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

Phase 2

• Conditions: Patients undergoing laparoscopic surgery under general anesthesia, without epidural anesthesia.

• Registration Number: JPRN-jRCTs051200056
• Lead Sponsor: Yamashita Hiroshi

Brief Summary

Intraoperative dexmedetomidine at the maintenance doses was administered without significant hemodynamic changes and significantly reduced resting pain after returning postoperative care unit. Intraoperative administration of dexmedetomidine not only provided immediate postoperative analgesia, but also sustained mild analgesia for a relatively long time as prophylactic analgesia, improving pain scores and recovery quality scores on the next morning after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-08
• Study Completion: 2021-09-17
• Results First Posted: 2022-03-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified