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

January 5, 2010 updated by: Copenhagen University Hospital at Herlev

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2730
        • Recruiting
        • Copenhagen University Hospital Herlev
        • Contact:
        • Contact:
        • Principal Investigator:
          • Birgitte Majholm, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Local anaesthesia and remifentanil sedation
Other: local anaesthesia and remifentanil sedation
OTHER: 2
Total intravenous anaesthesia
Other: total intravenous anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
the total time spent in the operating room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Study Completion (ANTICIPATED)

September 1, 2010

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (ESTIMATE)

October 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 5, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-D-2008-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Conscious Sedation

Clinical Trials on local anaesthesia and remifentanil sedation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe