Interaction Between Tramadol and Ondansetron
The Effect of Ondansetron on the Efficacy of Tramadol
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2020
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2020
CompletedFirst Submitted
Initial submission to the registry
January 31, 2021
CompletedFirst Posted
Study publicly available on registry
February 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2021
CompletedNovember 8, 2022
November 1, 2022
10 months
January 31, 2021
November 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Ondansetron
ACTIVE COMPARATORParticipants will receive Kemoset 4 mg iv intraoperatively
Salin solution
PLACEBO COMPARATORParticipants will receive Salin solution 2ml (iv) intraoperatively
Interventions
Ondansetron 4mg (iv) will administer to participants
Eligibility Criteria
You may qualify if:
- patients over the age of 18, ASA I-II, undergoing laparoscopic cholecystectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Acibadem Kozyatagi Hastanesi
Istanbul, (_34742__) ______, Turkey (Türkiye)
Related Publications (1)
Bilgen S, Erdogan Ari D, Ozveri E. The Effect of Ondansetron on the Analgesic Efficacy of Tramadol in Patients Undergoing Laparoscopic Cholecystectomy. Int J Clin Pract. 2022 Mar 8;2022:7387600. doi: 10.1155/2022/7387600. eCollection 2022.
PMID: 35685538DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sevgi Bilgen, Assoc. Prof.
Anethesiologist
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
January 31, 2021
First Posted
February 9, 2021
Study Start
September 2, 2020
Primary Completion
June 25, 2021
Study Completion
June 25, 2021
Last Updated
November 8, 2022
Record last verified: 2022-11