Overview

Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy

Status:
Completed

Trial end date:
2011-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chang Gung Memorial Hospital

Treatments:

Alfentanil
Hypnotics and Sedatives
Propofol

Criteria

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