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

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ClinicalTrials.gov Identifier: NCT02275702
Recruitment Status : Unknown
Verified March 2016 by Laval University.
Recruitment status was:  Recruiting
First Posted : October 27, 2014
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Laval University

Brief 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.

Condition or disease Intervention/treatment Phase
- Lung Cancer Drug: Dexamethasone IV Drug: Saline solution Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group 1
saline solution IV, bolus
Drug: Saline solution
Active Comparator: Group 2
0,1mg/kg systemic dose of dexamethasone, bolus
Drug: Dexamethasone IV
It will be administered at the induction of the anesthesia
Other Name: Decadron




Primary Outcome Measures :
  1. The primary outcome of this study will be postoperative quality of recovery measured by postoperative quality of recovery score 40 (QoR-40) global score. [ Time Frame: During the hospital stay and 1 year later ]

Secondary Outcome Measures :
  1. Time of analgesia between the final intercostal nerve block and the first patient-controlled analgesia (PCA) request; [ Time Frame: During the hospital stay and 1 year later ]

Other Outcome Measures:
  1. Correlation between pain with visual analog scale and lung function through spirometry test with forced expiratory volume at one second (FEV1) and diffusion capacity (DLCO) [ Time Frame: During the hospital stay and 1 year later ]
  2. Total opioid dose consumption in each group [ Time Frame: During the hospital stay and 1 year later ]
  3. Side-effect of dexamethasone in the stress response to surgery [ Time Frame: During the hospital stay and 1 year later ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275702


Contacts
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Contact: Guilherme Dal Agnol, Fellowship +14185707295 guilherme.dal.agnol@criucpq.ulaval.ca

Locations
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Canada, Quebec
Institut Universitaire de Cardiologie et de Pneumologie de Québec, IUCPQ Not yet recruiting
Québec, Quebec, Canada, G1v 4G5
Contact: Guilherme Dal Agnol, Fellowship    +14185707295    guilherme.dal.agnol@criucpq.ulaval.ca   
Principal Investigator: Paula A Ugalde, Medicin         
Sub-Investigator: Jean Bussières, Medicin         
Sub-Investigator: Yves Lacasse, Medicin         
Sub-Investigator: Guilherme Dal Agnol, Medicin         
Sub-Investigator: Nathalie Gagné, Nurse         
IUCPQ Recruiting
Québec, Quebec, Canada, G1V3H8
Contact: Guilherme Dal Agnol, fellow    4185707295    guilherme.dal.agnol@criucpq.ulaval.ca   
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Paula A. Ugalde, Medicin Institut Universitaire de Cardilogie et Pneumologie de Québec, IUCPQ

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Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT02275702     History of Changes
Other Study ID Numbers: APV-100
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Keywords provided by Laval University:
Dexamethasone
Quality of recovery questionnaire
QoR-40
Lung cancer
Video-assisted thoracoscopic
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action