Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470170
• Other study ID #: 99-1538A3
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2011
• Last updated: August 7, 2015
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: August 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoxemia

Intervention

Drug:
• Alfentanil
Give Alfentanil before TCI Propofol sedative bronchoscope
• 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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes