Comparing Two Types of Sedation to Gynaecological Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-08-31

Brief Summary

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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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Detailed Description

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Investigate the difference between two types of anesthesia.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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General vs deep sedation

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

Group Type EXPERIMENTAL

Remifentanil, propofol and citanest

Intervention Type DRUG

iv remifentanil iv propofol im citanest

Interventions

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Remifentanil, propofol and citanest

iv remifentanil iv propofol im citanest

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes