Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy

Chang Gung Medical Foundation

Status and phase: Completed; Phase 4

Conditions: Hypoxemia

Treatments: Device: Targeted controlled infusion; Drug: Normal saline; Drug: Propofol; Drug: Alfentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01470170

99-1538A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 173 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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173 participants in 5 patient groups, including a placebo group

Group1

Experimental group

Description:

Alfentanil 2.5μg/kg before propofol

Treatment:

Drug: Alfentanil

Device: Targeted controlled infusion

Drug: Normal saline

Drug: Propofol

Group2

Experimental group

Description:

Alfentanil 5μg/kg before propofol

Treatment:

Drug: Alfentanil

Device: Targeted controlled infusion

Drug: Normal saline

Drug: Propofol

Group 3

Experimental group

Description:

Alfentanil 2.5μg/kg two minutes before propofol

Treatment:

Drug: Alfentanil

Device: Targeted controlled infusion

Drug: Normal saline

Drug: Propofol

Group 4

Experimental group

Description:

Alfentanil 5μg/kg two minutes before propofol

Treatment:

Drug: Alfentanil

Device: Targeted controlled infusion

Drug: Normal saline

Drug: Propofol

Group 5 Control

Placebo Comparator group

Description:

propofol alone

Treatment:

Device: Targeted controlled infusion

Drug: Normal saline

Drug: Propofol