Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block

Last updated: June 14, 2023
Sponsor: Yuzuncu Yıl University
Overall Status: Completed

Phase

N/A

Condition

Anesthesia (Local)

Treatment

Dexmedetomidin + bupivacaine

Tramadol + Bupivacaine

Clinical Study ID

NCT05905757
2023/2
  • Ages 20-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Dexmedetomidin + bupivacaine
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
April 03, 2023

Study 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.

Connect with a study center

  • Van Yuzuncu Yil University

    Van, 65100
    Turkey

    Site Not Available

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