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Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy

NCT01470170 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2015-08-13

Study results available
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Summary

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.

Conditions

  • Hypoxemia

Interventions

DRUG

Alfentanil

Give Alfentanil before TCI Propofol sedative bronchoscope

DRUG

Normal saline

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

DEVICE

Targeted controlled infusion

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

DRUG

Propofol

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

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Chung Hsing Hsieh, M.D. · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01470170 on ClinicalTrials.gov