Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic - Full Text View

Sponsor:	Hospital Pompeia
Information provided by:	Hospital Pompeia
ClinicalTrials.gov Identifier:	NCT00440960

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Factorial Assignment

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Cancer Lung Cancer

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride Alfentanil hydrochloride Alfentanil Lidocaine Propofol

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440960

Locations

Brazil, RS
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:

Barr J, Egan TD, Sandoval NF, Zomorodi K, Cohane C, Gambus PL, Shafer SL. Propofol dosing regimens for ICU sedation based upon an integrated pharmacokinetic-pharmacodynamic model. Anesthesiology. 2001 Aug;95(2):324-33.

Schaeuble J, Heidegger T, Gerig HJ, Ulrich B, Schnider TW. Comparision of etomidate and propofol for fibreoptic intubation as part of an airway management algorithm:a prospective, randomizes, double-blind study. Eur J Anaesthesiol. 2005 Oct;22(10):762-7.

Amitai Y, Zylber-Katz E, Avital A, Zangen D, Noviski N. Serum lidocaine concentrations in children during bronchoscopy with topical anesthesia. Chest. 1990 Dec;98(6):1370-3.

Koyama S, Koh H, Noda K, Tagami N, Asada A. [A comparison of the incidence of postoperative nausea and vomiting after propofol-fentanyl anesthesia and that after nitrous oxide-isoflurane anesthesia] Masui. 1998 Mar;47(3):286-9. Japanese.

Hautmann H, Bauer M, Pfeifer KJ, Huber RM. Flexible bronchoscopy: a safe method for metal stent implantation in bronchial disease. Ann Thorac Surg. 2000 Feb;69(2):398-401.

Cartwright CR, Henson LC, Ward DS. Effects of alfentanil on the ventilatory response to sustained hypoxia. Anesthesiology. 1998 Sep;89(3):612-9.

Pereira W Jr, Kovnat DM, Snider GL. A prospective cooperative study of complications following flexible fiberoptic bronchoscopy. Chest. 1978 Jun;73(6):813-6.

Clarkson K, Power CK, O'Connell F, Pathmakanthan S, Burke CM. A comparative evaluation of propofol and midazolam as sedative agents in fiberoptic bronchoscopy. Chest. 1993 Oct;104(4):1029-31.

Pue CA, Pacht ER. Complications of fiberoptic bronchoscopy at a university hospital. Chest. 1995 Feb;107(2):430-2.

Study ID Numbers:	0002.0.297.000-06
Study First Received:	February 26, 2007
Last Updated:	February 26, 2007
ClinicalTrials.gov Identifier:	NCT00440960 History of Changes
Health Authority:	Brazil: Ministry of Health

Keywords provided by Hospital Pompeia:

alfentanil
anesthesia
bronchoscopy

lidocaine
midazolam
propofol.

Additional relevant MeSH terms:

Thoracic Neoplasms
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anti-Arrhythmia Agents
Analgesics

Propofol
Analgesics, Opioid
Anesthetics, Intravenous
Respiratory Tract Neoplasms
Tranquilizing Agents
Lidocaine
Central Nervous System Depressants
Narcotics
Alfentanil
Cardiovascular Agents
Midazolam
Anesthetics, Local
Pharmacologic Actions
Adjuvants, Anesthesia
Neoplasms

ClinicalTrials.gov processed this record on November 05, 2009