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Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.

Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department. A Randomized Clinical Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00763789
Enrollment
96
Registered
2008-10-01
Start date
2008-08-31
Completion date
2010-09-30
Last updated
2010-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Surgery, Anesthesia Recovery Period, Conscious Sedation, Hysteroscopic Surgery, Remifentanil

Keywords

conscious sedation, remifentanil, hysteroscopic surgery, anesthesia recovery period, ambulatory surgery, patient satisfaction, length of stay

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.

Interventions

OTHERlocal anaesthesia and remifentanil sedation

Sponsors

Copenhagen University Hospital at Herlev
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
the total time spent in the operating room

Countries

Denmark

Contacts

Primary ContactBirgitte Majholm, MD
Birmaj01@heh.regionh.dk+4544883595
Backup ContactJørgen H Andersen, M.sc
johvan01@heh.regionh.dk+4544884782

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026