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Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic

NCT ID: NCT00440960

Last Updated: 2007-02-27

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

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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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.

Conditions

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Lung Cancer

Keywords

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alfentanil anesthesia bronchoscopy lidocaine midazolam propofol.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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propofol

Intervention Type DRUG

midazolam

Intervention Type DRUG

alfentanil

Intervention Type DRUG

lidocaine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Pompeia

OTHER

Sponsor Role lead

Principal Investigators

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Andre GS Leite, PhD

Role: PRINCIPAL_INVESTIGATOR

Brazilian Society of Thoracic Surgery

Locations

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Hospital Pompeia

Caxias do Sul, Rio Grande do Sul, Brazil

Site Status

Hospital Medianeira

Caxias do Sul, Rio Grande do Sul, Brazil

Site Status

General Hospital of Universidade de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Pue CA, Pacht ER. Complications of fiberoptic bronchoscopy at a university hospital. Chest. 1995 Feb;107(2):430-2. doi: 10.1378/chest.107.2.430.

Reference Type BACKGROUND
PMID: 7842773 (View on PubMed)

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. doi: 10.1097/00000542-200108000-00011.

Reference Type RESULT
PMID: 11506101 (View on PubMed)

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. doi: 10.1017/s0265021505001262.

Reference Type RESULT
PMID: 16211735 (View on PubMed)

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. doi: 10.1378/chest.98.6.1370.

Reference Type RESULT
PMID: 2245677 (View on PubMed)

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.

Reference Type RESULT
PMID: 9560538 (View on PubMed)

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. doi: 10.1016/s0003-4975(99)01398-3.

Reference Type RESULT
PMID: 10735670 (View on PubMed)

Cartwright CR, Henson LC, Ward DS. Effects of alfentanil on the ventilatory response to sustained hypoxia. Anesthesiology. 1998 Sep;89(3):612-9. doi: 10.1097/00000542-199809000-00009.

Reference Type RESULT
PMID: 9743396 (View on PubMed)

Pereira W Jr, Kovnat DM, Snider GL. A prospective cooperative study of complications following flexible fiberoptic bronchoscopy. Chest. 1978 Jun;73(6):813-6. doi: 10.1378/chest.73.6.813.

Reference Type RESULT
PMID: 657853 (View on PubMed)

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. doi: 10.1378/chest.104.4.1029.

Reference Type RESULT
PMID: 8404160 (View on PubMed)

Other Identifiers

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0002.0.297.000-06

Identifier Type: -

Identifier Source: org_study_id