Phase 4
N=173
Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy
Hypoxemia
Bottom Line
View on ClinicalTrials.gov: NCT01470170 ↗Enrolled (actual)
173
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Effect Site Concentration When Conscious Level Reaches OAAS-3 — 2.3; 2.2; 2.5; 2.2 ug/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Alfentanil (Drug); Normal saline (Drug); Targeted controlled infusion (Device); Propofol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect Site Concentration When Conscious Level Reaches OAAS-3 |
2.3; 2.2; 2.5; 2.2; 2.6 | — |
| PRIMARY Propofol Dose Needed to Reach Conscious Level OAAS-3 |
67.8; 56.4; 75.3; 54.8; 76.3 | — |
| PRIMARY Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3 |
279; 263; 374; 247; 402 | — |
| SECONDARY Hypoxemia |
1; 9; 1; 6; 1; 13 | — |
| SECONDARY Hypotension |
2; 1; 0; 0; 0; 7 | — |
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.
Eligibility 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 45
- Body mass index (BMI) more than 42 in male and 35 in female
- renal insufficiency
- liver cirrhosis
Data sourced from ClinicalTrials.gov (NCT01470170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.