Interaction Between Tramadol and Ondansetron

Overview

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.

Full Title of Study: “The Effect of Ondansetron on the Efficacy of Tramadol”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • Primary Purpose: Health Services Research
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: June 25, 2021

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.

Interventions

• Drug: Ondansetron 4 MG (Kemoset 4mg)
  • Ondansetron 4mg (iv) will administer to participants
• Other: Salin solution
  • Salin solution 2ml (iv) will administer to participants

Arms, Groups and Cohorts

• Active Comparator: Ondansetron
  • Participants will receive Kemoset 4 mg iv intraoperatively
• Placebo Comparator: Salin solution
  • Participants will receive Salin solution 2ml (iv) intraoperatively

Clinical Trial Outcome Measures

Primary Measures

• Interaction
  • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Acibadem University
• Provider of Information About this Clinical Study
  • Principal Investigator: Sevgi Bilgen, Associate professor – Acibadem University
• Overall Official(s)
  • Sevgi Bilgen, Assoc. Prof., Study Chair, Anethesiologist