Comparing Two Types of Sedation to Gynaecological Patients

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Transcervical Resection of Polyp; Transcervical Resection of Fibroids; Transcervical Resection of Endometrium

Treatments: Drug: Remifentanil, propofol and citanest

Study type: Interventional

Funder types: Other

Identifiers

NCT01412632

2010-023843-13

Details and patient eligibility

About

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.

Full description

Investigate the difference between two types of anesthesia.

Enrollment: 153 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 1 patient group

General vs deep sedation

Experimental group

Description:

General anesthesia: remifentanil and propofol Deep sedation: remifentanil, propofol and citanest

Treatment:

Drug: Remifentanil, propofol and citanest