |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.314
BL Taneja block
Maulana Azad Medical College
New Delhi -110002
Central
DELHI
110002
India |
| Phone |
01123239271 |
| Fax |
|
| Email |
drbhartitaneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Wadhwa |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.314
BL Taneja block
Maulana Azad Medical College
New Delhi -110002
Central
DELHI
110002
India |
| Phone |
01123239271 |
| Fax |
|
| Email |
drbhartitaneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College
Bahadur Shah Zafar Marg,near Delhi Gate, Delhi 110002,India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College
Bahadur Shah Zafar Marg
Near Delhi Gate
Delhi 110002 |
| 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 Eunica Alias |
OT1,1st floor, OT block, Lok Nayak Hospital |
Jawaharlal Nehru Marg, Maulana Azad Medical College Campus, Delhi 110002,India
Central
DELHI |
8750612343
eunicaaliasnv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College and associated hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Single antiemetic agent and dual antiemetic agent prophylaxis |
Three groups, first group recieves ondansetron 4mg iv 30 mins before end of surgery , second group recieves dexamethasone 0.1mg per kg at start of surgery,third group recieves both ondansetron 4mg iv and dexamethasone 0.1 mg per kg as antiemetic prophylaxis. |
| Intervention |
Single vs dual antiemetic prophylaxis in patients posted for laparoscopic cholecystectomy under opioid free anaesthesia |
Opioid free general anaesthesia is given in all three groups with dexmedetomidine 0.5mcgper kgpermin loading dose followed by maintainance dose of 0.2-0.7 MCG per kg per hour . Induction is done with propofol infusion via TCI pump Ce 4mcg/ml dose titrated throughout surgery to maintain BIS 40-60 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients
Age 18-65 years |
|
| ExclusionCriteria |
| Details |
BMI more than or equal to 35 kg per metre square
Patient with history of PONV and motion sickness
Patients with cardiac conduction defects and significant cardiac disease
Patient who had received opioids,non steroidal antiinflamatory drugs, steroids, antiemetic agents during previous 24 hours
History of allergy to therapeutic drugs used in the study
History of neurobehavioral disorders
Pregnancy and lactation |
|
|
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 |
| Incidence of post operative nausea and vomiting in first 24 hours after surgery in patients posted for laparoscopic cholecystectomy under opioid free general anaesthesia. |
at 0,0-2 ,2-6,6-12,12-24 interval hours after laparoscopic cholecystectomy under opioid free general anaesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PONV using PONV score |
at 0,0-2 ,2-6,6-12,12-24 interval hours after laparoscopic cholecystectomy under opioid free general anaesthesia.ponv using PONVscore |
| Number of patients having clinically significant PONV using PONV impact scale |
at 0,0-2 ,2-6,6-12,12-24 interval hours after laparoscopic cholecystectomy under opioid free general anaesthesia. |
| Time from end of surgery to requirement of rescue antiemetic |
Nil |
| Total consumption of antiemetic over 24 hrs post operative |
Nil |
| Time taken for resolutin of PONV after administration of rescue antiemetic. |
Nil |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
08/09/2025 |
| 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 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
|
Laparoscopic cholecystectomy is gaining popularity due to less post operative ileus ,pain and shorter hospital stay.Post operative nausea and vomiting is the most common distressing side effect associated with laparoscopic cholecystectomy,and is left untreated it can cause post operative bleeding wound dehiscence,gastric aspiration and electrolyte imbalance.As per recent guidelines multimodal post operative nausea and vomiting prophylaxis is adviced.Many studies have shown that opioid free general anaesthesia itself helps reduce the incidence of PONV with fewer post operative side effects. We hypothesize that in patients recieving opioid free general anaesthesia with propofol and dexmedetomidine the standard dual antiemetic prophylaxis may not be needed.There is limited body of work on this aspect of opioid free Anaesthsia.We aim to evaluate the need for single antiemetic agent or dual antiemetic agents as prophylaxis for post operative nausea and vomiting in patients posted for laparoscopic cholecystectomy under opioid free anaesthesia. |