SedationNCT03172078
Sedation of Advanced Endoscopic Procedure
A study testing advanced endoscopic procedure in people with Sedation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To evaluate the impacts of target-control infusion (TCI) and bispectral index (BIS) monitoring during advanced endoscopic procedure. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sedation
- What is being tested?
- advanced endoscopic procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jun 2017to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergo advanced endoscopic procedure
Who cannot join
- age less than 20 years, pregnant and lactating women, American Society of Anesthesiologists (ASA) class V, allergy to propofol, benzodiazepine, or opioid, and a requirement for general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Target-controlled Infusion and Bispectral Index Monitoring in Sedation of Advanced Endoscopic Procedure
To evaluate the impacts of target-control infusion (TCI) and bispectral index (BIS) monitoring during advanced endoscopic procedure.
Read the detailed description
Anesthesia requirements for advanced endoscopic procedures are approaching those of specialized surgical interventions. Although many other sedative agents are used prior to and during endoscopy, none approach propofol in terms of desirable properties. The risk of propofol sedation for interventional procedures such as endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), and therapeutic endoscopy are among the highest for any sedated endoscopic procedure. The reasons are many: the intensity of stimulation encountered during these procedures is similar to many minor surgeries; the airway management is complex and requires constant attention; the incidence of hypoxemia is high, and the time available for recognition and management is limited. In order to reap the benefits of advanced endoscopic procedures, anesthesiologists must rise to the challenge. This requires a dedicated anesthetic team practicing safe, efficient, and effective sedation techniques for advanced endoscopic procedures. Ongoing research into novel infusion methods can add safety to the existing sedation techniques and address some of the concerns related to sedative quality. This is a randomized controlled and prospective study. To evaluate the benefits when we use target-controlled infusion of propofol (TCI) with/without bispectral index monitoring in patients undergoing advanced endoscopic procedure. The primary outcome is the total amount of propofol. The secondary outcomes are patients' and endoscopists' satisfaction, sedative-related adverse events, recovery time.
- Conditions
- Sedation
- Being tested
- advanced endoscopic procedure
- Keywords
- advanced endoscopic procedure, ERCP, EUS, target-controlled infusion, sedation, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
advanced endoscopic procedureProcedure or surgery
The advanced endoscopic procedure include endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP), and other upper gastrointestinal endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Target-control infusion without bispectral index monitoring | Active comparator | Target-control infusion (TCI) with propofol during advanced endoscopic procedure e.g. endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP) Receives: Procedure: advanced endoscopic procedure |
| Target-control infusion with bispectral index monitoring | Active comparator | Target-control infusion (TCI) with propofol and BIS monitoring during advanced endoscopic procedure e.g. endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP) Receives: Procedure: advanced endoscopic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
propofol dose
Total amount of propofol during the procedure
Measured: during the endoscopic procedure
Secondary outcomes (3)
sedation-related adverse events
hypotension, hypoxemia
Measured: during the endoscopic procedure
Quality of sedation
The satisfaction of the endoscopist with the sedation is evaluated by a case-by-case questionnaire. Four classes of response: excellent, good, acceptable and poor, were defined for the overall evaluation with the safety of endoscopy procedure, patient cooperation and fluency of the procedure in the opinion of the endoscopist. Patients' satisfaction includes their immediate evaluation of side effects such as post procedure dizziness, nausea/vomiting, or pain recall evaluation in the recovery room. Telephone interviews are performed to ascertain the patients' overall satisfaction evaluation and of the procedure with four classes of responses: excellent, good, acceptable and poor.
Measured: 2 days
Recovery: open eye, conscious clear, discharge time
Recovery data include time from end of endoscopy until eye opening on command and time from end of endoscopy until leaving the recovery room based on Aldrete score ≧ 9.
Measured: within 2 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start5 Jun 2017
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LIN, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172078
- Sponsor's protocol ID
- 201612218RINC
- Status last verified
- Aug 2018
- First submitted
- 23 May 2017
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Target-controlled Infusion and Bispectral Index Monitoring in Sedation of Advanced Endoscopic Procedure
- ClinicalTrials.gov ID
- NCT03172078
- Acronym / sponsor ID
- 201612218RINC
- Conditions
- Sedation
- Keywords
- advanced endoscopic procedure, ERCP, EUS, target-controlled infusion, sedation, propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the impacts of target-control infusion (TCI) and bispectral index (BIS) monitoring during advanced endoscopic procedure.
Detailed description
Anesthesia requirements for advanced endoscopic procedures are approaching those of specialized surgical interventions. Although many other sedative agents are used prior to and during endoscopy, none approach propofol in terms of desirable properties. The risk of propofol sedation for interventional procedures such as endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), and therapeutic endoscopy are among the highest for any sedated endoscopic procedure. The reasons are many: the intensity of stimulation encountered during these procedures is similar to many minor surgeries; the airway management is complex and requires constant attention; the incidence of hypoxemia is high, and the time available for recognition and management is limited. In order to reap the benefits of advanced endoscopic procedures, anesthesiologists must rise to the challenge. This requires a dedicated anesthetic team practicing safe, efficient, and effective sedation techniques for advanced endoscopic procedures. Ongoing research into novel infusion methods can add safety to the existing sedation techniques and address some of the concerns related to sedative quality. This is a randomized controlled and prospective study. To evaluate the benefits when we use target-controlled infusion of propofol (TCI) with/without bispectral index monitoring in patients undergoing advanced endoscopic procedure. The primary outcome is the total amount of propofol. The secondary outcomes are patients' and endoscopists' satisfaction, sedative-related adverse events, recovery time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Target-control infusion without bispectral index monitoring | Active comparator | Procedure: advanced endoscopic procedureTarget-control infusion (TCI) with propofol during advanced endoscopic procedure e.g. endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP) |
| Target-control infusion with bispectral index monitoring | Active comparator | Procedure: advanced endoscopic procedureTarget-control infusion (TCI) with propofol and BIS monitoring during advanced endoscopic procedure e.g. endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergo advanced endoscopic procedure
Key exclusion criteria (1 listed)
- age less than 20 years, pregnant and lactating women, American Society of Anesthesiologists (ASA) class V, allergy to propofol, benzodiazepine, or opioid, and a requirement for general anesthesia
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 |
|---|---|---|
| advanced endoscopic procedureThe advanced endoscopic procedure include endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP), and other upper gastrointestinal endoscopy. | Procedure or surgery | Target-control infusion with bispectral index monitoring, Target-control infusion without bispectral index monitoring |
Primary outcome
propofol dose
Time frame: during the endoscopic procedure
Total amount of propofol during the procedure
3 secondary outcomes
sedation-related adverse events
Time frame: during the endoscopic procedure
Quality of sedation
Time frame: 2 days
Recovery: open eye, conscious clear, discharge time
Time frame: within 2 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: No
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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.
LIN principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing advanced endoscopic procedure in people with Sedation, run by National Taiwan University 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 1 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 3 May 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
propofol dose (time frame: during the endoscopic procedure). 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 3 May 2019.