NCT04745273

Interaction Between Tramadol and Ondansetron

The Effect of Ondansetron on the Efficacy of Tramadol

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Acibadem University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cholecystectomy, Laparoscopic

Interventions

Type	Name	Description
DRUG	Ondansetron 4 MG (Kemoset 4mg)	Ondansetron 4mg (iv) will administer to participants
OTHER	Salin solution	Salin solution 2ml (iv) will administer to participants

Timeline

• Start date: 2020-09-02
• Primary completion: 2021-06-25
• Completion: 2021-06-25
• First posted: 2021-02-09
• Last updated: 2022-11-08

Locations

1 site across 1 country: Turkey (Türkiye)