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

Sponsor

Copenhagen University Hospital at Herlev (Other)

Overall Status

Unknown status

CT.gov ID

NCT00763789

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Conscious Sedation Remifentanil Hysteroscopic Surgery Anesthesia Recovery Period Ambulatory Surgery	Other: local anaesthesia and remifentanil sedation Other: total intravenous anaesthesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Aug 1, 2008

Anticipated Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Local anaesthesia and remifentanil sedation	Other: local anaesthesia and remifentanil sedation
Other: 2 Total intravenous anaesthesia	Other: total intravenous anaesthesia

Arm

Intervention/Treatment

Experimental: 1

Local anaesthesia and remifentanil sedation

Other: local anaesthesia and remifentanil sedation

Other: 2

Total intravenous anaesthesia

Other: total intravenous anaesthesia

Outcome Measures

Primary Outcome Measures

the total time spent in the operating room []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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