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Comparing Two Types of Sedation to Gynaecological Patients

This study is currently recruiting participants.
Verified January 2013 by University of Aarhus
Sponsor:
Collaborator:
Regionshospitalet Horsens
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01412632
First received: June 15, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    Measuring pain postop. in patients who had recieved a TCRE, TCRF or TCRP


Secondary Outcome Measures:
  • PONV [ Time Frame: post operativ and 2 weeks after discharge ] [ Designated as safety issue: No ]
  • Time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Operating time Recovery time Discharge time

  • Medicin [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin.

  • After discharge outcome measures [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Previous anestetics, pain, PONV, fever, bleeding, discharge time.


Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412632

Contacts
Contact: Igor Filipovski 78 42 53 39 Igor.Filipovski@horsens.rm.dk
Contact: Lone D Brix 41679353 loneblund@hotmail.com

Locations
Denmark
Regionshospitalet Horsens Recruiting
Horsens, Region Midt, Denmark, 8700
Contact: Gunnar Madsen     78 42 53 39     Gunnar.madsen@horsens.rm.dk    
Contact: Lone D Brix     41 67 93 53     loneblund@hotmail.com    
Principal Investigator: Gunnar Madsen            
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Horsens
Investigators
Principal Investigator: Igor Filipovski Regionshospital Horsens
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01412632     History of Changes
Other Study ID Numbers: 2010-023843-13
Study First Received: June 15, 2011
Last Updated: January 17, 2013
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Leiomyoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Prilocaine
Propofol
Remifentanil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics

ClinicalTrials.gov processed this record on June 18, 2013