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Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440960
First Posted: February 27, 2007
Last Update Posted: February 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Pompeia
  Purpose
The objective of the study was to establish which anesthetic procedure used during flexible bronchoscopy has the lowest index of complications.

Condition Intervention Phase
Lung Cancer Drug: propofol Drug: midazolam Drug: alfentanil Drug: lidocaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hospital Pompeia:

Detailed Description:
This prospective randomized study analyzed 80 patients that underwent flexible bronchoscopy. Patients were randomly assigned to four groups of 20 patients each according to the anesthetic combination used: 200 mg topical lidocaine (LID group); 200 mg topical lidocaine and 2 mg/kg propofol (PPF group); 200 mg topical lidocaine and 20 mcg/kg alfentanil (ALF group); or 200 mg topical lidocaine and 0.05 mg/kg midazolam (MID group). Scores were assigned to patients according to the different variables observed during the endoscopic procedure; the lower the score, the lower the complication index.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • The patients included in this study were referred to FBC for the investigation of bronchial carcinoma (diagnostic procedure).
  • Patients included in the study were classified as ASA I, II and II according to the anesthetic risk classification of the American Society of Anesthesiologists (ASA).

Exclusion Criteria:

  • ASA IV classification of anesthesiology risk
  • procedure that lasted longer than 15 minutes
  • indication of therapeutic bronchoscopy
  • cardiac arrhythmia and / or hypoxemia detected at admission.
  Contacts and Locations
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): NCT00440960


Locations
Brazil
Hospital Pompeia
Caxias do Sul, RS, Brazil, 95010-005
Hospital Medianeira
Caxias do Sul, RS, Brazil, 95040-000
General Hospital of Universidade de Caxias do Sul
Caxias do Sul, RS, Brazil, 95070-560
Sponsors and Collaborators
Hospital Pompeia
Investigators
Principal Investigator: Andre GS Leite, PhD Brazilian Society of Thoracic Surgery
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00440960     History of Changes
Other Study ID Numbers: 0002.0.297.000-06
First Submitted: February 26, 2007
First Posted: February 27, 2007
Last Update Posted: February 27, 2007
Last Verified: February 2007

Keywords provided by Hospital Pompeia:
alfentanil
anesthesia
bronchoscopy
lidocaine
midazolam
propofol.

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Lidocaine
Propofol
Midazolam
Alfentanil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators