Clinical trial NCT01470170: Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy
Official title: The Optimal Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy：a Prospective Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypoxemia
Keywords: Sedative bronchoscope
Alfentanil doses
Propofol
Targeted controlled infusion
Hypoxemia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 \< 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

Primary outcomes:
measure: Effect Site Concentration When Conscious Level Reaches OAAS-3
timeFrame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
measure: Propofol Dose Needed to Reach Conscious Level OAAS-3
timeFrame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
measure: Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3
timeFrame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
Secondary outcomes:
measure: Hypoxemia
timeFrame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
measure: Hypotension
timeFrame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chung Hsing Hsieh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: