Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy

NCT01470170 | Completed Phase 4 Results

• 1 other identifier: 99-1538A3
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia

Keywords

Sedative bronchoscope; Alfentanil doses; Propofol; Targeted controlled infusion; Hypoxemia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Hypoxemia

  All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours

• Hypotension

  All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours

Study Arms (5)

Group1

EXPERIMENTAL

Alfentanil 2.5μg/kg before propofol

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

Group2

EXPERIMENTAL

Alfentanil 5μg/kg before propofol

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

Group 3

EXPERIMENTAL

Alfentanil 2.5μg/kg two minutes before propofol

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

Group 4

EXPERIMENTAL

Alfentanil 5μg/kg two minutes before propofol

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

Group 5 Control

PLACEBO COMPARATOR

propofol alone

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

Interventions

Alfentanil DRUG

Give Alfentanil before TCI Propofol sedative bronchoscope

Group 3; Group 4; Group1; Group2

Normal saline DRUG

Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.

Group 3; Group 4; Group 5 Control; Group1; Group2

Targeted controlled infusion DEVICE

The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model

Group 3; Group 4; Group 5 Control; Group1; Group2

Propofol DRUG

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

Group 3; Group 4; Group 5 Control; Group1; Group2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who required elective sedative bronchoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 333, Taiwan

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Alfentanil; Saline Solution; Propofol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Yu-Lun, Lo
• Organization: Department of Thoracic Medicine

loyulun@hotmail.com

+886-3-3281200

Study Officials

• Chung Hsing Hsieh, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical Intensive Care Unit, Department of Internal Medicine, Chang-Gung Memorial Hospital, Taipei

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 11, 2011
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 13, 2015
• Results First Posted: August 13, 2015

Record last verified: 2015-08

Locations

TW (1)