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NCT00763789 Clinical Trial

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

Conscious Sedation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00763789
Other study ID # H-D-2008-031
Secondary ID
Status Recruiting
Phase N/A
First received September 30, 2008
Last updated January 5, 2010
Start date August 2008
Est. completion date September 2010

Study information
Verified date January 2010
Source Copenhagen University Hospital at Herlev
Contact Birgitte Majholm, MD
Phone +4544883595
Email Birmaj01@heh.regionh.dk
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 96
Est. completion date September 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• local anaesthesia and remifentanil sedation

• total intravenous anaesthesia

Locations
Country Name City State
Denmark Copenhagen University Hospital Herlev Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary the total time spent in the operating room No
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