Skip to main content
OpenTrials
Completed

NCT Number: NCT05905757

Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University

Van, 65100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidin + bupivacaine

Procedure

dexmedetomidine was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)

Tramadol + Bupivacaine

Drug

tramadol was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)

Primary outcomes

  1. intraoperative non invasive blood pressure

    Time frame: 10 minutes

    non invasive blood pressure(systolic, diastolic and mean blood pressure)

  2. intraoperative opioid consumption

    Time frame: 40 minutes

    The necessary opioid (mcg) addiction was noted

  3. intraoperative muscle relaxant use

    Time frame: 40 minutes

    The necessary muscle relaxant (mg) addiction was noted

  4. intraoperative heart rate

    Time frame: 5 minutes

    Heart rate was noted

Secondary outcomes

  1. postoperative analgesic effects

    Time frame: 0., 3., 6. hour measurements were evaluated

    Visual analogue scale (VAS) scores were noted.pointed between 0-10. 0:No pain, 5-6-7:medium pain, 9-10:unbearable pain

  2. Number of participants with postoperative side effects

    Time frame: 0., 3., 6. hour measurements were evaluated

    nausea, vomiting, chills. Patients with these effects were noted. Evaluated by the number of people

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Intraoperative and Postoperative Effects of Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.