Comparing Two Types of Sedation to Gynaecological Patients
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Transcervical Resection of Endometrium; Transcervical Resection of Fibroids; Transcervical Resection of Polyp
Intervention: Remifentanil, propofol and citanest (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s): Igor Filipovski, Principal Investigator, Affiliation: Regionshospital Horsens
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: pain on a NRS-scale from 0 to 10
Secondary outcome: PONVTime Medicin After discharge outcome measures
Detailed description:
Investigate the difference between two types of anesthesia.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
- donĀ“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
Locations and Contacts
Regionshospitalet Horsens, Horsens, Region Midt 8700, Denmark
Additional Information
Starting date: November 2011
Last updated: September 30, 2014
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