Comparison of effect of intraperitoneal versus intravenous dexamethasone on postoperative nausea, and vomiting after laparoscopic cholecystectomy: A prospective, randomised, double blinded study
Overview
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Principal, Midnapore Medical College & Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence and severity of post operative nausea and vomiting
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •ASA grade I & II.
- •Female patients.
- •Patients undergoing laparoscopic Cholecystectomy.
- •Patients giving valid consents.
Exclusion Criteria
- •Patients with severe cardio-respiratory disease
- •Patients with hepatic & renal disease
- •Patients with neurologic disorder
- •Patients with endocrine disorder
- •Patients who will not give valid consent.
- •Patients with H/O dexamethasone allergy.
- •Patients with pregnancy.
Outcomes
Primary Outcomes
Incidence and severity of post operative nausea and vomiting
Time Frame: 2, 4, 8, 12, and 24 hours after laparoscopy.
Secondary Outcomes
- 1. To compare the requirement of rescue antiemetic between the two groups.(2. To compare the requirement of rescue analgesic between the two groups during the first 24hour)
Investigators
Dr Bijoy Kumar Bandyopadhyay
Midnapore Medical College & Hospital