Lung CancerPhase 4NCT00440960
Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic
A Phase 4 study testing propofol, midazolam and alfentanil in people with Lung Cancer, run by Hospital Pompeia at 3 sites in Brazil.
Trial summary
The objective of the study was to establish which anesthetic procedure used during flexible bronchoscopy has the lowest index of complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- propofol, midazolam and alfentanil
- How many people
- Not given
- Where
- 3 sitesBrazil
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Hospital Pompeia
Caxias do Sul, Rio Grande do Sul, 95010-005
Hospital Medianeira
Caxias do Sul, Rio Grande do Sul, 95040-000
General Hospital of Universidade de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, 95070-560
About this study
The objective of the study was to establish which anesthetic procedure used during flexible bronchoscopy has the lowest index of complications.
Read the 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.
- Conditions
- Lung Cancer
- Keywords
- alfentanil, anesthesia, bronchoscopy, lidocaine, midazolam, propofol.
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Hospital Pompeia
- Sponsor type
- University, hospital or other
- Investigators
- Andre GS Leite, PhD, Principal investigator, Brazilian Society of Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440960
- Sponsor's protocol ID
- 0002.0.297.000-06
- Status last verified
- Feb 2007
- First submitted
- 26 Feb 2007
- Last updated
- 27 Feb 2007
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 7842773Barr 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.
PubMed 11506101Schaeuble 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.
PubMed 16211735Amitai 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.
PubMed 2245677Koyama 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.
PubMed 9560538Hautmann 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.
PubMed 10735670Cartwright 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.
PubMed 9743396Pereira 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.
PubMed 657853Clarkson 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.
PubMed 8404160
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic
- ClinicalTrials.gov ID
- NCT00440960
- Acronym / sponsor ID
- 0002.0.297.000-06
- Conditions
- Lung Cancer
- Keywords
- alfentanil, anesthesia, bronchoscopy, lidocaine, midazolam, propofol.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hospital PompeiaUniversity, hospital or other
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol | Drug | – |
| midazolam | Drug | – |
| alfentanil | Drug | – |
| lidocaine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2007.
- Background: PubMed 7842773Pue 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 publication: PubMed 11506101Barr 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 publication: PubMed 16211735Schaeuble 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 publication: PubMed 2245677Amitai 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 publication: PubMed 9560538Koyama 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 publication: PubMed 10735670Hautmann 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 publication: PubMed 9743396Cartwright 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 publication: PubMed 657853Pereira 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 publication: PubMed 8404160Clarkson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre GS Leite, PhD principal investigator
Brazilian Society of Thoracic Surgery
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol, midazolam and alfentanil in people with Lung Cancer, run by Hospital Pompeia at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00440960, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2007.