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

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ClinicalTrials.gov Identifier: NCT00763789
Recruitment Status : Unknown
Verified January 2010 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Recruiting
First Posted : October 1, 2008
Last Update Posted : January 6, 2010
Sponsor:
Information provided by:
Copenhagen University Hospital at Herlev

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 1, 2008
Last Update Posted Date January 6, 2010
Study Start Date  ICMJE August 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
the total time spent in the operating room
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.
Official Title  ICMJE Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department. A Randomized Clinical Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Conscious Sedation
  • Remifentanil
  • Hysteroscopic Surgery
  • Anesthesia Recovery Period
  • Ambulatory Surgery
Intervention  ICMJE
  • Other: local anaesthesia and remifentanil sedation
  • Other: total intravenous anaesthesia
Study Arms  ICMJE
  • Experimental: 1
    Local anaesthesia and remifentanil sedation
    Intervention: Other: local anaesthesia and remifentanil sedation
  • 2
    Total intravenous anaesthesia
    Intervention: Other: total intravenous anaesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00763789
Other Study ID Numbers  ICMJE H-D-2008-031
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Copenhagen University Hospital at Herlev
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Copenhagen University Hospital at Herlev
Verification Date January 2010

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