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

NCT04403191 | Completed DMC FDA Drug

• 1 other identifier: ICU-10-20
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• numbers of vomiting attacks

  numbers of vomiting attacks recorded every 15 minutes for one day

  for one day

Study Arms (3)

Group A

received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours

Drug: Ondansetron; Procedure: laparoscopic appendectomy

Group B

received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours

Drug: isopropyl alcohol 70% inhalation; Procedure: laparoscopic appendectomy

Group C

received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours.

Procedure: laparoscopic appendectomy

Interventions

Ondansetron DRUG

ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group

Group A

isopropyl alcohol 70% inhalation DRUG

inhalation every 15 min for 4 times then repeated after 6 hours

Group B

laparoscopic appendectomy PROCEDURE

all patients received post operatively after laparoscopic appenectomy

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

240 patients admitted to surgical I.C.U of King Abdul-Aziz specialist hospital for post-operative care after laparoscopic appendectomy surgery between March 2019 till February 2020. A Koivuranta Score to Predict Postoperative Nausea and Vomiting done preoperatively for all the patients and only those who had score of more than 3 on Koivuranta vomiting score (had more than 60% chance to develop PONV) enrolled in our study. And randomly allocated in one of three groups group A, B or C.

You may qualify if:

• postoperative nausea and vomiting

You may not qualify if:

• systemic disease as diabetes or hypertension local gastric diseases

Sponsors & Collaborators

• King Abdul Aziz Specialist Hospital: lead

Study Sites (1)

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

Location

MeSH Terms

Interventions

Ondansetron; 2-Propanol; Inhalation

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Propanols; Alcohols; Organic Chemicals; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 27, 2020
• Study Start: March 10, 2019
• Primary Completion: February 4, 2020
• Study Completion: February 10, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)