Interaction Between Tramadol and Ondansetron

November 6, 2022 updated by: Sevgi Bilgen, Acibadem University

The Effect of Ondansetron on the Efficacy of Tramadol

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, (_34742__) ______
        • Acibadem Kozyatagi Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ondansetron
Participants will receive Kemoset 4 mg iv intraoperatively
Drug: Ondansetron 4 MG (Kemoset 4mg)
Ondansetron 4mg (iv) will administer to participants
Other Names:
  • Kemoset
PLACEBO_COMPARATOR: Salin solution
Participants will receive Salin solution 2ml (iv) intraoperatively
Other: Salin solution
Salin solution 2ml (iv) will administer to participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Study Chair: Sevgi Bilgen, Assoc. Prof., Anethesiologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 2, 2020

Primary Completion (ACTUAL)

June 25, 2021

Study Completion (ACTUAL)

June 25, 2021

Study Registration Dates

First Submitted

January 31, 2021

First Submitted That Met QC Criteria

February 7, 2021

First Posted (ACTUAL)

February 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 6, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SevgiB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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