Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.
Information source: Copenhagen University Hospital at Herlev
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Conscious Sedation; Remifentanil; Hysteroscopic Surgery; Anesthesia Recovery Period; Ambulatory Surgery
Intervention: local anaesthesia and remifentanil sedation (Other); total intravenous anaesthesia (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Copenhagen University Hospital at Herlev Overall contact:
Birgitte Majholm, MD, Phone: +4544883595, Email: Birmaj01@heh.regionh.dk
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.
Clinical Details
Official title: Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department. A Randomized Clinical Trial.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: the total time spent in the operating room
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Age > 18 years,
- ASA classification I-II
- Speaks and writes danish
- Signed informed consent
Exclusion Criteria:
- 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
Locations and Contacts
Birgitte Majholm, MD, Phone: +4544883595, Email: Birmaj01@heh.regionh.dk
Copenhagen University Hospital Herlev, Copenhagen DK-2730, Denmark; Recruiting
Birgitte Majholm, MD, Phone: +4544883595, Email: Birmaj01@heh.regionh.dk
Jørgen H Andersen, M.Sc, Phone: +4544884782, Email: Johvan01@heh.regionh.dk
Birgitte Majholm, MD, Principal Investigator
Additional Information
Starting date: August 2008
Last updated: January 5, 2010
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