Comparing Two Types of Sedation to Gynaecological Patients

Phase 4

Completed

• Conditions: Transcervical Resection of Endometrium; Transcervical Resection of Fibroids; Transcervical Resection of Polyp
• Interventions: Drug: Remifentanil, propofol and citanest

• Registration Number: NCT01412632
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Investigate the difference between two types of anesthesia.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Study Start: 2011-11
• Primary Completion: 2013-07
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2014-09-30
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

Inclusion Criteria

• >18 years
• females
• are having a TCRE, TCRF or TCRP
• speak and understand Danish
• no mental problems

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General vs deep sedation	Remifentanil, propofol and citanest	General anesthesia: remifentanil and propofol Deep sedation: remifentanil, propofol and citanest

Primary Outcome Measures

Name	Time	Method
pain on a NRS-scale from 0 to 10	up to 14 days	Measuring postoperative pain in TCRE, TCRF or TCRP patients

Secondary Outcome Measures

Name	Time	Method
Medicin	1 day	The type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin.
PONV	postoperative and 2 weeks after discharge
Time	1 day	Operating time Recovery time Discharge time
After discharge outcome measures	2 weeks	Previous anestetics, pain, PONV, fever, bleeding, discharge time.

Trial Locations

Locations (1)

Regionshospitalet Horsens; 🇩🇰 Horsens, Region Midt, Denmark