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

to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic Drugs Clinical Trial

Official title:

Comparative Study Between Ondansetron, Isopropyl Alcohol Inhalation and Super Hydration in Treatment of Postoperative Emesis After Laparoscopic Appendectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403191
• Other study ID #: ICU-10-20
• Status: Completed
• Start date: March 10, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: March 2020
• Source: King Abdul Aziz Specialist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 10, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

postoperative nausea and vomiting

Exclusion Criteria:

systemic disease as diabetes or hypertension local gastric diseases

Related Conditions & MeSH terms

• to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic Drugs
• Vomiting

Intervention

Drug:
• Ondansetron
ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group
• isopropyl alcohol 70% inhalation
inhalation every 15 min for 4 times then repeated after 6 hours

Procedure:
• laparoscopic appendectomy
all patients received post operatively after laparoscopic appenectomy

Locations

Country	Name	City	State
Saudi Arabia	King abd el Aziz specialist hospital	Taif

Sponsors (1)

Lead Sponsor	Collaborator
King Abdul Aziz Specialist Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numbers of vomiting attacks	numbers of vomiting attacks recorded every 15 minutes for one day	for one day