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

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.

Study Overview

• Status: Completed
• Conditions: Influence of Vasoactive Medication on Spinal Oxygenation
• Intervention / Treatment: Drug: Ephedrine Hydrochloride 3 MG/ML; Drug: Phenylephrine

Detailed Description

During the preoperative visit, baseline MAP (mean arterial blood pressure) will be defined.

All patients receive standard anesthesia care during the surgical procedure. Before induction of anesthesia, 6 additional sensors (stickers) are applied to the back of the patient (at three levels: 2 at the upper thoracic level, 2 at the lower thoracic level and 2 at the lumbar region). 2 sensors are routinely applied to the forehead to measure the cerebral oxygenation and a BIS sensor is applied to measure the depth of anesthesia. Through an intravenous line anesthetics will be administered. Vasopressor agents will be administered through a second intravenous line. After induction of anesthesia, an endotracheal tube is placed. According to the estimated duration of surgery a bladder catheter is placed.

If - after induction of anesthesia- MAP has decreased more than 20%, a vasopressor agent will be administered in order to increase the blood pressure to normal (preoperative) values. According to the MAP, several bolus administrations and incremental bolus dosages might be needed to reach the target blood pressure range (MAP decrease less than 20%). According to the group to which the patient has been randomized, a bolus of ephedrine and/or phenylephrine will be administered.

The study will be completed when MAP decreases more than 20% from baseline for the 4th time.

A total amount of Ephedrine and Phenylephrine resp. of 140 mg and 1500 μg will not be exceeded.

If the administration of the vasopressor study medication does not achieve the desired result, the patient will receive an appropriate treatment.

The endovascular surgical procedure can start without delay and the duration of surgery will not be prolonged because of the measurements and blood pressure management.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dose Bolus of E-P-E; Ephedrine Hydrochloride 3 MG/ML- Phenylephrine - Ephedrine Hydrochloride 3 MG/ML	Drug: Ephedrine Hydrochloride 3 MG/ML; 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%); Drug: Phenylephrine; 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%)
EXPERIMENTAL: Dose Bolus P-E-P; Phenylephrine- Ephedrine Hydrochloride 3 MG/ML - Phenylephrine	Drug: Ephedrine Hydrochloride 3 MG/ML; 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%); Drug: Phenylephrine; 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%)
EXPERIMENTAL: Dose Bolus E-E-E; Ephedrine Hydrochloride 3 MG/ML- Ephedrine Hydrochloride 3 MG/ML - Ephedrine Hydrochloride 3 MG/ML	Drug: Ephedrine Hydrochloride 3 MG/ML; 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%)
EXPERIMENTAL: Dose Bolus P-P-P; Phenylephrine-Phenylephrine-Phenylephrine	Drug: Phenylephrine; 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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal oxygen saturation measured by NIRS	Spinal oxygen saturation measured by NIRS	from first till 4th MAP decrease > 20 % from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate	from first till 4th MAP decrease > 20 % from baseline
Blood pressure	Blood pressure	from first till 4th MAP decrease > 20 % from baseline
Cerebral oxygenation (NIRS)	Cerebral oxygenation (NIRS)	from first till 4th MAP decrease > 20 % from baseline
Total amount of vasoactive medication used	Total amount of vasoactive medication used	from first till 4th MAP decrease > 20 % from baseline

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Caroline Vanpeteghem, UZ Ghent

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 6, 2017
• Primary Completion (ACTUAL): September 9, 2017
• Study Completion (ACTUAL): December 4, 2018

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (ACTUAL): December 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: NIRS; spinal oxygenation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Ephedrine; Pseudoephedrine; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: 2016/0644

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No