Colo-rectal CancerADR_NAAPNCT03922074
Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol
A study testing Sedation directed by an endoscopist and Sedation directed by an anesthesiologist in people with Colo-rectal Cancer and Colon Adenoma, run by Serveis de Salut Integrats Baix Empordà.
Trial summary
The Efficacy and safety of Non-anesthesiologist administered propofol (NAAP) for gastrointestinal endoscopy have been widely documented although there is not information which has evaluated the outcomes of colonoscopy it self when the endoscopist has to fulfill the additional task of supervising the sedation. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Colo-rectal Cancer, Colon Adenoma, ADR
- What is being tested?
- Sedation directed by an endoscopist and Sedation directed by an anesthesiologist
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2017to 31 Dec 2019
- 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 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy patients -
Who cannot join
- Patients with familial colorectal cancer history
- -
About this study
Official title: Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol. An Equivalence Trial
The Efficacy and safety of Non-anesthesiologist administered propofol (NAAP) for gastrointestinal endoscopy have been widely documented although there is not information which has evaluated the outcomes of colonoscopy it self when the endoscopist has to fulfill the additional task of supervising the sedation.
Objective: To determine the equivalence of adenoma detection rate (ADR) in colorectal cancer (CRC) screening colonoscopies performed with NAAP and performed with monitored anesthesia care (MAC).
Method: Single blind non-randomized controlled equivalence trial. Patients: Adults between 50 - 69 years old from National CRC screening program (CRCSP). Intervention: The patients are blindly assigned to undergo either colonoscopy with NAAP or MAC according to the arrival of fecal occult blood test, patient's suitability for colonoscopy date and availability of places at endoscopy schedule (with NAAP or MAC).
- Conditions
- Colo-rectal Cancer, Colon Adenoma, ADR
- Being tested
- Sedation directed by an endoscopist, Sedation directed by an anesthesiologist
- Keywords
- ADR with Non-Anesthesiologist administered propofol (NAAP)
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation directed by an endoscopistProcedure or surgery
The nurse begins with fentanyl infusion in bolus: 75 μg (1.5 ml) and initial propofol dose (10mg/ml) in bolus of 0.5 - 2.5 mg/Kg followed by a maintenance dose of 20 - 60ml/h through Target-controlled infusion (TCI) pump. In this way, we get a target level sedation between 1 - 3, according to Observer's Assessment of Alertness/Sedation Scale (OAAS).
The role of the nurse, directed by an endoscopist, it is exclusively the administration of intravenous drugs and the patient monitorship throughout the procedure.
Sedation directed by an anesthesiologistProcedure or surgery
The choice of the drugs and the target level sedation are directed by an anesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| Non-anesthesiologist administered propofol | Experimental | Sedation directed by an endoscopist in which the intravenous drugs are propofol and fentanyl . Target level sedation: moderate - deep. Receives: Procedure: Sedation directed by an endoscopist |
| Monitored anesthesia care | Active comparator | Sedation directed by an anesthesiologist in which the used intravenous drugs and target level sedation are chosen by the anesthesiologist. Receives: Procedure: Sedation directed by an anesthesiologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Percentage of patients aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start2 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serveis de Salut Integrats Baix Empordà
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Alburquerque, Serveis de Salut Integrats Baix Empordà
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922074
- Sponsor's protocol ID
- 42319_TDA_ANE
- Acronym
- ADR_NAAP
- Status last verified
- Sep 2020
- First submitted
- 10 Apr 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol. An Equivalence Trial
- ClinicalTrials.gov ID
- NCT03922074
- Acronym / sponsor ID
- ADR_NAAP / 42319_TDA_ANE
- Conditions
- Colo-rectal Cancer, Colon Adenoma, ADR
- Keywords
- ADR with Non-Anesthesiologist administered propofol (NAAP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Serveis de Salut Integrats Baix EmpordàUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Apr 2019 (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.
The Efficacy and safety of Non-anesthesiologist administered propofol (NAAP) for gastrointestinal endoscopy have been widely documented although there is not information which has evaluated the outcomes of colonoscopy it self when the endoscopist has to fulfill the additional task of supervising the sedation.
Objective: To determine the equivalence of adenoma detection rate (ADR) in colorectal cancer (CRC) screening colonoscopies performed with NAAP and performed with monitored anesthesia care (MAC).
Method: Single blind non-randomized controlled equivalence trial. Patients: Adults between 50 - 69 years old from National CRC screening program (CRCSP). Intervention: The patients are blindly assigned to undergo either colonoscopy with NAAP or MAC according to the arrival of fecal occult blood test, patient's suitability for colonoscopy date and availability of places at endoscopy schedule (with NAAP or MAC).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-anesthesiologist administered propofol | Experimental | Procedure: Sedation directed by an endoscopistSedation directed by an endoscopist in which the intravenous drugs are propofol and fentanyl . Target level sedation: moderate - deep. |
| Monitored anesthesia care | Active comparator | Procedure: Sedation directed by an anesthesiologistSedation directed by an anesthesiologist in which the used intravenous drugs and target level sedation are chosen by the anesthesiologist. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy patients -
Key exclusion criteria (2 listed)
- Patients with familial colorectal cancer history
- -
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 |
|---|---|---|
| Sedation directed by an endoscopistThe nurse begins with fentanyl infusion in bolus: 75 μg (1.5 ml) and initial propofol dose (10mg/ml) in bolus of 0.5 - 2.5 mg/Kg followed by a maintenance dose of 20 - 60ml/h through Target-controlled infusion (TCI) pump. In this way, we get a target level sedation between 1 - 3, according to Observer's Assessment of Alertness/Sedation Scale (OAAS). The role of the nurse, directed by an endoscopist, it is exclusively the administration of intravenous drugs and the patient monitorship throughout the procedure. | Procedure or surgery | Non-anesthesiologist administered propofol |
| Sedation directed by an anesthesiologistThe choice of the drugs and the target level sedation are directed by an anesthesiologist | Procedure or surgery | Monitored anesthesia care |
Primary outcome
Adenoma detection rate
Time frame: 30 days
Percentage of patients aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed
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 16 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation directed by an endoscopist and Sedation directed by an anesthesiologist in people with Colo-rectal Cancer and Colon Adenoma, run by Serveis de Salut Integrats Baix Empordà.
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 2 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Adenoma detection rate (time frame: 30 days). 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 16 Sep 2020.