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Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
propofol
midazolam
alfentanil
lidocaine
Sponsored by
Hospital Pompeia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring alfentanil, anesthesia, bronchoscopy, lidocaine, midazolam, propofol.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Hospital Pompeia
  • Hospital Medianeira
  • General Hospital of Universidade de Caxias do Sul

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 26, 2007
Last Updated
February 26, 2007
Sponsor
Hospital Pompeia
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1. Study Identification

Unique Protocol Identification Number
NCT00440960
Brief Title
Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Pompeia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
alfentanil, anesthesia, bronchoscopy, lidocaine, midazolam, propofol.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Type
Drug
Intervention Name(s)
alfentanil
Intervention Type
Drug
Intervention Name(s)
lidocaine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre GS Leite, PhD
Organizational Affiliation
Brazilian Society of Thoracic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Pompeia
City
Caxias do Sul
State/Province
RS
ZIP/Postal Code
95010-005
Country
Brazil
Facility Name
Hospital Medianeira
City
Caxias do Sul
State/Province
RS
ZIP/Postal Code
95040-000
Country
Brazil
Facility Name
General Hospital of Universidade de Caxias do Sul
City
Caxias do Sul
State/Province
RS
ZIP/Postal Code
95070-560
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
7842773
Citation
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.
Results Reference
background
PubMed Identifier
11506101
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. doi: 10.1097/00000542-200108000-00011.
Results Reference
result
PubMed Identifier
16211735
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. doi: 10.1017/s0265021505001262.
Results Reference
result
PubMed Identifier
2245677
Citation
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.
Results Reference
result
PubMed Identifier
9560538
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.
Results Reference
result
PubMed Identifier
10735670
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. doi: 10.1016/s0003-4975(99)01398-3.
Results Reference
result
PubMed Identifier
9743396
Citation
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.
Results Reference
result
PubMed Identifier
657853
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. doi: 10.1378/chest.73.6.813.
Results Reference
result
PubMed Identifier
8404160
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. doi: 10.1378/chest.104.4.1029.
Results Reference
result

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Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic

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