Who is sponsoring NCT01470170?

NCT01470170 is sponsored by Chang Gung Memorial Hospital.

What drugs are being tested in NCT01470170?

Interventions: Alfentanil, Normal saline, Targeted controlled infusion, Propofol.

What is the status of NCT01470170?

NCT01470170 is currently COMPLETED.

Last reviewed 2015-08-07 · How we verify

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

NCT01470170 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Chang Gung Memorial Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	173
Start date	2010-10
Completion	2011-12

Conditions

Hypoxemia

Interventions

Alfentanil
Normal saline
Targeted controlled infusion
Propofol

Primary outcomes

Effect Site Concentration When Conscious Level Reaches OAAS-3 — 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.
Propofol Dose Needed to Reach Conscious Level OAAS-3 — 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.
Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3 — 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.

Countries

Taiwan