1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. 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.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response (Others) -  ANY


6. For how long will this data be available start date provided 01-08-2024 and end date provided 01-01-2030?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

SUMMARY:

Proposed topic of research : COMPARISON OF EFFECT OF INTRAPERITONEAL VERSUS INTRAVENOUS DEXAMETHASONE ON POSTOPERATIVE NAUSEA, AND VOMITING AFTER LAPAROSCOPIC CHOLECYSTECTOMY: A PROSPECTIVE, RANDOMISED, DOUBLE BLINDED STUDY.

Objective of research:

Comparison of efficacy of Intraperitoneal Dexamethasone with Intravenous Dexamethasone in preventing Post operative nausea & vomiting.

Background of research:

Despite all of the benefits provided by laparoscopic cholecystectomy, the Post operative nausea & vomiting is the common & distressful side effect of laparoscopic surgeries. It can negatively affect patient dissatisfaction; readmission & prolonged hospital stay and  increased medical costs. Multimodal approaches are being considered for prophylaxis of post operative nausea & vomiting. Intravenous Dexamethasone reduces post operative nausea & vomiting after laparoscopic surgeries. In this study we aim to find out if Intraperitoneal Dexamethasone would work better than Intravenous  Dexamethasone to reduce post operative nausea & vomiting following laparoscopic cholecystectomy in adult female patients.        

Methodology:

It is a hospital based prospective, randomized, double blinded, study on adult female patients undergoing laparoscopic cholecystectomy under general anaesthesia in surgery OT of Midnapore Medical College and Hospital. A total of  100 patients will be selected randomly in two groups where one group will Receive prophylactic dexamethasone 8mg IV, the second group will receive Dexamethasone 8mg IP.  Anaesthetic and surgical management will be standardized in each group. The required parameters will be monitored in the intraoperative and postoperative period up to 24 hours postoperative period  .                                                                                                                                                                                                                                                                   

Expected outcome of proposed study:

We are expecting that incidence & severity of PONV will significantly decrease in the group intraperitoneal Dexamethasone group following laparoscopic cholecystectomy.