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

Copenhagen University Hospital at Herlev1 site in 1 country96 target enrollmentAugust 2008

ConditionsConscious Sedation Remifentanil Hysteroscopic Surgery Anesthesia Recovery Period Ambulatory Surgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Conscious Sedation
Sponsor: Copenhagen University Hospital at Herlev
Enrollment: 96
Locations: 1
Primary Endpoint: the total time spent in the operating room
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

September 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Copenhagen University Hospital at Herlev

Eligibility 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