Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal Hyperbaric Prilocaine.

Dosing of Carcinogenic Complexes Such as Urinary O-toluidine and Hemoglobin Adducts From O-toluidine in Blood After Intrathecal Administration of 50 mg Hyperbaric Prilocaine

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03642301

Enrollment

Registered

2018-08-22

Start date

2019-01-10

Completion date

2019-03-27

Last updated

2019-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Hemoglobin adducts from o-toluidine in blood, Urinary o-toluidine, Intrathecal anesthesia, Hyperbaric prilocaine, Ambulatory surgery

Brief summary

The prilocaine is a very common local anesthetic that has the disadvantage of being metabolized to o-toluidine, a human carcinogen. Hyperbaric 2% prilocaine (HP), recently developped, is increasingly used for spinal anesthesia in ambulatory surgery. But the formation of carcinogenic metabolites induced by the hyperbaric prilocaine is not yet known. The aim of this study is to investigate whether the intrathecal administration of 50 mg hyperbaric prilocaine induces also the formation of carcinogenic complexes such as urinary o-toluidine and hemoglobin adducts from o-toluidine in blood.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age : \> 18 years and \< 80years * American Society of Anesthesiology (ASA) score : I-II * Height between 160cm and 180cm

Exclusion criteria

* Cardiac Disease (Aortic stenosis, heart failure...) * coagulation disorder (International Normalized Ratio (INR) \> 1.3; platelets \<80 000/mm³) * Allergic to local anesthetics * Smoker

Design outcomes

Primary

Measure	Time frame	Description
Hemoglobin adducts from o-toluidine in blood	Time 0 (before surgery)	Hemoglobin adducts from o-toluidine in blood is measured before surgery (at admission)
Urinary o-toluidine	Time 0 (before surgery)	Urinary o-toluidine is measured before surgery (at admission)

Countries

Belgium

Outcome results