PropofolPhase 4PropTCI/2012NCT01941888
Propofol TCI Administered by Gastroenterologists During Endoscopy: a Randomized Double Blind Controlled Study
A Phase 4 study testing Propofol and Midazolam in people with Propofol and Target Controlled Infusion, run by Ospedale San Raffaele at 2 sites in Italy.
Trial summary
Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI 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
- Conditions the study is for
- Propofol, Target Controlled Infusion, Moderate Sedation
- What is being tested?
- Propofol and Midazolam
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesItaly
- Study dates
- May 2012to Mar 2013
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 yrs
- ASA (American Society of Anesthesiologists risk class III-IV)I-II
- patients undergoing to gastroscopy or colonoscopy
Who cannot join
- significant systemic disease (American Society of Anesthesiologists risk class III-IV)
- history of allergic reactions to any of the study drugs
- chronic use of opioid analgesics
- psychiatric disorder
- pregnancy
- difficult airways (Mallampati score >2)
- age <18 yrs
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
San Raffaele Hospital
Milan, Milan, 20132
San Raffaele Hospital
Milan
About this study
Official title: Phase IV Study of Propofol TCI (Target Controlled Infusion)Administered by Gastroenterologists During Endoscopy in Moderate Sedation: a Randomized Double Blind Controlled Study
Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation.
This randomized double blind controlled study compares standard moderate sedation level of sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS (group P).
Read the detailed description
70 CS and 70 EGD ASA I-II patients were studied. In group S (n=70) we administered fentanyl (1μg/kg) + midazolam (0.04-0.03 mg/kg) for CS and midazolam (0.04-0.03 mg/kg) for EGDS and in group P (n=70) fentanyl 1µg/Kg + propofol TCI 1.2-1.6 μg/ml for CS and propofol TCI 1.2-1.6 μg/ml for EGD. Vital parameters and Observer's Assessment of Alertness and Sedation Scale (OAA/S) were monitored throughout the study. Endoscopist's and patient's satisfactions were measured after procedure and 24-72 h later by visual analog scale (VAS).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| propofol | Experimental | Patients in Group Propofol(n=70) were seated with propofol target concentration 1.2-1.6 µg/ml. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control. Receives: Drug: Propofol; Device: Target Controlled Infusion |
| midazolam | Active comparator | Control Group: patients in Group midazolam (n=70) were sedated with midazolam 0.04 mg/kg if aged< 70 - 0.03 mg/kg if aged> 70. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation
Endoscopist's satisfaction was measured after endoscopic procedures by visual analog scale (VAS 0-100).
Measured: one day
Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation
Patient's satisfactions were measured after endoscopic procedures and 24-48 hours later by visual analog scale (VAS 0-100).
Measured: one day
Secondary outcomes (2)
Safety (number of partecipants with adverse events) of propofol TCI moderate sedation
To compare safety (number of partecipants with adverse events) of propofol TCI versus midazolam iv boluses during upper endoscopy (EGD) and colonoscopy (CS). Both sedation regimens were administered by endoscopists.
Measured: one day
Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients
To compare time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients in group standard versus propofol TCI group
safety (number of partecipants with adverse events) of propofol TCI versus midazolam iv boluses during upper endoscopy (EGD) and colonoscopy (CS). Both sedation regimens were administered by endoscopists.
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 Sep 2013 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PropofolStudies 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, Care provider
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agostoni Massimo, Ospedale San Raffaele
- Investigators
- Massimo Agostoni, MD, Study director, San Raffele HospitalLorella Fanti, MD, Principal investigator, San Raffaele HospitalMarco Gemma, MD, Principal investigator, San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941888
- Sponsor's protocol ID
- PropTCI2012
- Acronym
- PropTCI/2012
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2013
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Propofol TCI (Target Controlled Infusion)Administered by Gastroenterologists During Endoscopy in Moderate Sedation: a Randomized Double Blind Controlled Study
- ClinicalTrials.gov ID
- NCT01941888
- Acronym / sponsor ID
- PropTCI/2012 / PropTCI2012
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Sep 2013 (estimated)
- 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.
Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation.
This randomized double blind controlled study compares standard moderate sedation level of sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS (group P).
Detailed description
70 CS and 70 EGD ASA I-II patients were studied. In group S (n=70) we administered fentanyl (1μg/kg) + midazolam (0.04-0.03 mg/kg) for CS and midazolam (0.04-0.03 mg/kg) for EGDS and in group P (n=70) fentanyl 1µg/Kg + propofol TCI 1.2-1.6 μg/ml for CS and propofol TCI 1.2-1.6 μg/ml for EGD. Vital parameters and Observer's Assessment of Alertness and Sedation Scale (OAA/S) were monitored throughout the study. Endoscopist's and patient's satisfactions were measured after procedure and 24-72 h later by visual analog scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Experimental | Drug: Propofol, Device: Target Controlled InfusionPatients in Group Propofol(n=70) were seated with propofol target concentration 1.2-1.6 µg/ml. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control. |
| midazolam | Active comparator | Drug: MidazolamControl Group: patients in Group midazolam (n=70) were sedated with midazolam 0.04 mg/kg if aged< 70 - 0.03 mg/kg if aged> 70. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control. |
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 yrs
- ASA (American Society of Anesthesiologists risk class III-IV)I-II
- patients undergoing to gastroscopy or colonoscopy
Key exclusion criteria (7 listed)
- significant systemic disease (American Society of Anesthesiologists risk class III-IV)
- history of allergic reactions to any of the study drugs
- chronic use of opioid analgesics
- psychiatric disorder
- pregnancy
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 |
|---|---|---|
| Propofol | Drug | propofol |
| Midazolam | Drug | midazolam |
| Target Controlled Infusion | Device | propofol |
Primary outcome
Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation
Time frame: one day
Endoscopist's satisfaction was measured after endoscopic procedures by visual analog scale (VAS 0-100).
Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation
Time frame: one day
Patient's satisfactions were measured after endoscopic procedures and 24-48 hours later by visual analog scale (VAS 0-100).
2 secondary outcomes
Safety (number of partecipants with adverse events) of propofol TCI moderate sedation
Time frame: one day
Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients
Time frame: one day
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 13 Sep 2013.
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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.
Massimo Agostoni, MD study director
San Raffele Hospital
Lorella Fanti, MD principal investigator
San Raffaele Hospital
Marco Gemma, MD principal investigator
San Raffaele Hospital
2 sites 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 Propofol and Target Controlled Infusion, run by Ospedale San Raffaele at 2 sites 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 7 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 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation (time frame: one day). The study lists 2 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 Sep 2013.