Comparing Two Types of Sedation to Gynaecological Patients

Transcervical Resection of Endometrium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412632
• Other study ID #: 2010-023843-13
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2011
• Last updated: September 30, 2014
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Investigate the difference between two types of anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Remifentanil, propofol and citanest
iv remifentanil iv propofol im citanest

Locations

Country	Name	City	State
Denmark	Regionshospitalet Horsens	Horsens	Region Midt

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Regionshospitalet Horsens

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain on a NRS-scale from 0 to 10	Measuring postoperative pain in TCRE, TCRF or TCRP patients	up to 14 days
Secondary	PONV		postoperative and 2 weeks after discharge
Secondary	Time	Operating time Recovery time Discharge time	1 day
Secondary	Medicin	The type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin.	1 day
Secondary	After discharge outcome measures	Previous anestetics, pain, PONV, fever, bleeding, discharge time.	2 weeks