Cholecystectomy, Laparoscopic
Conditions
Keywords
tramadol, ondansetron
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.
Interventions
DRUGOndansetron 4 MG (Kemoset 4mg)
Ondansetron 4mg (iv) will administer to participants
OTHERSalin solution
Salin solution 2ml (iv) will administer to participants
Sponsors
Acibadem University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interaction | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed