COMPARISON OF INTRAVENOUS PALONOSETRON, DEXAMETHASONE AND THEIR COMBINATION AS ANTIEMETIC THERAPY IN LAPAROSCOPIC SURGERIES

Active, not recruiting

• Conditions: Adult ASA Grade I or II patients of either sex, aged 18 to 60 years, who underwent elective laparoscopic surgeries undergeneral anaesthesia.

• Registration Number: CTRI/2016/07/007108
• Lead Sponsor: Dr Neha Sadhoo

Brief Summary

This study endeavoured to compare the efficacy of the combination of Palonosetron and Dexamethasone with that of either drug alone in prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgeries. In conclusion, the results of the present study indicate that: 1. The incidence of postoperative nausea and vomiting after laparoscopic surgeries is very high. 2. Both prophylactic intravenous palonosetron (0.075 mg) and dexamethasone (8 mg) are safe and effective in reducing the incidence of postoperative nausea and vomiting for 24 hours after surgery. 3. The combination therapy of palonosetron plus dexamethasone did not significantly reduce the incidence of postoperative nausea and vomiting (PONV) when compared with either drug alone. 101 4. The combination therapy with intravenous palonosetron and dexamethasone should only be reserved for patients who are at extremely high risk of developing PONV after laparoscopic surgeries. 5. There is a current need for a definitive study to further examine the role of combination therapy of palonosetron and dexamethasone in preventing postoperative nausea and vomiting after laparoscopic surgeries as the real benefit to patients will only be realized if these combinations make PONV a rare occurrence.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-28
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Adult ASA Grade I or II patients, who underwent elective laparoscopic surgeries under general anaesthesia.

Exclusion Criteria

• Pregnant or lactating females 2.
• Patients older than 60 years or younger than 18 years of age 3.
• Patients with a history of central nervous system or neuromuscular disease 4.
• Patients with ASA physical status grade > II 5.
• Morbidly obese patients 6.
• Patients with hepatic, renal or cardio-respiratory disease 7.
• Patients with gastro-esophageal reflux 8.
• Patients with history of drug or alcohol abuse 9.
• Patients with known hypersensitivity to either Palonosetron or Dexamethasone 10.
• Patients with previous history of PONV or motion sickness 11.
• Patients receiving chemotherapy or radiotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vomiting ).	0, l, 2, 4, 8 and | 24 hours
2. Number of patients needing rescue antiemetic treatment.	0, l, 2, 4, 8 and | 24 hours
3. Pain intensity scores- obtained with VAS test.	0, l, 2, 4, 8 and | 24 hours
1. Incidence of PONV- using a 3- point scale ( 0-none, 1-nausea, 2-	0, l, 2, 4, 8 and | 24 hours

Secondary Outcome Measures

Name	Time	Method
1. Heart rate	2. Blood pressure

Trial Locations

Locations (1)

Batra Hospital and Medical Research Centre; 🇮🇳 South, DELHI, India

Batra Hospital and Medical Research Centre

🇮🇳South, DELHI, India

Dr Neha Sadhoo

Principal investigator

9560509710

nehasadhoo@gmail.com