Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440960
• Other study ID #: 0002.0.297.000-06
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2007
• Last updated: February 26, 2007

Study information

• Verified date: February 2007
• Source: Hospital Pompeia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The objective of the study was to establish which anesthetic procedure used during flexible bronchoscopy has the lowest index of complications.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Drug:
• propofol

• midazolam

• alfentanil

• lidocaine

Locations

Country	Name	City	State
Brazil	General Hospital of Universidade de Caxias do Sul	Caxias do Sul	RS
Brazil	Hospital Medianeira	Caxias do Sul	RS
Brazil	Hospital Pompeia	Caxias do Sul	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Pompeia

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation