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OpenTrials
Completed

NCT Number: NCT01412632

Comparing Two Types of Sedation to Gynaecological Patients

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.

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Key information

Conditions

Transcervical Resection of Endometrium Transcervical Resection of Fibroids Transcervical Resection of Polyp

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Regionshospitalet Horsens

Horsens, Region Midt, 8700, Denmark

About this study

Investigate the difference between two types of anesthesia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil, propofol and citanest

Drug

iv remifentanil iv propofol im citanest

Primary outcomes

  1. pain on a NRS-scale from 0 to 10

    Time frame: up to 14 days

    Measuring postoperative pain in TCRE, TCRF or TCRP patients

Secondary outcomes

  1. PONV

    Time frame: postoperative and 2 weeks after discharge

  2. Time

    Time frame: 1 day

    Operating time Recovery time Discharge time

  3. Medicin

    Time frame: 1 day

    The type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin.

  4. After discharge outcome measures

    Time frame: 2 weeks

    Previous anestetics, pain, PONV, fever, bleeding, discharge time.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Regionshospitalet Horsens

Registry information

Official study title

Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2011
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.