Clinical trial NCT03642301: Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal Hyperbaric Prilocaine.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: Hemoglobin adducts from o-toluidine in blood
Urinary o-toluidine
Intrathecal anesthesia
Hyperbaric prilocaine
Ambulatory surgery
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: Ruhr University of Bochum
name: Hôpital de Braine-l'Alleud
First posted: 2018-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient scheduled for an 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin adducts from o-toluidine in blood
timeFrame: Time 0 (before surgery)
measure: Hemoglobin adducts from o-toluidine in blood
timeFrame: Time 24 hours after intrathecal prilocaine injection
measure: Urinary o-toluidine
timeFrame: Time 0 (before surgery)
measure: Urinary o-toluidine
timeFrame: Time 6 hours after intrathecal prilocaine injection
measure: Urinary o-toluidine
timeFrame: Time 12 hours after intrathecal prilocaine injection
measure: Urinary o-toluidine
timeFrame: Time 24 hours after intrathecal prilocaine injection
Secondary outcomes:
Other outcomes:
Locations:
city: Braine-l'Alleud
country: Belgium
facility: Braine-l'Alleud Hospital
Study officials:
affiliation: Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
name: Emmanuel Guntz, MD
role: STUDY_DIRECTOR
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Panayota Kapessidou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaber K, Harreus UA, Matthias C, Kleinsasser NH, Richter E. Hemoglobin adducts of the human bladder carcinogen o-toluidine after treatment with the local anesthetic prilocaine. Toxicology. 2007 Jan 5;229(1-2):157-64. doi: 10.1016/j.tox.2006.10.012. Epub 2006 Oct 29.
citation: Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.
citation: Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7.
citation: Gebhardt V, Herold A, Weiss C, Samakas A, Schmittner MD. Dosage finding for low-dose spinal anaesthesia using hyperbaric prilocaine in patients undergoing perianal outpatient surgery. Acta Anaesthesiol Scand. 2013 Feb;57(2):249-56. doi: 10.1111/aas.12031. Epub 2012 Nov 30.
citation: Bohm F, Schmid D, Denzinger S, Wieland WF, Richter E. DNA adducts of ortho-toluidine in human bladder. Biomarkers. 2011 Mar;16(2):120-8. doi: 10.3109/1354750X.2010.534556. Epub 2010 Nov 30.
citation: Guntz E, Carini A, Koslitz S, Bruning T, Kapessidou P, Weiss T. Quantification of systemic o-toluidine after intrathecal administration of hyperbaric prilocaine in humans: a prospective cohort study. Arch Toxicol. 2021 Mar;95(3):925-934. doi: 10.1007/s00204-021-02973-w. Epub 2021 Jan 21.