Influence of a Bolus Administration of Ephedrine and Phenylephrine on the Spinal Oxygen Saturation, Measured With NIRS.

NCT03767296 | Completed Phase 4 DMC

• 1 other identifier: 2016/0644
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the influence of vasoactive medication on the spinal vasculature, we have chosen patients scheduled for arterial dilation of the lower limb as our study population. In these patients the spinal cord perfusion is not compromised. However, most patients will suffer from hypotension during surgery, due to the non-invasive type of surgery and the vasodilating effects of the anesthetics. Therefore, bolus administration of vasoactive medication (ephedrine, phenylephrine) is routinely required in order to increase the blood pressure. The aim of the study is to observe the influence of a bolus administration of ephedrine and phenylephrine on the spinal vasculature, measured by NIRS.

Conditions

Influence of Vasoactive Medication on Spinal Oxygenation

Keywords

spinal oxygenation; NIRS

Outcome Measures

Primary Outcomes (1)

• Spinal oxygen saturation measured by NIRS

  Spinal oxygen saturation measured by NIRS

  from first till 4th MAP decrease > 20 % from baseline

Secondary Outcomes (4)

• Heart rate

  from first till 4th MAP decrease > 20 % from baseline

• Blood pressure

  from first till 4th MAP decrease > 20 % from baseline

• Cerebral oxygenation (NIRS)

  from first till 4th MAP decrease > 20 % from baseline

• Total amount of vasoactive medication used

  from first till 4th MAP decrease > 20 % from baseline

Study Arms (4)

Dose Bolus of E-P-E

EXPERIMENTAL

Ephedrine Hydrochloride 3 MG/ML- Phenylephrine - Ephedrine Hydrochloride 3 MG/ML

Drug: Ephedrine Hydrochloride 3 MG/ML; Drug: Phenylephrine

Dose Bolus P-E-P

EXPERIMENTAL

Phenylephrine- Ephedrine Hydrochloride 3 MG/ML - Phenylephrine

Drug: Ephedrine Hydrochloride 3 MG/ML; Drug: Phenylephrine

Dose Bolus E-E-E

EXPERIMENTAL

Ephedrine Hydrochloride 3 MG/ML- Ephedrine Hydrochloride 3 MG/ML - Ephedrine Hydrochloride 3 MG/ML

Drug: Ephedrine Hydrochloride 3 MG/ML

Dose Bolus P-P-P

EXPERIMENTAL

Phenylephrine-Phenylephrine-Phenylephrine

Drug: Phenylephrine

Interventions

Ephedrine Hydrochloride 3 MG/ML DRUG

Bolus group, according to the randomization. Multiple boluses with incremental doses might be needed, according to the MAP ('effect titration') Incremental doses if needed: Ephedrine (E): 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) A total amount of 140 mg Ephedrine will not be exceeded. Titrated according to the desired effect (= MAP decrease \< 20%)

Dose Bolus E-E-E; Dose Bolus P-E-P; Dose Bolus of E-P-E

Phenylephrine DRUG

Bolus group, according to the randomization. Multiple boluses with incremental doses might be needed, according to the MAP ('effect titration') Incremental doses if needed: Phenylephrine (PE): 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) A total amount of 1500 μg will not be exceeded. Titrated according to the desired effect (= MAP decrease \< 20%)

Dose Bolus P-E-P; Dose Bolus P-P-P; Dose Bolus of E-P-E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18y
• scheduled for dilation of arterial blood vessels of the lower limb

You may not qualify if:

• Age \< 18y
• BMI \> 30
• severe valvular disease
• previous aortic surgery
• paraplegia/ paraparesis
• renal replacement therapy

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

• Vanpeteghem CM, Bruneel BY, Lecoutere IM, De Hert SG, Moerman AT. Ephedrine and phenylephrine induce opposite changes in cerebral and paraspinal tissue oxygen saturation, measured with near-infrared spectroscopy: a randomized controlled trial. J Clin Monit Comput. 2020 Apr;34(2):253-259. doi: 10.1007/s10877-019-00328-6. Epub 2019 Jun 5.

  PMID: 31165350 DERIVED

MeSH Terms

Interventions

Ephedrine; Phenylephrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Ethanolamines

Study Officials

• Caroline Vanpeteghem

  UZ Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: December 6, 2018
• Study Start: February 6, 2017
• Primary Completion: September 9, 2017
• Study Completion: December 4, 2018
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)