Clinical trial NCT05905757: Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block
Official title: Intraoperative and Postoperative Effects of Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transversus Abdominis Plane Block
Keywords: Transversus abdominis plane block
adjuvant
Dexmedetomidine
Tramadol
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled trial
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 20-60 years old
* Those who will undergo elective laparoscopic cholecystectomy surgery
* Those in ASA I-II physical status
* Those who gave consent to participate in the study

Exclusion Criteria:

* Those outside the age range of 20-60
* Those outside of ASA I-II physical status
* Serious heart, lung, liver disease
* Kidney failure
* Bleeding diathesis
* Those who develop complications during the procedure
* Those with fever, active infection
* Those who are allergic to the drugs to be used
* Those who refused to participate in the study
* Those with hypothermic and acid-base disorders
* Electrolyte disturbances such as hypokalemia, hypocalcemia
* Those taking antibiotics, anticonvulsants, antiarrhythmics, cholinesterase inhibitors
* Pregnant
* Those with bleeding
* BMI 30 and above

Primary outcomes:
measure: intraoperative non invasive blood pressure
timeFrame: 10 minutes
measure: intraoperative opioid consumption
timeFrame: 40 minutes
measure: intraoperative muscle relaxant use
timeFrame: 40 minutes
measure: intraoperative heart rate
timeFrame: 5 minutes
Secondary outcomes:
measure: postoperative analgesic effects
timeFrame: 0., 3., 6. hour measurements were evaluated
measure: Number of participants with postoperative side effects
timeFrame: 0., 3., 6. hour measurements were evaluated
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University
Study officials:
affiliation: Yuzuncu Yıl University
name: School of Medicine Department of Anesthesiology and Reanimation
role: STUDY_CHAIR
References: