Conscious SedationNCT00763789
Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.
A study testing local anaesthesia and remifentanil sedation and total intravenous anaesthesia in people with Conscious Sedation and Remifentanil, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
The purpose of this study is to compare a new method: the combination of conscious sedation with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional general anaesthesia for hysteroscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Conscious Sedation, Remifentanil, Hysteroscopic Surgery
- What is being tested?
- local anaesthesia and remifentanil sedation and total intravenous anaesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2008to Sep 2010
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years,
- ASA classification I-II
- Speaks and writes danish
- Signed informed consent
Who cannot join
- ASA classification III-VI
- Emotional disorder - medically treated within a week before surgery
- Patients in risk of perioperative aspiration - who must be intubated
- BMI > 35
- Patients who have been using pain medicine within a week before surgery (except PCM and NSAID)
- Patients who have been using sleeping medicine or sedatives within a week before surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Herlev
Copenhagen, DK-2730
Birgitte Majholm, MD, +4544883595, Birmaj01@heh.regionh.dk
Jørgen H Andersen, M.Sc, +4544884782, Johvan01@heh.regionh.dk
About this study
Official title: Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department. A Randomized Clinical Trial.
The purpose of this study is to compare a new method: the combination of conscious sedation with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional general anaesthesia for hysteroscopic surgery. The primary outcomes are: the time spent in the operation room, the time to full mobilisation postoperatively and the time to complete recovery postoperatively and the time to discharge. Secondary outcome: patient satisfaction.
- Conditions
- Conscious Sedation, Remifentanil, Hysteroscopic Surgery, Anesthesia Recovery Period, Ambulatory Surgery
- Being tested
- local anaesthesia and remifentanil sedation, total intravenous anaesthesia
- Keywords
- conscious sedation, remifentanil, hysteroscopic surgery, anesthesia recovery period, ambulatory surgery, patient satisfaction, length of stay
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anaesthesia and remifentanil sedationOther
total intravenous anaesthesiaOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Local anaesthesia and remifentanil sedation Receives: Other: local anaesthesia and remifentanil sedation |
| 2 | Other | Total intravenous anaesthesia Receives: Other: total intravenous anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total time spent in the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startAug 2008
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763789
- Sponsor's protocol ID
- H-D-2008-031
- Status last verified
- Jan 2010
- First submitted
- 30 Sep 2008
- Last updated
- 6 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT00763789
- Acronym / sponsor ID
- H-D-2008-031
- Conditions
- Conscious Sedation, Remifentanil, Hysteroscopic Surgery, Anesthesia Recovery Period, Ambulatory Surgery
- Keywords
- conscious sedation, remifentanil, hysteroscopic surgery, anesthesia recovery period, ambulatory surgery, patient satisfaction, length of stay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Aug 2008
- Study completion
- Sep 2010 (estimated)
- First posted
- 1 Oct 2008 (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 is to compare a new method: the combination of conscious sedation with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional general anaesthesia for hysteroscopic surgery. The primary outcomes are: the time spent in the operation room, the time to full mobilisation postoperatively and the time to complete recovery postoperatively and the time to discharge. Secondary outcome: patient satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: local anaesthesia and remifentanil sedationLocal anaesthesia and remifentanil sedation |
| 2 | Other | Other: total intravenous anaesthesiaTotal intravenous anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years,
- ASA classification I-II
- Speaks and writes danish
- Signed informed consent
Key exclusion criteria (6 listed)
- ASA classification III-VI
- Emotional disorder - medically treated within a week before surgery
- Patients in risk of perioperative aspiration - who must be intubated
- BMI > 35
- Patients who have been using pain medicine within a week before surgery (except PCM and NSAID)
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 |
|---|---|---|
| local anaesthesia and remifentanil sedation | Other | 1 |
| total intravenous anaesthesia | Other | 2 |
Primary outcome
the total time spent in the operating room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anaesthesia and remifentanil sedation and total intravenous anaesthesia in people with Conscious Sedation and Remifentanil, run by Copenhagen University Hospital at Herlev 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 4 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: status not confirmed, as of the sponsor's last update on 6 Jan 2010. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgitte Majholm, MD (+4544883595, Birmaj01@heh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total time spent in the operating room. 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 6 Jan 2010.