Measured Hypocretin Levels and Recovery After Hip Surgery

Osteoarthritis, Hip Clinical Trial

Official title:

Preoperative Cerebrospinal Fluid (CSF) Levels of Hypocretin and Recovery After Hip Surgery With Combined Spinal and General Anesthesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01009710
• Other study ID #: SU-07162009-3301
• Secondary ID: 16339
• Status: Active, not recruiting
• Phase: N/A
• First received: November 5, 2009
• Last updated: January 14, 2017
• Start date: July 2009
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A specific group of neurons in the brain produces hypocretin, a peptide which has been established as an important regulator of sleep and wakefulness. Activation of these neurons (increased hypocretin) stabilizes wakefulness; impairing or blocking these neurons (decreased hypocretin) promotes sleep. Evidence suggests that these neurons may be involved in the hypnotic properties of several anesthetics, and play a role in the induction and emergence from anesthesia. In humans there is a considerable inter-individual variability in hypocretin levels. This study aims to investigate how hypocretin levels affect the anesthetic care and recovery of patients undergoing elective hip surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:- Adult (18 years of age or older)

• Male or female

• Scheduled for elective total hip arthroplasty at the Stanford Orthopedic Clinic.

• Comprehend spoken and written English

Exclusion Criteria:- ASA physical status > III (patients with severe systemic disease)

• Diagnosed psychiatric disease (except mild depression)

• Any diagnoses CNS disease or dementia

• History of stroke

• History of untreated thyroid disease

• Difficulty in airway management (ventilation and/or intubation)

• Body Mass Index (BMI) > 35 kg/m2

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anesthetic Recovery Times	recovery from anesthesia will be measured by short-term outcomes like time to tracheal extubation and response to verbal commands, as well as by psycho-vigilance testing up to 72 hours postoperatively	0-72 hours after surgery
Secondary	sensitivity to sevoflurane during inhalation induction to anesthesia, determined by bispectral index of the EEG	pharmacodynamic analysis of bispectral index of the EEG response to sevoflurane	during anesthetic induction
Secondary	pain and sleepiness	assessment of pain and sleepiness using the numerical rating scale (0-10) during the 72 hours postoperatively	from 0-72 hours after surgery