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

September 30, 2008
January 5, 2010
August 2008
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the total time spent in the operating room [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00763789 on ClinicalTrials.gov Archive Site
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Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.
Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department. A Randomized Clinical Trial.

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Conscious Sedation
  • Remifentanil
  • Hysteroscopic Surgery
  • Anesthesia Recovery Period
  • Ambulatory Surgery
  • Other: local anaesthesia and remifentanil sedation
  • Other: total intravenous anaesthesia
  • Experimental: 1
    Local anaesthesia and remifentanil sedation
    Intervention: Other: local anaesthesia and remifentanil sedation
  • 2
    Total intravenous anaesthesia
    Intervention: Other: total intravenous anaesthesia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
September 2010
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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
Female
18 Years and older
No
Contact: Birgitte Majholm, MD +4544883595 Birmaj01@heh.regionh.dk
Contact: Jørgen H Andersen, M.sc +4544884782 johvan01@heh.regionh.dk
Denmark
 
NCT00763789
H-D-2008-031
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Copenhagen University Hospital at Herlev
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Copenhagen University Hospital at Herlev
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP