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

NCT ID: NCT03767296

Last Updated: 2018-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2018-12-04

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.

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.

Conditions

Influence of Vasoactive Medication on Spinal Oxygenation

Keywords

spinal oxygenation; NIRS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dose Bolus of E-P-E

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

Group Type: EXPERIMENTAL

Ephedrine Hydrochloride 3 MG/ML

Intervention Type: 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%)

Phenylephrine

Intervention Type: 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

Phenylephrine- Ephedrine Hydrochloride 3 MG/ML - Phenylephrine

Group Type: EXPERIMENTAL

Ephedrine Hydrochloride 3 MG/ML

Intervention Type: 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%)

Phenylephrine

Intervention Type: 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 E-E-E

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

Group Type: EXPERIMENTAL

Ephedrine Hydrochloride 3 MG/ML

Intervention Type: 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 P-P-P

Phenylephrine-Phenylephrine-Phenylephrine

Group Type: EXPERIMENTAL

Phenylephrine

Intervention Type: 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%)

Interventions

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%)

Intervention Type: 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%)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Vanpeteghem

Role: PRINCIPAL_INVESTIGATOR

UZ Ghent

Locations

University Hospital Ghent

Ghent, Oost-Vlaanderen, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 31165350 (View on PubMed)

Other Identifiers

2016/0644

Identifier Type: -

Identifier Source: org_study_id