Usage of Multiple Drugs in Treatment of Postoperative Vomiting After Laparoscopic Appendectomy

Completed

• Conditions: to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic Drugs
• Interventions: Drug: isopropyl alcohol 70% inhalation; Drug: Ondansetron; Procedure: laparoscopic appendectomy

• Registration Number: NCT04403191
• Lead Sponsor: King Abdul Aziz Specialist Hospital

Brief Summary

To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.

Detailed Description

This prospective double-blind study done on 240 patients admitted to surgical I.C.U after laparoscopic appendectomy. Those who had preoperative Koivuranta vomiting score of more than 3 enrolled in our study. Every group contains 80 patients. Patients of group A received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group B received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours. The last group C received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours. The duration of the study was 24 hours post-operatively. As PONV is self-limited within 24 hours.

Study Timeline

• Study Start: 2019-03-10
• Primary Completion: 2020-02-04
• Study Completion: 2020-02-10
• Status Verified: 2020-03
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-27
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

postoperative nausea and vomiting

Exclusion Criteria

systemic disease as diabetes or hypertension local gastric diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	laparoscopic appendectomy	received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours
Group B	isopropyl alcohol 70% inhalation	received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours
Group B	laparoscopic appendectomy	received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours
Group C	laparoscopic appendectomy	received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours.
Group A	Ondansetron	received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours

Primary Outcome Measures

Name	Time	Method
numbers of vomiting attacks	for one day	numbers of vomiting attacks recorded every 15 minutes for one day

Trial Locations

Locations (1)

King abd el Aziz specialist hospital; 🇸🇦 Taif, Saudi Arabia