Heart Rate Variability Under Propofol and Sevoflurane

NCT ID: NCT03098875

Last Updated: 2017-04-04

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-09-30

Brief Summary

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Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane. Induction and maintenance were standardized, and after the end of surgery, two steady-state recordings were performed at BIS 25 and BIS 55. Bispectral Index and ECG were continuously recorded and cardiac autonomic nervous activity was investigated using spectral analysis of RR Interval variability

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sevoflurane

General anesthesia using sevoflurane as a hypnotic agent, and remifentanil as an analgesic.

Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

General anesthesia using sevoflurane as a hypnotic agent

Remifentanil

Intervention Type DRUG

General anesthesia using remifentanil as an analgesic.

Propofol

General anesthesia using propofol as a hypnotic agent, and remifentanil as an analgesic.

Two steady state periods of 10 minutes each, one with a steady bispectral index at 25 +/- 5, the other with a steady bispectral index at 55 +/- 5. Continuous recording of heart rate during the last minute of each steady-state. Off-line spectral analysis of heart rate variability.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

General anesthesia using propofol as a hypnotic agent

Remifentanil

Intervention Type DRUG

General anesthesia using remifentanil as an analgesic.

Interventions

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Sevoflurane

General anesthesia using sevoflurane as a hypnotic agent

Intervention Type DRUG

Propofol

General anesthesia using propofol as a hypnotic agent

Intervention Type DRUG

Remifentanil

General anesthesia using remifentanil as an analgesic.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA risk classification 1 or 2,
* scheduled for middle ear surgery, or cardiovascular ANS activity.

Exclusion Criteria

* preoperative medications that interfere with the autonomic nervous system
* preoperative medications that interfere with the central nervous system
Minimum Eligible Age

13 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Armand Trousseau

OTHER

Sponsor Role lead

Responsible Party

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Pr Isabelle CONSTANT

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Departement d'anesthesie Hopital Armand Trousseau

Paris, , France

Site Status

Countries

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France

Other Identifiers

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HRV Propofol Sevoflurane

Identifier Type: -

Identifier Source: org_study_id

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