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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:

PONV

Time

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

Page last updated: August 23, 2015

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