Interaction Between Tramadol and Ondansetron

Phase 4

Completed

• Conditions: Cholecystectomy, Laparoscopic
• Interventions: Drug: Ondansetron 4 MG (Kemoset 4mg); Other: Salin solution

• Registration Number: NCT04745273
• Lead Sponsor: Acibadem University

Brief Summary

In the postoperative period; pain, nausea, and vomiting are undesirable side effects that reduce the patient's comfort and may lead to various complications. Ondansetron is frequently used as an antiemetic and tramadol hydrochloride is used for postoperative analgesia in laparoscopic cholecystectomy. However, some studies have reported that there is a drug interaction between these two drugs and they reduce each other's effects, thus requiring more analgesics in the postoperative period.

The aim of this study is; To evaluate whether ondansetron reduces the analgesic efficacy of tramadol hydrochloride in laparoscopic cholecystectomies.

Detailed Description

During the operation, 4 mg iv ondansetron (2mL) will be administered to the ondansetron group and 2mL iv 09% saline will be administered to the placebo group. The patients' heart rate, blood pressure, oxygen saturation, sedation score (with Ramsey Seading Score), amount of pain (with NRS), degree of nausea (with NRS), whether there is vomiting, whether analgesic or antiemetic treatment is required, and the amount of tramadol use will be recorded at 1, 2, 4, 8, 12 and 24 hours in the postoperative period.

Study Timeline

• Study Start: 2020-09-02
• Study First Submitted: 2021-01-31
• Study First Submitted QC: 2021-02-07
• Study First Posted: 2021-02-09
• Primary Completion: 2021-06-25
• Study Completion: 2021-06-25
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

60 patients over the age of 18, ASA I-II, undergoing laparoscopic cholecystectomy

Exclusion Criteria

1. Patients under 18 years of age
2. Patients with known allergies to the drugs to be used
3. Pregnant and breastfeeding mothers
4. Patients who received antiemetic or cortisone within 24 hours before surgery
5. Patients with mental illness or epilepsy
6. Patients with alcohol or substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Ondansetron	Ondansetron 4 MG (Kemoset 4mg)	Participants will receive Kemoset 4 mg iv intraoperatively
Salin solution	Salin solution	Participants will receive Salin solution 2ml (iv) intraoperatively

Primary Outcome Measures

Name	Time	Method
Interaction	24 hours	The hypothesis of this study is that if ondanstron is given together with tramadol peroperatively, tramadol consumption is increase postoperatively due to tramadol ondansetron interaction. The primary outcome measure is consumption of tramadol postoperatively for 24 hours.

Trial Locations

Locations (1)

Acibadem Kozyatagi Hastanesi; 🇹🇷 Istanbul, Turkey