Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients
Conditions
- Lung Cancer
Conditions: Keywords
Dexamethasone, Quality of recovery questionnaire, QoR-40, Lung cancer, Video-assisted thoracoscopic
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Intervention
Name: Dexamethasone IV Type: Drug
Name: Saline solution Type: Drug
Overall Status
Not yet recruiting
Summary
The proposed study is a randomized, double-blind, placebo-controlled evaluation if a small dose of IV dexamethasone during induction anesthesia in association to pre and postoperative intercostal nerve block, improves quality of recovery of thoracoscopic lung resection patients.
Detailed Description
This is a study composed by 2 groups of 50 patients undergoing VATS for lung cancer. All subjets will receive intraoperative intercostal nerve block with a maximum dose of 2 mg/kg of bupivacaine with epinephrine 1:200.000 at the beginning and at the end of procedure.

The control group will receive a bolus dose of dexamethasone (0.1 mg/kg) and the placebo group saline solution. The study drug or placebo will be administered at the time of anesthetic induction (approximately 30 minutes before surgical incision). Patients will be evaluated daily with the quality of recovery questionary, visual analogue pain and portable spirometry. And, the patients will have pulmonary lung function assessed by portable spirometry.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- resectable stage I and II lung cancer patients submitted to VATS

- american society of anesthesiology Classification (ASA) I or II

Exclusion Criteria:

- chronic pain;

- chronic analgesic consumption;

- severe renal or liver disease;

- endocrine or mental diseases;

- poorly controlled diabetes;

- allergy to bupivacaine;

- previous thoracotomy;

- systemic use of corticosteroids;

- morbid obesity;

- poor French comprehension precluding completion of the QoR-40 questionnaire;

- patient refusal.
Location
Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ
Québec, Quebec, Canada
Status: Not yet recruiting
Contact: Guilherme Dal Agnol, Fellowship - +14185707295 - guilherme.dal.agnol@criucpq.ulaval.ca
Start Date
October 2014
Completion Date
October 2015
Sponsors
Laval University
Source
Laval University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page