PainPhase 4NCT01746641
Remifentanil Versus Propofol for TCI Sedation of Patients Undergoing Gastrointestinal Endoscopic Procedures
A Phase 4 study testing Remifentanil and Propofol in people with Pain, run by Fundación Universitaria de Ciencias de la Salud at 1 site in Colombia.
Trial summary
The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Remifentanil and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2010to Jun 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing elective higher, lower or mixed gastrointestinal endoscopy at Hospital de San Jose, Bogota, between January and December 2010.
- Be between 18 and 70 years old.
- American Society of Anesthesiology Physical Status classification between 1 and 3.
- Provide written informed consent.
Who cannot join
- Patients with difficult airway indicators.
- Pregnant women.
- Patients with chronic pain.
- Chronic opioid or benzodiazepine users (>3 months).
- Allergy history to remifentanil or propofol or eggs.
- Psychoactive drug users.
- Smokers (> 5 cigarettes per day in the previous 3 months).
- Body mass index > 30.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Universitaria de Ciencias de la Salud
Bogotá, Bogota D.C., 11001000
About this study
Official title: Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial
The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures.
Read the detailed description
The administration of sedation with target controlled infusion (TCI) systems could offer a safe alternative for the management of discomfort of patients undergoing endoscopic gastrointestinal procedures. However, what medication from those available for TCI would be the most appropriate is not known.
Sixty-nine patients requiring a gastrointestinal endoscopic procedure were randomly assigned to receive a TCI effect site (e) of remifentanil (n=30) or propofol (n=39). The primary outcome was patient satisfaction. Secondary outcomes included gastroenterologist satisfaction, the proportion of adverse events between the two groups were compared (occurrence of cardiac arrhythmias, mild respiratory depression, major respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, and lack of amnesia), and the level of consciousness.
- Conditions
- Pain
- Being tested
- Remifentanil, Propofol
- Keywords
- Remifentanil, Propofol, Sedation, Endoscopy, Gastroenterology, Target controlled infusion effect site
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Active comparator | Remifentanil target controlled infusion effect site with Minto's pharmacokinetic model.
Start dose: 1 ng/mL. Titration: 0.5 ng/mL according to clinical criteria. Receives: Drug: Remifentanil |
| Propofol | Active comparator | Propofol target controlled infusion effect site with Marsh's pharmacokinetic model.
Start dose: 1 mcg/mL. Titration: 0.5 mcg/mL according to clinical criteria. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Measured with a analog scale from 1 to 4:
- Excellent.
- Good.
- Regular.
- No.
Measured: At the end of the procedure, expected average of 30 minutes
Secondary outcomes (2)
Gastroenterologist satisfaction
Measured with a analog scale from 1 to 4:
- Excellent.
- Good.
- Regular.
- No.
Measured: At the end of the procedure, expected average of 30 minutes
Adverse events
Occurrence of cardiac arrythmias, mild respiratory depression, severe respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, absence of amnesia.
Measured: At the end of the procedure, expected average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Occurrence of severe respiratory depression in the remifentanil group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria de Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de San Jose
- Responsible party
- Sponsor
- Investigators
- Luis A Muñoz, MD, Study director, Fundacion Universitaria de Ciencias de la SaludLuis E Reyes, MD, Principal investigator, Fundacion Universitaria de Ciencias de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746641
- Sponsor's protocol ID
- Acta No. 197
- Status last verified
- Dec 2012
- First submitted
- 30 Jul 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01746641
- Acronym / sponsor ID
- Acta No. 197
- Conditions
- Pain
- Keywords
- Remifentanil, Propofol, Sedation, Endoscopy, Gastroenterology, Target controlled infusion effect site
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Occurrence of severe respiratory depression in the remifentanil group.
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Fundación Universitaria de Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Hospital de San Jose
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Dec 2012 (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.
The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures.
Detailed description
The administration of sedation with target controlled infusion (TCI) systems could offer a safe alternative for the management of discomfort of patients undergoing endoscopic gastrointestinal procedures. However, what medication from those available for TCI would be the most appropriate is not known.
Sixty-nine patients requiring a gastrointestinal endoscopic procedure were randomly assigned to receive a TCI effect site (e) of remifentanil (n=30) or propofol (n=39). The primary outcome was patient satisfaction. Secondary outcomes included gastroenterologist satisfaction, the proportion of adverse events between the two groups were compared (occurrence of cardiac arrhythmias, mild respiratory depression, major respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, and lack of amnesia), and the level of consciousness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Active comparator | Drug: RemifentanilRemifentanil target controlled infusion effect site with Minto's pharmacokinetic model. Start dose: 1 ng/mL. Titration: 0.5 ng/mL according to clinical criteria. |
| Propofol | Active comparator | Drug: PropofolPropofol target controlled infusion effect site with Marsh's pharmacokinetic model. Start dose: 1 mcg/mL. Titration: 0.5 mcg/mL according to clinical criteria. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing elective higher, lower or mixed gastrointestinal endoscopy at Hospital de San Jose, Bogota, between January and December 2010.
- Be between 18 and 70 years old.
- American Society of Anesthesiology Physical Status classification between 1 and 3.
- Provide written informed consent.
Key exclusion criteria (8 listed)
- Patients with difficult airway indicators.
- Pregnant women.
- Patients with chronic pain.
- Chronic opioid or benzodiazepine users (>3 months).
- Allergy history to remifentanil or propofol or eggs.
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 |
|---|---|---|
| Remifentanil | Drug | Remifentanil |
| Propofol | Drug | Propofol |
Primary outcome
Patient satisfaction
Time frame: At the end of the procedure, expected average of 30 minutes
Measured with a analog scale from 1 to 4: 1. Excellent. 2. Good. 3. Regular. 4. No.
2 secondary outcomes
Gastroenterologist satisfaction
Time frame: At the end of the procedure, expected average of 30 minutes
Adverse events
Time frame: At the end of the procedure, expected average of 30 minutes
Results and safety
The study was stopped early (reason given: Occurrence of severe respiratory depression in the remifentanil group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
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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.
Luis A Muñoz, MD study director
Fundacion Universitaria de Ciencias de la Salud
Luis E Reyes, MD principal investigator
Fundacion Universitaria de Ciencias de la Salud
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 Remifentanil and Propofol in people with Pain, run by Fundación Universitaria de Ciencias de la Salud at 1 site in Colombia.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Dec 2012. 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 Colombia. 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 was stopped early (reason given: Occurrence of severe respiratory depression in the remifentanil group.). Results are not available in the source record.
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?
Patient satisfaction (time frame: At the end of the procedure, expected average of 30 minutes). 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 11 Dec 2012.