SedationPhase 4Propofol TCINCT02062177
Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy
A Phase 4 study testing Propofol and Midazolam in people with Sedation and Endoscopy, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Propofol and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age < 18 years
- American Society of Anesthesiologists risk I-II
- patients undergoing to Gastroscopy or Colonoscopy
Who cannot join
- significant systemic disease
- allergic reactions to any of study drugs
- chronic use of opioids or psychiatric disorders
- pregnancy
- Mallampati score > 2
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study
Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).
MidazolamDrug
70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged < 70, 0.03 mg/Kg if aged > 70.
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Experimental | 70 patients (35 upper endoscopy - 35 colonoscopy) Receives: Drug: Propofol |
| midazolam group | Active comparator | 70 patients (35 upper endoscopy - 35 colonoscopy) Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation
Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist
Measured: at the end of the exam
Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge
When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)
Measured: before discharge
Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure
Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)
Measured: at 24-72 hours after procedure
Secondary outcomes (2)
Time (Minutes) to Dischargeability of Patient From Endoscopic Unit
After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.
Measured: one day
Number of Participants With Adverse Events as a Measure of Safety
Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2014
- Study completionMay 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Testoni Pier Alberto, Università Vita-Salute San Raffaele
- Investigators
- Pier Alberto Testoni, Professor, Study director, Vita-Salute San Raffalele University- San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062177
- Sponsor's protocol ID
- Propofol TCI endoscopy
- Acronym
- Propofol TCI
- Status last verified
- Aug 2014
- First submitted
- 3 Feb 2014
- Last updated
- 8 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fanti L, Gemma M, Agostoni M, Rossi G, Ruggeri L, Azzolini ML, Dabizzi E, Beretta L, Testoni PA. Target Controlled Infusion for non-anaesthesiologist propofol sedation during gastrointestinal endoscopy: The first double blind randomized controlled trial. Dig Liver Dis. 2015 Jul;47(7):566-71. doi: 10.1016/j.dld.2015.03.003. Epub 2015 Mar 14.
PubMed 25840875
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study
- ClinicalTrials.gov ID
- NCT02062177
- Acronym / sponsor ID
- Propofol TCI / Propofol TCI endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Posted 8 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol group | Experimental | Drug: Propofol70 patients (35 upper endoscopy - 35 colonoscopy) |
| midazolam group | Active comparator | Drug: Midazolam70 patients (35 upper endoscopy - 35 colonoscopy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age < 18 years
- American Society of Anesthesiologists risk I-II
- patients undergoing to Gastroscopy or Colonoscopy
Key exclusion criteria (6 listed)
- significant systemic disease
- allergic reactions to any of study drugs
- chronic use of opioids or psychiatric disorders
- pregnancy
- Mallampati score > 2
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 |
|---|---|---|
| Propofol70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml). | Drug | propofol group |
| Midazolam70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged < 70, 0.03 mg/Kg if aged > 70. | Drug | midazolam group |
Primary outcome
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation
Time frame: at the end of the exam
Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist
Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge
Time frame: before discharge
When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)
Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure
Time frame: at 24-72 hours after procedure
Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)
2 secondary outcomes
Time (Minutes) to Dischargeability of Patient From Endoscopic Unit
Time frame: one day
Number of Participants With Adverse Events as a Measure of Safety
Time frame: one day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25840875Fanti L, Gemma M, Agostoni M, Rossi G, Ruggeri L, Azzolini ML, Dabizzi E, Beretta L, Testoni PA. Target Controlled Infusion for non-anaesthesiologist propofol sedation during gastrointestinal endoscopy: The first double blind randomized controlled trial. Dig Liver Dis. 2015 Jul;47(7):566-71. doi: 10.1016/j.dld.2015.03.003. Epub 2015 Mar 14.
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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.
Pier Alberto Testoni, Professor study director
Vita-Salute San Raffalele University- San Raffaele 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 Propofol and Midazolam in people with Sedation and Endoscopy, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 3 inclusion and 6 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 8 Sep 2014. 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 Italy. 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.
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 8 Sep 2014). 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?
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation (time frame: at the end of the exam). 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?
On the ClinicalTrials.gov record for NCT02062177, which also lists 1 linked publication.
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 8 Sep 2014.