Local Anaesthesia and Remifentanil Sedation Versus Total Intravenous Anaesthesia for Hysteroscopic Surgery in an Ambulatory Surgery Department.

NCT ID: NCT00763789

Last Updated: 2010-01-06

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to compare a new method: the combination of conscious sedation with remifentanil (a shortlasting opioid drug) and local anaesthesia, with the traditional general anaesthesia for hysteroscopic surgery. The primary outcomes are: the time spent in the operation room, the time to full mobilisation postoperatively and the time to complete recovery postoperatively and the time to discharge. Secondary outcome: patient satisfaction.

Detailed Description

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Conditions

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Conscious Sedation Remifentanil Hysteroscopic Surgery Anesthesia Recovery Period Ambulatory Surgery

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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1

Local anaesthesia and remifentanil sedation

Group Type EXPERIMENTAL

local anaesthesia and remifentanil sedation

Intervention Type OTHER

2

Total intravenous anaesthesia

Group Type OTHER

total intravenous anaesthesia

Intervention Type OTHER

Interventions

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local anaesthesia and remifentanil sedation

Intervention Type OTHER

total intravenous anaesthesia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years,
* ASA classification I-II
* Speaks and writes danish
* Signed informed consent

Exclusion Criteria

* ASA classification III-VI
* Emotional disorder - medically treated within a week before surgery
* Patients in risk of perioperative aspiration - who must be intubated
* BMI \> 35
* Patients who have been using pain medicine within a week before surgery (except PCM and NSAID)
* Patients who have been using sleeping medicine or sedatives within a week before surgery
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Locations

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Copenhagen University Hospital Herlev

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Birgitte Majholm, MD

Role: CONTACT

+4544883595

Jørgen H Andersen, M.sc

Role: CONTACT

+4544884782

Facility Contacts

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Birgitte Majholm, MD

Role: primary

+4544883595

Jørgen H Andersen, M.Sc

Role: backup

+4544884782

Other Identifiers

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H-D-2008-031

Identifier Type: -

Identifier Source: org_study_id

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