Comparing Two Types of Sedation to Gynaecological Patients

This study has been completed.
Sponsor:
Collaborator:
Regionshospitalet Horsens
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01412632
First received: June 15, 2011
Last updated: September 30, 2014
Last verified: August 2013
  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:


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 postoperative pain in TCRE, TCRF or TCRP patients


Secondary Outcome Measures:
  • PONV [ Time Frame: postoperative 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.


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.

  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
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 ClinicalTrials.gov identifier: NCT01412632

Locations
Denmark
Regionshospitalet Horsens
Horsens, Region Midt, Denmark, 8700
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: September 30, 2014
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Propofol
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014