This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Comparing Two Types of Sedation to Gynaecological Patients

This study has been completed.
Regionshospitalet Horsens
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: June 15, 2011
Last updated: September 30, 2014
Last verified: August 2013
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: 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT01412632     History of Changes
Other Study ID Numbers: 2010-023843-13
Study First Received: June 15, 2011
Last Updated: September 30, 2014

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 processed this record on July 24, 2017