NCT03762538

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 3, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

November 27, 2018

Last Update Submit

November 30, 2018

Conditions

Keywords

propofolALDH2potency

Outcome Measures

Primary Outcomes (1)

  • Effect-site concentration

    patient's effect-site concentration when he/she loss consciousness

    immediately after patient lose his/her consciousness

Study Arms (2)

G/G group

Patients who are determined to be G/G genotype.

Drug: Propofol

G/A A/A group

Patients who are determined to be G/A or A/A genotypes.

Drug: Propofol

Interventions

Patients will be induced to unconsciousness using propofol intravenously.

G/A A/A groupG/G group

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ASA II

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

December 3, 2018

Study Start

February 1, 2019

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

December 3, 2018

Record last verified: 2018-01