Effects of Dexmedetomidine on Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery

Dexmedetomidine is a selective α2 adrenergic agonist that can be considered analgesics, anxiolytic,and anti-stress effect . This randomized, double-blind placebo-controlled trial of intraoperative dexmedetomidine for improvement of quality of recovery and analgesia from surgery. Patients scheduled to undergo video-assisted thoracoscopic surgery (VATS) will be enrolled. Patients will be recruited before the date of their surgery and will complete the Quality of Recovery-40 (QoR-40) questionnaire before their surgery and at 24 and 48 hours post op. They will also complete clinically significant pains score and oxygenation from the postanesthetic recovery unit (PACU).

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Video-Assisted Thoracoscopic Surgery

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The inclusion criteria included patients scheduled video-assisted thoracoscopic surgery for lung cancer
Adults above 20 years of age and providing informed consent.
American Society of Anesthesiologists (ASA) Physical class II, & III patients

Exclusion criteria

severe functional liver or kidney disease
history of chronic pain requiring opioid treatment
arrhythmia or received treatment with antiarrythmic drug .
severe bradycardia (HR < 45 bpm) and AV block
pathologic esophageal lesion (esophageal stricture or varix )
pregnancy
psychiatric/central nervous system disturbance that would preclude completion of the QoR-40 questionnaire
History of alcohol or drug abuse

Treatment and study plan

Dexmedetomidine

Drug

Formula for administrated were randomized by computer-generated randomization. The patients and anesthesiologist, who administered and conducted all this trial, were blinded to the medication allocation. An anesthesiologist, who responsible for preparation of medication was the only person, recognized of the randomization code during trial. After one-lung ventilation, dexmedetomidine group would start the loading of dexmedetomidine (1μg/kg) during 20 minutes.

Other names: Precedex

normal saline

Drug

Saline placebo infusion will be adjusted the same fashion as the active comparator drug.

Other names: Saline 0.9%

Primary outcomes

quality of recovery measured by QoR-40 questionnaire

Time frame: 24 hr after operation
pulmonary function test

Time frame: 24 hr after operation

postoperative lung function assessed by spirometry

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Sep 1, 2015
Registry last updated: Nov 11, 2015

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.

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