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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Copenhagen University Hospital at Herlev.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00763789
First received: September 30, 2008
Last updated: January 5, 2010
Last verified: January 2010
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

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: September 2010
Arms Assigned Interventions
Experimental: 1
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

No publications provided

ClinicalTrials.gov Identifier: NCT00763789     History of Changes
Other Study ID Numbers: H-D-2008-031
Study First Received: September 30, 2008
Last Updated: January 5, 2010
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

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Intravenous
Anesthetics, General
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 22, 2013