Interaction Between Tramadol and Ondansetron

Study Overview
=================
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.

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.

Official Title
-----------------
The Effect of Ondansetron on the Efficacy of Tramadol

Conditions
-----------------
Cholecystectomy, Laparoscopic

Intervention / Treatment
-----------------
* Drug: Ondansetron 4 MG (Kemoset 4mg)
* Other: Salin solution


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ondansetron<br>Participants will receive Kemoset 4 mg iv intraoperatively | Drug: Ondansetron 4 MG (Kemoset 4mg)<br>* Ondansetron 4mg (iv) will administer to participants<br>* Other names: Kemoset;|
| Placebo Comparator: Salin solution<br>Participants will receive Salin solution 2ml (iv) intraoperatively | Other: Salin solution<br>* Salin solution 2ml (iv) will administer to participants<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tramadol, ondansetron