Comparing Two Types of Sedation to Gynaecological Patients

University of Aarhus153 enrolled

Overview

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.

Investigate the difference between two types of anesthesia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

153

Conditions

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

Interventions

Remifentanil, propofol and citanestDRUG

iv remifentanil iv propofol im citanest

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Regionshospitalet Horsens

Horsens, Region Midt, Denmark

Outcomes

Primary Outcomes

pain on a NRS-scale from 0 to 10

Measuring postoperative pain in TCRE, TCRF or TCRP patients

Time frame: up to 14 days

Secondary Outcomes

PONV

Time frame: postoperative and 2 weeks after discharge

Time

Operating time Recovery time Discharge time

Time frame: 1 day

Medicin

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

Time frame: 1 day

After discharge outcome measures

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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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