The Effect of the ALDH2 Gene Polymorphism on the Propofol Potency for Inducing Loss of Consciousness

The Effect of the ALDH2 Gene Polymorphism on the Propofol Potency for Inducing Loss of Consciousness in Cardiac Patients: a Prospective Observational Study

The aim of this study is to determine whether ALDH2 gene polymorphisms (G/G, G/A A/A) have effect on the potency of propofol.

Study Overview

• Status: Unknown
• Conditions: Propofol
• Intervention / Treatment: Drug: Propofol

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Kefang Guo, MD; Phone Number: +86-13817706936; Email: drguokefang@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

operation rooms for cardiac surgeries in our institution（a major hospital in China)

Description

Inclusion Criteria:

• ASA II

Exclusion Criteria:

• ASA III-IV
• OSAS
• hepatic and renal insufficiency

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
G/G group; Patients who are determined to be G/G genotype.	Drug: Propofol; Patients will be induced to unconsciousness using propofol intravenously.
G/A A/A group; Patients who are determined to be G/A or A/A genotypes.	Drug: Propofol; Patients will be induced to unconsciousness using propofol intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect-site concentration	patient's effect-site concentration when he/she loss consciousness	immediately after patient lose his/her consciousness

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: propofol; ALDH2; potency
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: EAGLES (Alias Study Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No