Interaction Between Tramadol and Ondansetron

Cholecystectomy, Laparoscopic Clinical Trial

Official title:

The Effect of Ondansetron on the Efficacy of Tramadol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745273
• Other study ID #: SevgiB
• Status: Completed
• Phase: Phase 4
• Start date: September 2, 2020
• Est. completion date: June 25, 2021

Study information

• Verified date: November 2022
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystectomy, Laparoscopic

Intervention

Drug:
• Ondansetron 4 MG (Kemoset 4mg)
Ondansetron 4mg (iv) will administer to participants

Other:
• Salin solution
Salin solution 2ml (iv) will administer to participants

Locations

Country	Name	City	State
Turkey	Acibadem Kozyatagi Hastanesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interaction	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.	24 hours