Propofol Versus Midazolam+Alfentanil for Sedation During Bronchoscopy: Comparison by Cutaneous Carbon Dioxide Tension

NCT01289327 | Completed DMC

• 1 other identifier: 5634
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Although propofol is a popular agent for sedation during flexible bronchoscopy, some clinicians have raised concerns that it may cause greater respiratory drive reduction than more common drugs. However, this factor is difficult to accurately examine with pulse oximetry. The introduction of a novel device that noninvasively measures carbon dioxide (CO2) levels can help to resolve this controversy. The aim of this study is to evaluate the safety of conscious sedation with midazolam+alfentanil compared to propofol.

Conditions

Lung Disease

Outcome Measures

Primary Outcomes (4)

• Percutaneous carbon dioxide tension

  Continues measurements (record every 4 second)

  From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes)

• oxygen saturation

  Continues measurements (record every 4 second)

  From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes)

• heart rate

  Continues measurements (record every 4 second)

  From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes)

• non invasive blood pressure

  every 5 minutes

  From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes)

Secondary Outcomes (3)

• A questionnaire evaluating pain and discomfort

  ~30 minutes after the end of the procedure

• Oxygen supplementation

  From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes)

• Naso/oropharyngeal tube insertion

  From the beginning of fiberoptic bronchoscopy until 10 minutes after the end of the procedure (average time of fiberoptic bronchoscopy ~ 15 minutes)

Study Arms (2)

propofol

ACTIVE COMPARATOR

Drug: Sedation with Propofol or Midazolam+Alfentanil for FFB

midazolam+alfentanil

ACTIVE COMPARATOR

Drug: Sedation with Propofol or Midazolam+Alfentanil for FFB

Interventions

Sedation with Propofol or Midazolam+Alfentanil for FFB DRUG

Sedation was started with intravenous injection of a bolus of 2-4 mg midazolam and 0.5 mg alfentanil or 20-50 mg propofol. It was maintained with intermittent boluses of 1-3 mg intravenous midazolam or 0.5 mg intravenous alfentanil, according to clinical judgment, or with boluses of 10-20 mg intravenous propofol, administered at short intervals (\~2 minutes) or according to clinical judgment.

Also known as: diprivan, midazolam, alfentanil

midazolam+alfentanil; propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study group consisted of patients scheduled for flexible bronchoscopy under local anesthesia with sedation at a tertiary medical center.

You may not qualify if:

• Inability or refusal to provide informed consent, age less than 18 years, bronchoscopy through an artificial airway, and allergy to soya or to one of the sedative drugs.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical center, Beilinson Hospital

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Propofol; Midazolam; Alfentanil

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mordechai R Kramer, MD,Professor

  Head, Pulmonary Institute , Rabin Medical center, Beilinson Hospital, Petach Tikva, 49100 Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2011
• First Posted: February 3, 2011
• Study Start: April 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 3, 2011

Record last verified: 2010-12

Locations

IL (1)