Back to results

Comparing Two Types of Sedation to Gynaecological Patients

Primary Purpose

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

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Remifentanil, propofol and citanest

About this trial

This is an interventional supportive care trial for Transcervical Resection of Endometrium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Regionshospitalet Horsens

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

General vs deep sedation

Arm Description

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

Outcomes

Primary Outcome Measures

pain on a NRS-scale from 0 to 10

Measuring postoperative pain in TCRE, TCRF or TCRP patients

Secondary Outcome Measures

PONV

Time

Operating time Recovery time Discharge time

Medicin

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

After discharge outcome measures

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

Full Information

NCT ID

NCT01412632

First Posted

June 15, 2011

Last Updated

September 30, 2014

Sponsor

University of Aarhus

Collaborators

Regionshospitalet Horsens

1. Study Identification

Unique Protocol Identification Number

NCT01412632

Brief Title

Comparing Two Types of Sedation to Gynaecological Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Regionshospitalet Horsens

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

153 (Actual)

8. Arms, Groups, and Interventions

Arm Title

General vs deep sedation

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Remifentanil, propofol and citanest

Intervention Description

iv remifentanil iv propofol im citanest

Primary Outcome Measure Information:

Title

pain on a NRS-scale from 0 to 10

Description

Measuring postoperative pain in TCRE, TCRF or TCRP patients

Time Frame

up to 14 days

Secondary Outcome Measure Information:

Title

PONV

Time Frame

postoperative and 2 weeks after discharge

Title

Time

Description

Operating time Recovery time Discharge time

Time Frame

1 day

Title

Medicin

Description

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

Time Frame

1 day

Title

After discharge outcome measures

Description

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

Time Frame

2 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Igor Filipovski

Organizational Affiliation

Regionshospital Horsens

Official's Role

Principal Investigator

Facility Information:

Facility Name

Regionshospitalet Horsens

City

Horsens

State/Province

Region Midt

ZIP/Postal Code

8700

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Comparing Two Types of Sedation to Gynaecological Patients

We'll reach out to this number within 24 hrs