Heart Rate Variability Under Propofol and Sevoflurane

NCT03098875 | Completed

• 1 other identifier: HRV Propofol Sevoflurane
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (2)

• Spectral analysis of heart rate variability with a bispectral index of 25

  Fast Fourier Transform applied to heart rate signal recording

  During surgical procedure

• Spectral analysis of heart rate variability with a bispectral index of 55

  Fast Fourier Transform applied to heart rate signal recording

  During surgical procedure

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

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.

Drug: Sevoflurane; Drug: Remifentanil

Propofol

ACTIVE COMPARATOR

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.

Drug: Propofol; Drug: Remifentanil

Interventions

Sevoflurane DRUG

General anesthesia using sevoflurane as a hypnotic agent

Sevoflurane

Propofol DRUG

General anesthesia using propofol as a hypnotic agent

Propofol

Remifentanil DRUG

General anesthesia using remifentanil as an analgesic.

Propofol; Sevoflurane

Eligibility Criteria

• Age: 13 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• preoperative medications that interfere with the autonomic nervous system
• preoperative medications that interfere with the central nervous system

Sponsors & Collaborators

• Hôpital Armand Trousseau: lead

Study Sites (1)

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Location

MeSH Terms

Interventions

Sevoflurane; Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: April 4, 2017
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2010
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)