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

NCT02537249 | Completed

• 1 other identifier: 4-2015-0556
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lung Cancer; Video-assisted Thoracoscopic Surgery

Keywords

dexmedetomidine; quality of recovery

Outcome Measures

Primary Outcomes (2)

• quality of recovery measured by QoR-40 questionnaire

  24 hr after operation

• pulmonary function test

  postoperative lung function assessed by spirometry

  24 hr after operation

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Saline 0.9%

SHAM COMPARATOR

Drug: Normal saline

Interventions

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.

Also known as: Precedex

Dexmedetomidine

Normal saline DRUG

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

Also known as: Saline 0.9%

Saline 0.9%

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults above 20 years of age and providing informed consent.
• American Society of Anesthesiologists (ASA) Physical class II, \& III patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 1, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 11, 2015

Record last verified: 2015-11

Locations

KR (1)