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Completed

NCT Number: NCT01289327

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical center, Beilinson Hospital

Petah Tikva, 49100, Israel

About this study

Methods: The study group included 115 patients undergoing flexible fiberoptic bronchoscopy(FFB). Patients were randomly assigned by a computer before the procedure to receive sedation with midazolam+alfentanil or propofol. Local anesthesia was induced by application of 2% lidocaine to the oropharynx. 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.

In all cases, monitoring included continuous electrocardiography, pulse oximetry, and automated noninvasive blood pressure recordings every 5 minutes. In addition, percutaneous carbon dioxide tension (PcCO2) was measured with a cutaneous digital sensor (Sentec AG, Therwil, Switzerland) that was placed on the earlobe prior to the procedure. It was removed when the patient left the bronchoscopy suite.

During the procedure, all patients received supplemental nasal oxygen at 2-5 L min-1. Significant hypoxemia, defined as functional oxygen saturation (SpO2) of 90%, was treated initially with jaw support. If it lasted more than few seconds, a naso/oropharyngeal tube was inserted or supplemental oxygen was delivered via face mask at 10 L min-1. The duration of bronchoscopy was calculated from the administration of sedation until the flexible bronchoscope was removed from the tracheobronchial tree.

Percutaneous carbon dioxide tension, blood oxygenation, heart rate, and blood pressure were compared between the groups.

A questionnaire evaluating pain and discomfort by Visual Analog Scale was completed by the patient when awake after the procedure.(~30 minutes after the end of the procedure

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: diprivan, midazolam, alfentanil

Primary outcomes

  1. Percutaneous carbon dioxide tension

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

    Continues measurements (record every 4 second)

  2. oxygen saturation

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

    Continues measurements (record every 4 second)

  3. heart rate

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

    Continues measurements (record every 4 second)

  4. non invasive blood pressure

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

    every 5 minutes

Secondary outcomes

  1. A questionnaire evaluating pain and discomfort

    Time frame: ~30 minutes after the end of the procedure

    A questionnaire evaluating pain and discomfort by Visual Analog Scale was completed by the patient when awake after the procedure.(~30 minutes after the end of the procedure)

  2. Oxygen supplementation

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

    Significant hypoxemia, defined as functional SpO2 of 90%, was treated initially with jaw support. If it lasted more than few seconds, a naso/oropharyngeal tube was inserted or supplemental oxygen was delivered via face mask at 10 L min-1.

    The percentage of patients who needed supplemental oxygen was evaluated

  3. Naso/oropharyngeal tube insertion

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

    Significant hypoxemia, defined as functional SpO2 of 90%, was treated initially with jaw support. If it lasted more than few seconds, a naso/oropharyngeal tube was inserted or supplemental oxygen was delivered via face mask at 10 L min-1

    The percentage of patients who needed Naso/oropharyngeal tube insertion was evaluated

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

Propofol Versus Midazolam Plus Alfentanil for Sedation During Flexible Bronchoscopy: Respiratory Depression Comparison Inspected by Cutaneous Carbon Dioxide Tension Level

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Feb 3, 2011
Registry last updated
Feb 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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