Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea

NCT ID: NCT00452855

Last Updated: 2007-03-29

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

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-05-31

Brief Summary

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The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.

Detailed Description

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Propofol and sevoflurane anaesthesia are used world wide at the anaesthetists discretion.

Propofol is superior to inhalational anaesthetics as anaesthesia for patients at risk of post operative nausea and vomiting (PONV) as PONV is diminished. However, when remifentanil is used as adjuvant to sevoflurane, the total dose of the latter is reduced.

Therefore, we wanted to investigate if sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia with emphasis on nausea, vomiting and total PONV during 24 hours.

In the post anaesthesia care unit (PACU) and in the surgical ward nausea was scored on a visual analogue score. Vomiting was registered.

Conditions

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Nausea Vomiting

Keywords

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Nausea Vomiting Post operative Propofol remifentanil anaesthesia Sevoflurane remifentanil anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Sevoflurane-remifentanil anaesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Females younger than 50 years
* ASA I-II
* Scheduled to gynaecological laparotomies or laparoscopies

Exclusion Criteria

* Medication known to act anti-emetic
* ASA status greater than II
* Malignant hyperthermia
* Allergy to the drugs used.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nielsen, Jens OD, M.D.

UNKNOWN

Sponsor Role collaborator

Central Jutland Regional Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Jens Ole Dich JO Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Viborg Hospital

Viborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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PropSevoRemi

Identifier Type: -

Identifier Source: org_study_id