Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Transcervical Resection of Endometrium, Transcervical Resection of Fibroids, Transcervical Resection of Polyp
Female
Transcervical Resection of Endometrium, Transcervical Resection of Fibroids, Transcervical Resection of Polyp
Trial Information
Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens
Investigate the difference between two types of anesthesia.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
pain on a NRS-scale from 0 to 10
Outcome Description:
Measuring pain postop. in patients who had recieved a TCRE, TCRF or TCRP
Outcome Time Frame:
up to 14 days
Safety Issue:
No
Principal Investigator
Igor Filipovski
Investigator Role:
Principal Investigator
Investigator Affiliation:
Regionshospital Horsens
Authority:
Denmark: Danish Medicines Agency
Study ID:
2010-023843-13
NCT ID:
NCT01412632
Start Date:
November 2011
Completion Date:
December 2013
Related Keywords:
- Transcervical Resection of Endometrium
- Transcervical Resection of Fibroids
- Transcervical Resection of Polyp
- Leiomyoma
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