Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy

The Optimal Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy：a Prospective Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypoxemia
• Intervention / Treatment: Drug: Alfentanil; Drug: Normal saline; Device: Targeted controlled infusion; Drug: Propofol

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.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group1; Alfentanil 2.5μg/kg before propofol	Drug: Alfentanil; Give Alfentanil before TCI Propofol sedative bronchoscope; Drug: Normal saline; Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.; Device: Targeted controlled infusion; The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model; Drug: Propofol; 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
Experimental: Group2; Alfentanil 5μg/kg before propofol	Drug: Alfentanil; Give Alfentanil before TCI Propofol sedative bronchoscope; Drug: Normal saline; Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.; Device: Targeted controlled infusion; The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model; Drug: Propofol; 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
Experimental: Group 3; Alfentanil 2.5μg/kg two minutes before propofol	Drug: Alfentanil; Give Alfentanil before TCI Propofol sedative bronchoscope; Drug: Normal saline; Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.; Device: Targeted controlled infusion; The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model; Drug: Propofol; 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
Experimental: Group 4; Alfentanil 5μg/kg two minutes before propofol	Drug: Alfentanil; Give Alfentanil before TCI Propofol sedative bronchoscope; Drug: Normal saline; Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.; Device: Targeted controlled infusion; The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model; Drug: Propofol; 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
Placebo Comparator: Group 5 Control; propofol alone	Drug: Normal saline; Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.; Device: Targeted controlled infusion; The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model; Drug: Propofol; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect Site Concentration When Conscious Level Reaches OAAS-3	After the administration of alfentanil and propofol, the effect site concentration was recorded at the time when the consciousness level reaches observer assessment of alertness and sedation scale 3 (OAAS-3). The effect site concentration is the concentration of drug propofol in brain calculated by TCI using Schnider model.	All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
Propofol Dose Needed to Reach Conscious Level OAAS-3	After the administration of Alfentanil and Propofol, the Propofol dose needed to reach conscious level of observer assessment of alertness and sedation scale 3 (OAAS-3) will be recorded.	All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3	After the administration of Alfentanil and Propofol, the time period required to reach conscious level OAAS-3 will be recorded.	All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxemia	Check the frequency of hypoxemia episode during induction, procedure, and recovery time	All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
Hypotension	Check the frequency of hypotension episode during induction, procedure and recovery time	All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chung Hsing Hsieh, M.D., Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 27, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (Estimate): November 11, 2011

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 7, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Propofol; Hypoxemia; Sedative bronchoscope; Alfentanil doses; Targeted controlled infusion
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Propofol; Alfentanil
• Other Study ID Numbers: 99-1538A3