Transcervical Resection of EndometriumPhase 4NCT01412632
Comparing Two Types of Sedation to Gynaecological Patients
A Phase 4 study testing Remifentanil, propofol and citanest in people with Transcervical Resection of Endometrium and Transcervical Resection of Fibroids, run by University of Aarhus at 1 site in Denmark.
Trial summary
The primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transcervical Resection of Endometrium, Transcervical Resection of Fibroids, Transcervical Resection of Polyp
- What is being tested?
- Remifentanil, propofol and citanest
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Aug 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years
- females
- are having a TCRE, TCRF or TCRP
- speak and understand Danish
- no mental problems
Who cannot join
- <18 years old
- don´t speak or understand Danish
- mental problems
- Lung problems
- BMI >40
- Big fibroma: >3x3 cm
Show all 9Show fewer
- abuser
- Allergy towards i Propofol, Remifentanil and/or Citanest
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens
The primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.
Read the detailed description
Investigate the difference between two types of anesthesia.
- Conditions
- Transcervical Resection of Endometrium, Transcervical Resection of Fibroids, Transcervical Resection of Polyp
- Being tested
- Remifentanil, propofol and citanest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil, propofol and citanestDrug
iv remifentanil iv propofol im citanest
| Study group | Role | What they receive |
|---|---|---|
| General vs deep sedation | Experimental | General anesthesia: remifentanil and propofol Deep sedation: remifentanil, propofol and citanest Receives: Drug: Remifentanil, propofol and citanest |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain on a NRS-scale from 0 to 10
Measuring postoperative pain in TCRE, TCRF or TCRP patients
Measured: up to 14 days
Secondary outcomes (4)
PONV
Measured: postoperative and 2 weeks after discharge
Time
Operating time Recovery time Discharge time
Measured: 1 day
Medicin
The type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin.
Measured: 1 day
After discharge outcome measures
Previous anestetics, pain, PONV, fever, bleeding, discharge time.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcervical Resection of EndometriumStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Horsens
- Responsible party
- Sponsor
- Investigators
- Igor Filipovski, Principal investigator, Regionshospital Horsens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412632
- Sponsor's protocol ID
- 2010-023843-13
- Status last verified
- Aug 2013
- First submitted
- 15 Jun 2011
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens
- ClinicalTrials.gov ID
- NCT01412632
- Acronym / sponsor ID
- 2010-023843-13
- Conditions
- Transcervical Resection of Endometrium, Transcervical Resection of Fibroids, Transcervical Resection of Polyp
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Horsens
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Aug 2011 (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 primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.
Detailed description
Investigate the difference between two types of anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General vs deep sedation | Experimental | Drug: Remifentanil, propofol and citanestGeneral anesthesia: remifentanil and propofol Deep sedation: remifentanil, propofol and citanest |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years
- females
- are having a TCRE, TCRF or TCRP
- speak and understand Danish
- no mental problems
Key exclusion criteria (9 listed)
- <18 years old
- don´t speak or understand Danish
- mental problems
- Lung problems
- BMI >40
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, propofol and citanestiv remifentanil iv propofol im citanest | Drug | General vs deep sedation |
Primary outcome
pain on a NRS-scale from 0 to 10
Time frame: up to 14 days
Measuring postoperative pain in TCRE, TCRF or TCRP patients
4 secondary outcomes
PONV
Time frame: postoperative and 2 weeks after discharge
Time
Time frame: 1 day
Medicin
Time frame: 1 day
After discharge outcome measures
Time frame: 2 weeks
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 1 Oct 2014.
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.
Igor Filipovski principal investigator
Regionshospital Horsens
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, propofol and citanest in people with Transcervical Resection of Endometrium and Transcervical Resection of Fibroids, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 9 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 1 Oct 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 Denmark. 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?
pain on a NRS-scale from 0 to 10 (time frame: up to 14 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 1 Oct 2014.