Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.
1 other identifier
interventional
96
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJanuary 6, 2010
January 1, 2010
September 30, 2008
January 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the total time spent in the operating room
Study Arms (2)
1
EXPERIMENTALLocal anaesthesia and remifentanil sedation
2
OTHERTotal intravenous anaesthesia
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18 years,
- ASA classification I-II
- Speaks and writes danish
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Copenhagen University Hospital Herlev
Copenhagen, DK-2730, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 30, 2008
First Posted
October 1, 2008
Study Start
August 1, 2008
Study Completion
September 1, 2010
Last Updated
January 6, 2010
Record last verified: 2010-01