Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal Hyperbaric Prilocaine.

NCT03642301 | Completed

• 1 other identifier: B076201836443
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Hemoglobin adducts from o-toluidine in blood

  Hemoglobin adducts from o-toluidine in blood is measured before surgery (at admission)

  Time 0 (before surgery)

• Hemoglobin adducts from o-toluidine in blood

  Hemoglobin adducts from o-toluidine in blood is measured at 24 hours after intrathecal prilocaine injection

  Time 24 hours after intrathecal prilocaine injection

• Urinary o-toluidine

  Urinary o-toluidine is measured before surgery (at admission)

  Time 0 (before surgery)

• Urinary o-toluidine

  Urinary o-toluidine is measured at 6 hours after intrathecal prilocaine injection

  Time 6 hours after intrathecal prilocaine injection

• Urinary o-toluidine

  Urinary o-toluidine is measured at 12 hours after intrathecal prilocaine injection

  Time 12 hours after intrathecal prilocaine injection

• Urinary o-toluidine

  Urinary o-toluidine is measured at 24 hours after intrathecal prilocaine injection

  Time 24 hours after intrathecal prilocaine injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient scheduled for an ambulatory surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead
• Ruhr University of Bochum: collaborator
• Hôpital de Braine-l'Alleud: collaborator

Study Sites (1)

Braine-l'Alleud Hospital

Braine-l'Alleud, 1420, Belgium

Location

Related Publications (6)

• 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.

  PMID: 17129655 BACKGROUND

• 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.

  PMID: 20529983 BACKGROUND

• 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.

  PMID: 24906303 BACKGROUND

• 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.

  PMID: 23199005 BACKGROUND

• 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.

  PMID: 21117897 BACKGROUND

• 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.

  PMID: 33475793 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (2 samples) and Urine (4 samples)

Study Officials

• Emmanuel Guntz, MD

  Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital

  STUDY DIRECTOR

• Panayota Kapessidou, MD,PhD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 22, 2018
• Study Start: January 10, 2019
• Primary Completion: March 27, 2019
• Study Completion: March 27, 2019
• Last Updated: May 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)