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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Experimental | Alfentanil 2.5μg/kg before propofol |
|
| Group2 | Experimental | Alfentanil 5μg/kg before propofol |
|
| Group 3 | Experimental | Alfentanil 2.5μg/kg two minutes before propofol |
|
| Group 4 | Experimental | Alfentanil 5μg/kg two minutes before propofol |
|
| Group 5 Control | Placebo Comparator | propofol alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfentanil | Drug | Give Alfentanil before TCI Propofol sedative bronchoscope |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chung Hsing Hsieh, M.D. | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Taipei | 333 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group1 | Alfentanil 2.5μg/kg immediately before TCI propofol administration |
| FG001 | Group2 | Alfentanil 5μg/kg immediately before TCI propofol administration |
| FG002 | Group 3 | Alfentanil 2.5μg/kg two minutes before TCI propofol administration |
| FG003 | Group 4 | Alfentanil 5μg/kg two minutes before TCI propofol administration |
| FG004 | Group 5 Control | TCI propofol administration alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group1 | alfentanil 2.5ug/kg immediately before propofol |
| BG001 | Group 2 | alfentanil 2.5ug/kg two minutes before propofol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ug/ml | All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours |
|
Before, during, and after the fibro-bronchoscopy procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group1 | alfentanil 2.5ug/kg immediately before propofol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yu-Lun, Lo | Department of Thoracic Medicine | +886-3-3281200 | 5108 | loyulun@hotmail.com |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015760 | Alfentanil |
| D000077330 | Saline Solution |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Normal saline | Drug | Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose. |
|
| Targeted controlled infusion | Device | The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model |
|
| 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 |
|
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 |
| BG002 | Group 3 | alfentanil 5ug/kg immediately before propofol |
| BG003 | Group 4 | alfentanil 5ug/kg two minutes before propofol |
| BG004 | Group 5/ Control | Propofol alone |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anaethesiology Physical Status Score | Number | participants |
|
| Mallampati Score | Number | participants |
|
| Regular use of opioid | use of opioid related medication for more than 5 days per week | Number | participants |
|
| Regular use of sedation drugs | use of sleeping pill or sedative medication for more than 5 days per week | Number | participants |
|
| Alcohol use | alcohol drinking for more than 5 days per week | Number | participants |
|
| smoking status | Number | participants |
|
| heart rate | Mean | Standard Deviation | beats/min |
|
| SBP | Mean | Standard Deviation | mmHg |
|
| DBP | Mean | Standard Deviation | mmHg |
|
| SpO2 | Mean | Standard Deviation | percentage of saturation |
|
| OG002 | Group 3 | alfentanil 5ug/kg immediately before propofol |
| OG003 | Group 4 | alfentanil 5ug/kg two minutes before propofol |
| OG004 | Group 5 /Control | Propofol alone |
|
|
| 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. | Posted | Mean | Standard Deviation | mg | All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours |
|
|
|
| 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. | Posted | Mean | Standard Deviation | second | All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours |
|
|
|
| Secondary | Hypoxemia | Check the frequency of hypoxemia episode during induction, procedure, and recovery time | Posted | Number | participants | All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours |
|
|
|
| Secondary | Hypotension | Check the frequency of hypotension episode during induction, procedure and recovery time | Posted | Number | participants | All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Group 2 | alfentanil 2.5ug/kg two minutes before propofol | 0 | 35 | 0 | 35 |
| EG002 | Group 3 | alfentanil 5ug/kg immediately before propofol | 0 | 34 | 0 | 34 |
| EG003 | Group 4 | alfentanil 5ug/kg two minutes before propofol | 0 | 36 | 0 | 36 |
| EG004 | Group 5 /Control | Propofol alone | 0 | 34 | 0 | 34 |
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| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| Procedure time |
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| Recovery time |
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| Procedure time |
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| Recovery time |
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