Comparing Two Types of Sedation to Gynaecological Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01412632
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : October 1, 2014
Regionshospitalet Horsens
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Transcervical Resection of Endometrium Transcervical Resection of Fibroids Transcervical Resection of Polyp Drug: Remifentanil, propofol and citanest Phase 4

Detailed Description:
Investigate the difference between two types of anesthesia.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens
Study Start Date : November 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. pain on a NRS-scale from 0 to 10 [ Time Frame: up to 14 days ]
    Measuring postoperative pain in TCRE, TCRF or TCRP patients

Secondary Outcome Measures :
  1. PONV [ Time Frame: postoperative and 2 weeks after discharge ]
  2. Time [ Time Frame: 1 day ]
    Operating time Recovery time Discharge time

  3. Medicin [ Time Frame: 1 day ]
    The type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin.

  4. After discharge outcome measures [ Time Frame: 2 weeks ]
    Previous anestetics, pain, PONV, fever, bleeding, discharge time.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01412632

Regionshospitalet Horsens
Horsens, Region Midt, Denmark, 8700
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Horsens
Principal Investigator: Igor Filipovski Regionshospital Horsens

Responsible Party: University of Aarhus Identifier: NCT01412632     History of Changes
Other Study ID Numbers: 2010-023843-13
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: August 2013

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