Effect of the Duration of Preoperative Fasting on Hypotension Induced by General Anesthesia in the Elderly Person

Preoperative Fasting and Hypotension Clinical Trial

— JEÛNE PREOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891122
• Other study ID #: JEÛNE PREOPERATOIRE
• Status: Completed
• Phase: N/A
• First received: September 1, 2016
• Last updated: September 1, 2016
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2016
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension
• Preoperative Fasting and Hypotension

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follow-up of the variation of the Mean arterial pressure		8 months	No