- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00440960
Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic
February 26, 2007 updated by: Hospital Pompeia
The objective of the study was to establish which anesthetic procedure used during flexible bronchoscopy has the lowest index of complications.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
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Caxias do Sul, RS, Brazil, 95010-005
- Hospital Pompeia
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Caxias do Sul, RS, Brazil, 95040-000
- Hospital Medianeira
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Caxias do Sul, RS, Brazil, 95070-560
- General Hospital of Universidade de Caxias do Sul
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andre GS Leite, PhD, Brazilian Society of Thoracic Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1016/s0003-4975(99)01398-3.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 26, 2007
First Submitted That Met QC Criteria
February 26, 2007
First Posted (Estimate)
February 27, 2007
Study Record Updates
Last Update Posted (Estimate)
February 27, 2007
Last Update Submitted That Met QC Criteria
February 26, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Midazolam
- Propofol
- Lidocaine
- Alfentanil
Other Study ID Numbers
- 0002.0.297.000-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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