Trials / Completed
CompletedNCT05905757
Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block
Intraoperative and Postoperative Effects of Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Yuzuncu Yil University · Academic / Other
- Sex
- All
- Age
- 20 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
In this study, dexmedetomidine and tramadol were added as adjuvant to bupivacaine in transversus abdominis plane block (TAP), intraoperative hemodynamics, opioid consumption, muscle relaxant use, postoperative analgesic effects and side effects (such as nausea-vomiting) were evaluated.
Detailed description
The study was carried out with 60 ASA I-II class participants aged 20-60 years who underwent laparoscopic cholecystectomy at Van Yuzuncu Yıl University Faculty of Medicine. Preoperative evaluation was made before the operation, routine laboratory analyzes were taken, the participants were informed about the study, and their written consent was obtained. Participants were randomized into two groups. * Group T (Adjuvant Tramadol): 40 mL of 0.250% bupivacaine + 1.5mg/kg and a maximum of 100 mg tramadol adjuvant * Group D (Adjuvant Dexmedetomidine): 40 mL of 0.250% bupivacaine + 0.5 mcg/kg and a maximum of 50 mcg dexmedetomidine adjuvant Standard general anesthesia was applied. After intubation, bilateral subcostal TAP block was performed by the same anesthesiologist, demographic data were recorded. Intraoperative vital signs of the participants (pulse, non-invasive blood pressure and peripheral oxygen saturation measurement), additional opioid and muscle relaxant needs, and complications were recorded. Extubation was performed after standard decurarization with atropine and neostigmine. Postoperative side effects (nausea, vomiting, pruritus, shivering), postoperative additional analgesic need, and 0 hour (Modified aldrete score ≥9 time was accepted as 0 hour), 3rd hour and 6th hour Visual Analogue Scale (VAS) scores were evaluated and recorded.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Dexmedetomidin + bupivacaine | dexmedetomidine was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP) |
| DRUG | Tramadol + Bupivacaine | tramadol was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP) |
Timeline
- Start date
- 2022-03-01
- Primary completion
- 2023-03-01
- Completion
- 2023-04-03
- First posted
- 2023-06-15
- Last updated
- 2023-06-15
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT05905757. Inclusion in this directory is not an endorsement.