HypoxemiaPhase 4NCT01470170
Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy
A Phase 4 study testing Alfentanil, Normal saline and Propofol in people with Hypoxemia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Alfentanil, Normal saline and Propofol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2010to Dec 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who required elective sedative bronchoscopy
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfentanilDrug
Give Alfentanil before TCI Propofol sedative bronchoscope
Normal salineDrug
Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.
Targeted controlled infusionDevice
The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model
PropofolDrug
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 group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | Alfentanil 2.5μg/kg before propofol Receives: Drug: Alfentanil; Drug: Normal saline; Device: Targeted controlled infusion; Drug: Propofol |
| Group2 | Experimental | Alfentanil 5μg/kg before propofol Receives: Drug: Alfentanil; Drug: Normal saline; Device: Targeted controlled infusion; Drug: Propofol |
| Group 3 | Experimental | Alfentanil 2.5μg/kg two minutes before propofol Receives: Drug: Alfentanil; Drug: Normal saline; Device: Targeted controlled infusion; Drug: Propofol |
| Group 4 | Experimental | Alfentanil 5μg/kg two minutes before propofol Receives: Drug: Alfentanil; Drug: Normal saline; Device: Targeted controlled infusion; Drug: Propofol |
| Group 5 Control | Placebo comparator | propofol alone Receives: Drug: Normal saline; Device: Targeted controlled infusion; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
Secondary outcomes (2)
Hypoxemia
Check the frequency of hypoxemia episode during induction, procedure, and recovery time
Measured: 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
Measured: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung-Hsing, Hsieh, Chang Gung Memorial Hospital
- Investigators
- Chung Hsing Hsieh, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470170
- Sponsor's protocol ID
- 99-1538A3
- Status last verified
- Aug 2015
- First submitted
- 27 Oct 2011
- Last updated
- 13 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy：a Prospective Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01470170
- Acronym / sponsor ID
- 99-1538A3
- Conditions
- Hypoxemia
- Keywords
- Sedative bronchoscope, Alfentanil doses, Propofol, Targeted controlled infusion, Hypoxemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Posted 13 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Drug: Alfentanil, Drug: Normal saline, Device: Targeted controlled infusion, Drug: PropofolAlfentanil 2.5μg/kg before propofol |
| Group2 | Experimental | Drug: Alfentanil, Drug: Normal saline, Device: Targeted controlled infusion, Drug: PropofolAlfentanil 5μg/kg before propofol |
| Group 3 | Experimental | Drug: Alfentanil, Drug: Normal saline, Device: Targeted controlled infusion, Drug: PropofolAlfentanil 2.5μg/kg two minutes before propofol |
| Group 4 | Experimental | Drug: Alfentanil, Drug: Normal saline, Device: Targeted controlled infusion, Drug: PropofolAlfentanil 5μg/kg two minutes before propofol |
| Group 5 Control | Placebo comparator | Drug: Normal saline, Device: Targeted controlled infusion, Drug: Propofolpropofol alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who required elective sedative bronchoscopy
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlfentanilGive Alfentanil before TCI Propofol sedative bronchoscope | Drug | Group 3, Group 4, Group1, Group2 |
| Normal salineNormal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose. | Drug | Group 3, Group 4, Group 5 Control, Group1, Group2 |
| Targeted controlled infusionThe Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model | Device | Group 3, Group 4, Group 5 Control, Group1, Group2 |
| PropofolThe 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 | Drug | Group 3, Group 4, Group 5 Control, Group1, Group2 |
Primary outcome
Effect Site Concentration When Conscious Level Reaches OAAS-3
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Hypoxemia
Time frame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
Hypotension
Time frame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung Hsing Hsieh, M.D. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfentanil, Normal saline and Propofol in people with Hypoxemia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect Site Concentration When Conscious Level Reaches OAAS-3 (time frame: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.