| CTRI Number |
CTRI/2025/08/093586 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of postoperative nausea and vomiting in patients undergoing laparoscopic removal of gall bladder using narcotic pain killer versus non narcotic pain killer. |
|
Scientific Title of Study
|
Comparative randomised controlled study of PONV(postoperative nausea and vomiting) in laparoscopic cholecystectomy, opioid vs ketamine lignocaine based 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 Haneefa Khan |
| Designation |
Resident |
| Affiliation |
Peerless Hospital & B K Roy Research Centre |
| Address |
Peerless Hospital & B K Roy
Research Centre, 360, Panchasayar,Kolkata.
Kolkata
WEST BENGAL
700094
India |
| Phone |
7981771458 |
| Fax |
|
| Email |
haneefa1khan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avijit Banerjee |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Peerless Hospital & B K Roy Research Centre |
| Address |
Peerless Hospital & B K Roy
Research Centre, 360, Panchasayar, Kolkata.
Kolkata
WEST BENGAL
700094
India |
| Phone |
6289508707 |
| Fax |
|
| Email |
draviban@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avijit Banerjee |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Peerless Hospital & B K Roy Research Centre |
| Address |
Peerless Hospital & B K Roy
Research Centre, 360, Panchasayar ,Kolkata.
Kolkata
WEST BENGAL
700094
India |
| Phone |
6289508707 |
| Fax |
|
| Email |
draviban@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peerless Hospital & B K Roy
Research Centre, 360, Panchasayar, Kolkata, 700094.
|
|
|
Primary Sponsor
|
| Name |
Dr Haneefa Khan |
| Address |
Peerless Hospital & B K Roy
Research Centre, 360, Panchasayar,Kolkata.
|
| 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 Haneefa Khan |
Peerless Hospital & B K Roy Research Centre |
Department of anaesthesiology, Main OT Complex, General Surgery, OT Room number 4, 3rd floor, Peerless Hospital & B K Roy
Research Centre, 360, Panchasayar, Kolkata, 700094.
Kolkata
WEST BENGAL |
7981771458
haneefa1khan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee Peerless Hospitex Hospital And Research Center Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine and Ketamine |
lignocaine (loading dose with 2 mg/kg followed by 1.5 mg/kg/hr continuous infusion) and a single dose of ketamine 0.4 mg/kg given 5 minutes before estimated extubation time .
|
| Comparator Agent |
Morphine |
morphine 0.2 mg/kg.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) The patients who have given informed consent.
2) The Patients of ASA-American Society of Anaesthesiologists Grade I, II.
3) The Patients aged 18 -50yrs.
4) The patients who are electively scheduled for laproscopic cholecystectomy.
|
|
| ExclusionCriteria |
| Details |
1) The patients who refused to participate in the study.
2) The patients with ASA Grade 3 and above.
3) Patients aged below 18 and above 50 years.
4) Vestibular disorders, pregnancy and patients with history of chemotherapy.
5) The patients with known hypersensitivity to the local anaesthetics & Opioids.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduced incidence of PONV(post operative nausea & vomiting) in laproscopic cholecystectomy patients without compromising on intraoperative haemodynamic stability of patient.
|
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevention Of Opioid Related Adverse Effects
|
24 hours |
Early Recovery After Surgery
|
24 hours |
Patients Comfort During Perioperative Period
|
24 hours |
Patients Satisfaction During Perioperative Period.
|
24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Self e-mail (haneefa1khan@gmail.com)
- For how long will this data be available start date provided 30-05-2025 and end date provided 15-12-2031?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
- Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24 hours after surgery.
- PONV is one of the most common causes of patient dissatisfaction and unanticipated hospital admission after anaesthesia, with reported incidences of 40% in patients who undergo general anaesthesia and can be up to 80% in high-risk patients.
- The highest risk patients for PONV appear to be young to middle-aged, non-smoking females with a history of PONV or motion sickness (all are independent risk factors).
- It could result in many adverse events such as discomfort, dehiscence of sutures, increased bleeding, esophageal rupture (Boerhaave’s Syndrome), incisional hernia, raised ICP, dehydration if prolonged, metabolic alkalosis with loss of hydrogen, chloride, potassium, sodium and water, gastric content aspiration, pneumonia and esophageal rupture and result in delayed discharge from the hospital.Increased medical costs, and hospital readmission are all common in cases of PONV.
- As the need for ambulatory surgery increases, the prevention of PONV continues to become more important to the system based approach of anesthesiology
- Our aim is to reduce the incidence of PONV in patients undergoing laproscopic cholecystectomy using opioid versus using lignocaine and ketamine during anaesthesia.
- This is a single institutional Prospective randomised control trial involving 100 patients who underwent laparoscopic cholecystectomy for a period of 15 months from September 2025 to December 2026 in Peerless Hospital And B K Roy Research Centre, Kolkata.
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