Postoperative Analgesia of Intraoperative Dexmedetomidine Infusion during Laparoscopic Surgery : a randomized controlled study.

JRCT ID: jRCTs051200056

Registered date:08/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients undergoing laparoscopic surgery under general anesthesia, without epidural anesthesia.
• Date of first enrollment: 11/11/2020
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Continuous infusion of dexmedetomidine at 0.5 mcg/kg/h during surgery

Outcome(s)

• Primary Outcome: Maximum pain score from the time returning to the ward to the 1st day after surgery

Secondary Outcome

- Evaluation of analgesia on the postoperative day 1
- The amount of additional nighttime analgesics
- Quality of Recovery Score after returning to Hospital Ward
- Comparison of heart rate and blood pressure

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

(1) Patients undergoing elective laparoscopic surgery under general anesthesia, without epidural anesthesia
(2) Patients undergoing surgery in which the expected anesthesia time exceeds 3 hours
(3) Men and women over 20 years old and less than 80 years old
(4) Patients who have the ability to listen to written explanations and consent on their own

Exclude criteria

(1) A history of hypersensitivity to any of the components of dexmedetomidine
(2) Decreased cardiac function (e.g., history of ischemic heart disease, heart failure, and severe valve
disease)
(3) Heart rate: less than 50 beats per minute or more than 90 beats per minute on the preoperative ECG
(4) Systolic blood pressure: less than 90 mmHg or greater than 160 mmHg in the preoperative anesthesia
outpatient clinic
(5) Abnormalities on preoperative EDC (QT prolongation, left and right bundle branch block, 2nd and 3rd
degree atrioventricular block, multiple ventricular extrasystoles)
(6) Severe anemia (preoperative hemoglobin level less than 8g/dl)
(7) Hepatic dysfunction (Child-Pugh classification B or higher, or liver enzymes (AST, ALT, gamma-GTP) are
more than 2 times as the upper limit of normal)
(8) Impaired renal function (dialysis patients or estimated GFR is less than 30)
(9) Decreased respiratory function (preoperative SpO2 less than 94 percent on room air or receiving oxygen
therapy), patients who are expected to be difficult to extubate in the operating room
(10) BMI of 35 (kg/m2) or more
(11) Known drug abuse, heavy alcohol consumption, or drug dependence (e.g., sleeping pills)
(12) A painkiller user prior to surgery due to chronic or acute pain (a topical medicine and a medicine to
be taken as needed are acceptable)
(13) A patient who is judged by the principal investigator (or subspecialist) to be inappropriate to participate
in this study

Related Information

• Primary Sponsor: Yamashita Hiroshi
• Secondary ID(s): UMIN000039944