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OpenTrials
Completed

NCT Number: NCT04745273

Interaction Between Tramadol and Ondansetron

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.

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Key information

Conditions

Cholecystectomy, Laparoscopic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Acibadem Kozyatagi Hastanesi

Istanbul, (_34742__) ______, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ondansetron 4 MG (Kemoset 4mg)

Drug

Ondansetron 4mg (iv) will administer to participants

Other names: Kemoset

Salin solution

Other

Salin solution 2ml (iv) will administer to participants

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

The Effect of Ondansetron on the Efficacy of Tramadol

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2021
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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