NCT01470170

Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hypoxemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2011-11-11
• Last updated: 2015-08-13
• Results posted: 2015-08-13

Locations

1 site across 1 country: Taiwan