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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01470170

Enrollment

173

Registered

2011-11-11

Start date

2010-10-31

Completion date

2011-12-31

Last updated

2015-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia

Keywords

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

Brief summary

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.

Interventions

DRUGAlfentanil

Give Alfentanil before TCI Propofol sedative bronchoscope

DRUGNormal saline

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

DEVICETargeted controlled infusion

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

DRUGPropofol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Effect Site Concentration When Conscious Level Reaches OAAS-3	All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours	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.
Propofol Dose Needed to Reach Conscious Level OAAS-3	All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours	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.
Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3	All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours	After the administration of Alfentanil and Propofol, the time period required to reach conscious level OAAS-3 will be recorded.

Secondary

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

Countries

Taiwan

Participant flow

Participants by arm

Arm	Count
Group1 alfentanil 2.5ug/kg immediately before propofol	34
Group 2 alfentanil 2.5ug/kg two minutes before propofol	35
Group 3 alfentanil 5ug/kg immediately before propofol	34
Group 4 alfentanil 5ug/kg two minutes before propofol	36
Group 5/ Control Propofol alone	34
Total	173

Baseline characteristics

Characteristic	Total	Group 5/ Control	Group1	Group 4	Group 3	Group 2
Age, Continuous	60.5 years STANDARD_DEVIATION 12.1	62.2 years STANDARD_DEVIATION 11.1	60.3 years STANDARD_DEVIATION 11.9	60.9 years STANDARD_DEVIATION 13.9	58.8 years STANDARD_DEVIATION 13	60.3 years STANDARD_DEVIATION 15.8
Alcohol use	17 participants	4 participants	3 participants	5 participants	1 participants	4 participants
American Society of Anaethesiology Physical Status Score 1 Normally healthy	108 participants	24 participants	19 participants	19 participants	23 participants	23 participants
American Society of Anaethesiology Physical Status Score 2 Discrete systemic disease	35 participants	6 participants	7 participants	10 participants	7 participants	5 participants
American Society of Anaethesiology Physical Status Score 3 Serious, non-incapacitating systemic disease	30 participants	4 participants	8 participants	7 participants	4 participants	7 participants
Body Mass Index	23.54 kg/m^2 STANDARD_DEVIATION 3.5	23.2 kg/m^2 STANDARD_DEVIATION 3.7	23.7 kg/m^2 STANDARD_DEVIATION 2.4	23.5 kg/m^2 STANDARD_DEVIATION 3.3	23.8 kg/m^2 STANDARD_DEVIATION 4.5	23.5 kg/m^2 STANDARD_DEVIATION 3.4
DBP	79.2 mmHg STANDARD_DEVIATION 12.2	80.2 mmHg STANDARD_DEVIATION 11.4	80.8 mmHg STANDARD_DEVIATION 12.7	79.5 mmHg STANDARD_DEVIATION 12.1	76.9 mmHg STANDARD_DEVIATION 11.8	78.7 mmHg STANDARD_DEVIATION 13.5
heart rate	78.6 beats/min STANDARD_DEVIATION 14.4	80.2 beats/min STANDARD_DEVIATION 11.4	80.3 beats/min STANDARD_DEVIATION 15.5	80.3 beats/min STANDARD_DEVIATION 14.5	73.9 beats/min STANDARD_DEVIATION 14.2	78.1 beats/min STANDARD_DEVIATION 12.6
Mallampati Score III: soft palate, base of uvula visible	82 participants	15 participants	14 participants	21 participants	16 participants	16 participants
Mallampati Score II: soft palate, uvula, fauces visible	65 participants	12 participants	16 participants	10 participants	14 participants	13 participants
Mallampati Score I: soft palate, uvula, fauces, pillars visible	26 participants	7 participants	4 participants	5 participants	4 participants	6 participants
Regular use of opioid	3 participants	0 participants	1 participants	0 participants	1 participants	1 participants
Regular use of sedation drugs	17 participants	3 participants	3 participants	5 participants	4 participants	2 participants
SBP	142.9 mmHg STANDARD_DEVIATION 21.5	145.8 mmHg STANDARD_DEVIATION 20.5	147.1 mmHg STANDARD_DEVIATION 24.3	142.4 mmHg STANDARD_DEVIATION 21.5	139.2 mmHg STANDARD_DEVIATION 20.8	139.9 mmHg STANDARD_DEVIATION 20.5
Sex: Female, Male Female	70 Participants	13 Participants	15 Participants	12 Participants	17 Participants	13 Participants
Sex: Female, Male Male	103 Participants	21 Participants	19 Participants	24 Participants	17 Participants	22 Participants
smoking status current	44 participants	6 participants	7 participants	11 participants	8 participants	12 participants
smoking status ex-	31 participants	8 participants	7 participants	6 participants	5 participants	5 participants
smoking status never	98 participants	20 participants	20 participants	19 participants	21 participants	18 participants
SpO2	98.9 percentage of saturation STANDARD_DEVIATION 1.4	99.1 percentage of saturation STANDARD_DEVIATION 1.5	98.8 percentage of saturation STANDARD_DEVIATION 1.5	99.2 percentage of saturation STANDARD_DEVIATION 1.3	99.0 percentage of saturation STANDARD_DEVIATION 1.4	98.6 percentage of saturation STANDARD_DEVIATION 1.5

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 34	0 / 35	0 / 34	0 / 36	0 / 34
serious Total, serious adverse events	0 / 34	0 / 35	0 / 34	0 / 36	0 / 34

Outcome results

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.