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

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Saudi Arabia
  • Taif, Saudi Arabia, 21944
    • King abd el Aziz specialist hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

postoperative nausea and vomiting

Exclusion Criteria:

systemic disease as diabetes or hypertension local gastric diseases

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours	Drug: Ondansetron; ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group; Procedure: laparoscopic appendectomy; all patients received post operatively after laparoscopic appenectomy
Group B; received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours	Procedure: laparoscopic appendectomy; all patients received post operatively after laparoscopic appenectomy; Drug: isopropyl alcohol 70% inhalation; inhalation every 15 min for 4 times then repeated after 6 hours
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; all patients received post operatively after laparoscopic appenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numbers of vomiting attacks	numbers of vomiting attacks recorded every 15 minutes for one day	for one day

Collaborators and Investigators

• Sponsor: King Abdul Aziz Specialist Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2019
• Primary Completion (Actual): February 4, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: ICU-10-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes