Effect of the Duration of Preoperative Fasting on Hypotension Induced by General Anesthesia in the Elderly Person (JEÛNE PREOP)

September 1, 2016 updated by: University Hospital, Brest

The Influence of Duration of Fluid Abstinence on Hypotension During General Anaesthesia Induction for Traumatic Hip Surgery in the Elderly

This study aims to determine if prolonged fasting represents an independent risk factor for hypotension during induction of general anesthesia in the elderly.

Study Overview

Status

Completed

Conditions

Detailed Description

Preoperative fasting aims to reduce the risk of adverse events (eg, inhalation), but may be responsible for dehydration whose consequence is a major hypotension. This problem of hypotension is important because it (MAP <55 mmHg) is directly correlated to the occurrence of pejorative events on the cardiac and renal level and even more so that the duration of the hypotension is long.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized for fracture of the proximal femur requiring surgical treatment

Description

Inclusion Criteria:

  • Risk Score anesthetic ASA I-III
  • Patients ≥ 70 years

  • Suffering from a femoral neck fracture to be treated surgically:

    • either through prosthesis,
    • either by intramedullary nailing (gamma nail)

Exclusion Criteria:

  • Risk Score anesthetic ASA IV
  • Patient on Angiotensin Converting Enzyme (ACE) inhibitors or ARBs (ARA2) within 10 hours before surgery
  • Obesity (BMI> 35) or weight <40kg
  • Need to make a rapid sequence induction
  • Inability to achieve the femoral block (standardization of induction) or patient refusal with respect to the technique.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Follow-up of the variation of the Mean arterial pressure
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Pierre Lafère, Doctor, CHRU de Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEÛNE PREOPERATOIRE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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