Comparing Two Types of Sedation to Gynaecological Patients

September 30, 2014 updated by: University of Aarhus

Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens

The primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigate the difference between two types of anesthesia.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 4

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
    • Region Midt
      • Horsens, Region Midt, Denmark, 8700
        • Regionshospitalet Horsens

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:

  • >18 years
  • females
  • are having a TCRE, TCRF or TCRP
  • speak and understand Danish
  • no mental problems

Exclusion Criteria:

  • <18 years old
  • don´t speak or understand Danish
  • mental problems
  • Lung problems
  • BMI >40
  • Big fibroma: >3x3 cm
  • abuser
  • Allergy towards i Propofol, Remifentanil and/or Citanest
  • pregnant

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: General vs deep sedation
General anesthesia: remifentanil and propofol Deep sedation: remifentanil, propofol and citanest
Drug: Remifentanil, propofol and citanest
iv remifentanil iv propofol im citanest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain on a NRS-scale from 0 to 10
Time Frame: up to 14 days
Measuring postoperative pain in TCRE, TCRF or TCRP patients
up to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PONV
Time Frame: postoperative and 2 weeks after discharge
postoperative and 2 weeks after discharge
Time
Time Frame: 1 day
Operating time Recovery time Discharge time
1 day
Medicin
Time Frame: 1 day
The type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin.
1 day
After discharge outcome measures
Time Frame: 2 weeks
Previous anestetics, pain, PONV, fever, bleeding, discharge time.
2 weeks

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Regionshospitalet Horsens

Investigators

  • Principal Investigator: Igor Filipovski, Regionshospital Horsens

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

November 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 15, 2011

First Submitted That Met QC Criteria

August 8, 2011

First Posted (Estimate)

August 9, 2011

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 30, 2014

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-023843-13

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.

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