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

Not Applicable

• Conditions: Remifentanil; Ambulatory Surgery; Anesthesia Recovery Period; Conscious Sedation; Hysteroscopic Surgery
• Interventions: Other: total intravenous anaesthesia; Other: local anaesthesia and remifentanil sedation

• Registration Number: NCT00763789
• Lead Sponsor: Copenhagen University Hospital at Herlev

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-05
• Last Update Posted: 2010-01-06
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	total intravenous anaesthesia	Total intravenous anaesthesia
1	local anaesthesia and remifentanil sedation	Local anaesthesia and remifentanil sedation

Primary Outcome Measures

Name	Time	Method
the total time spent in the operating room

Trial Locations

Locations (1)

Copenhagen University Hospital Herlev; 🇩🇰 Copenhagen, Denmark