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Comparing Two Types of Sedation to Gynaecological Patients

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 9, 2011
Last Update Posted: October 12, 2017
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.
Regionshospitalet Horsens
Information provided by (Responsible Party):
University of Aarhus
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 Intervention Phase
Transcervical Resection of Endometrium Transcervical Resection of Fibroids Transcervical Resection of Polyp Drug: Remifentanil, propofol and citanest Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

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

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

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

Enrollment: 153
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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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
  Contacts and Locations
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 ClinicalTrials.gov 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
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01412632     History of Changes
Other Study ID Numbers: 2010-023843-13
First Submitted: June 15, 2011
First Posted: August 9, 2011
Last Update Posted: October 12, 2017
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