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

NCT ID: NCT02537249

Last Updated: 2015-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

Saline 0.9%

Group Type: SHAM_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

Other Intervention Names

Precedex; Saline 0.9%

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2015-0556

Identifier Type: -

Identifier Source: org_study_id