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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04745273
Other study ID # SevgiB
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2, 2020
Est. completion date June 25, 2021

Study information

Verified date November 2022
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 25, 2021
Est. primary completion date June 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Acibadem Kozyatagi Hastanesi Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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