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

This study is currently recruiting participants.

Verified by Copenhagen University Hospital at Herlev, September 2008

Sponsored by:	Copenhagen University Hospital at Herlev
Information provided by:	Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:	NCT00763789

Purpose

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	Intervention
Conscious Sedation Remifentanil Hysteroscopic Surgery Anesthesia Recovery Period Ambulatory Surgery	Other: local anaesthesia and remifentanil sedation Other: total intravenous anaesthesia

MedlinePlus related topics: Anesthesia

Drug Information available for: Remifentanil Remifentanil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department. A Randomized Clinical Trial.

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:

the total time spent in the operating room [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	August 2008
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
1: Experimental Local anaesthesia and remifentanil sedation	Other: local anaesthesia and remifentanil sedation
2 Total intravenous anaesthesia	Other: total intravenous anaesthesia

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763789

Contacts

Contact: Birgitte Majholm, MD	+4544883595	Birmaj01@heh.regionh.dk
Contact: Jørgen H Andersen, M.sc	+4544884782	johvan01@heh.regionh.dk

Locations

Denmark
Copenhagen University Hospital Herlev	Recruiting
Copenhagen, Denmark, DK-2730
Contact: Birgitte Majholm, MD +4544883595 Birmaj01@heh.regionh.dk
Contact: Jørgen H Andersen, M.Sc +4544884782 Johvan01@heh.regionh.dk
Principal Investigator: Birgitte Majholm, MD

Sponsors and Collaborators

Copenhagen University Hospital at Herlev

More Information

Study ID Numbers:	H-D-2008-031
Study First Received:	September 30, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00763789
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Copenhagen University Hospital at Herlev:

conscious sedation
remifentanil
hysteroscopic surgery
anesthesia recovery period

ambulatory surgery
patient satisfaction
length of stay

Study placed in the following topic categories:

Remifentanil

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Pharmacologic Actions
Sensory System Agents
Anesthetics, General

Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009