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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron | Active Comparator | Participants will receive Kemoset 4 mg iv intraoperatively |
|
| Salin solution | Placebo Comparator | Participants will receive Salin solution 2ml (iv) intraoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron 4 MG (Kemoset 4mg) | Drug | Ondansetron 4mg (iv) will administer to participants |
|
| 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 |
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Inclusion Criteria:
60 patients over the age of 18, ASA I-II, undergoing laparoscopic cholecystectomy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sevgi Bilgen, Assoc. Prof. | Anethesiologist | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acibadem Kozyatagi Hastanesi | Istanbul | (_34742__) ______ | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35685538 | Derived | 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. |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Salin solution | Other | Salin solution 2ml (iv) will administer to participants |
|
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |