Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy
Condition: Hypoxemia
MeSH terms: Hypoxia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Alfentanil; Normal saline; Targeted controlled infusion; Propofol
Intervention type(s): Drug; Drug; Device; Drug
Intervention description(s): Give Alfentanil before TCI Propofol sedative bronchoscope; Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.; The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model; The Propofol dosage is according to the effect site concentration to reach OAAS-3 ( loss of conscious), using TCI Schneider model during the whole procedure of bronchoscope
Intervention MeSH terms: Alfentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Sedative bronchoscope; Alfentanil doses; Propofol; Targeted controlled infusion; Hypoxemia