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 Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Maulana Azad Medical College
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Incidence of post operative nausea and vomiting in first 24 hours after surgery in patients posted for laparoscopic cholecystectomy under opioid free general anaesthesia.
Study Overview
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.
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
- All
Inclusion Criteria
- •ASA 1 and 2 patients Age 18-65 years.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Incidence of post operative nausea and vomiting in first 24 hours after surgery in patients posted for laparoscopic cholecystectomy under opioid free general anaesthesia.
Time Frame: at 0,0-2 ,2-6,6-12,12-24 interval hours after laparoscopic cholecystectomy under opioid free general anaesthesia.
Secondary Outcomes
- 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)
Investigators
Dr Eunica Alias
Maulana Azad Medical College