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NCT Number: NCT01470170

Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy

Alfentanil (Alf) is used in combination with Propofol (Pro) in fiber-bronchoscopy and in many other conscious sedation procedures. Alf and Pro have the characteristic of rapid anesthetic onset and quick recovery, synergic sedative effect and unwanted side effects too. However, the amount of Alf needed in combination with Pro for induction and the timing of administration was no standardized. The investigators designed this study to evaluate the optimal regimen, dose and timing of Alf in Target-Controlled infusion (TCI) of Pro for flexible bronchoscopy sedation, and also to evaluate the influence of variable regimen of Alf and Pro on hypoxemia, hypotension, cough severity, and Pro injection related pain.

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Key information

Conditions

Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chang Gung Memorial Hospital

Taipei, 333, Taiwan

About this study

Alfentanil (Alf) is used in combination with Propofol (Pro) in fiber-bronchoscopy and in many other conscious sedation procedures. Alf and Pro have the characteristic of rapid anesthetic onset and quick recovery, synergic sedative effect and unwanted side effects too. However, the amount of Alf needed in combination with Pro for induction and the timing of administration was no standardized. The investigators designed this study to evaluate the optimal regimen, dose and timing of Alf in Target-Controlled infusion (TCI) of Pro for flexible bronchoscopy sedation.

Method: patients will be enrolled and assigned randomly into five groups. In group 1, normal saline two minutes before and Alf 2.5μg/kg before Pro were given; In group 2, normal saline two minutes before and Alf 5μg/kg before Pro were given; In group 3, Alf 2.5μg/kg two minutes before and normal saline before Pro were given; In group 4: Alf 5μg/kg two minutes before and normal saline before Pro were given; in group 5, normal saline two minutes and before Pro were given.

Concentration of effect site to loss of consciousness (LOC), dose of Pro to LOC, and induction time of variable regimen, as well as hypoxemia, hypotension, cough severity, and Pro injection related pain will be recorded and analyzed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who required elective sedative bronchoscopy

Exclusion criteria

  • any physical, psychiatric, social problem that avoid from conscious level evaluation,
  • hypersensitivity or allergy to Propofol, Alfentanil
  • severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, or requirement for oxygen therapy)
  • unstable haemodynamic status (defined as a heart rate < 60 or ≧ 120 bpm and/or
  • a systolic blood pressure (SBP) < 100 or ≧ 180 mmHg)
  • predictable difficult upper airways (Mallampati classification score of IV)
  • severe obstructive sleep apnea with apnea hypopnea index (AHI) > 45
  • Body mass index (BMI) more than 42 in male and 35 in female
  • renal insufficiency
  • liver cirrhosis

Treatment and study plan

alfentanil

Drug

Give Alfentanil before TCI Propofol sedative bronchoscope

normal saline

Drug

Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.

Targeted controlled infusion

Device

The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model

Propofol

Drug

The Propofol dosage is according to the effect site concentration to reach OAAS-3 ( loss of conscious), using TCI Schneider model during the whole procedure of bronchoscope

Primary outcomes

  1. Effect Site Concentration When Conscious Level Reaches OAAS-3

    Time frame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours

    After the administration of alfentanil and propofol, the effect site concentration was recorded at the time when the consciousness level reaches observer assessment of alertness and sedation scale 3 (OAAS-3). The effect site concentration is the concentration of drug propofol in brain calculated by TCI using Schnider model.

  2. Propofol Dose Needed to Reach Conscious Level OAAS-3

    Time frame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours

    After the administration of Alfentanil and Propofol, the Propofol dose needed to reach conscious level of observer assessment of alertness and sedation scale 3 (OAAS-3) will be recorded.

  3. Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3

    Time frame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours

    After the administration of Alfentanil and Propofol, the time period required to reach conscious level OAAS-3 will be recorded.

Secondary outcomes

  1. Hypoxemia

    Time frame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours

    Check the frequency of hypoxemia episode during induction, procedure, and recovery time

  2. Hypotension

    Time frame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours

    Check the frequency of hypotension episode during induction, procedure and recovery time

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Optimal Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy：a Prospective Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 11, 2011
Registry last updated
Aug 13, 2015

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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