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

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537249
• Other study ID #: 4-2015-0556
• Status: Completed
• Phase: N/A
• First received: August 24, 2015
• Last updated: November 9, 2015
• Start date: August 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

1. The inclusion criteria included patients scheduled video-assisted thoracoscopic surgery for lung cancer

2. Adults above 20 years of age and providing informed consent.

3. American Society of Anesthesiologists (ASA) Physical class II, & III patients

Exclusion Criteria:

1. severe functional liver or kidney disease

2. history of chronic pain requiring opioid treatment

3. arrhythmia or received treatment with antiarrythmic drug .

4. severe bradycardia (HR < 45 bpm) and AV block

5. pathologic esophageal lesion (esophageal stricture or varix )

6. pregnancy

7. psychiatric/central nervous system disturbance that would preclude completion of the QoR-40 questionnaire

8. History of alcohol or drug abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Lung Cancer
• Video-assisted Thoracoscopic Surgery

Intervention

Drug:
• Dexmedetomidine
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.
• Normal saline
Saline placebo infusion will be adjusted the same fashion as the active comparator drug.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of recovery measured by QoR-40 questionnaire		24 hr after operation	Yes
Primary	pulmonary function test	postoperative lung function assessed by spirometry	24 hr after operation	Yes