Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1

saline solution IV, bolus

Group Type PLACEBO_COMPARATOR

Saline solution

Intervention Type DRUG

Group 2

0,1mg/kg systemic dose of dexamethasone, bolus

Group Type ACTIVE_COMPARATOR

Dexamethasone IV

Intervention Type DRUG

It will be administered at the induction of the anesthesia

Interventions

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Dexamethasone IV

It will be administered at the induction of the anesthesia

Intervention Type DRUG

Saline solution

Intervention Type DRUG

Other Intervention Names

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Decadron

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No