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

• ClinicalTrials.gov Identifier: NCT03767296
• Recruitment Status: Completed
• First Posted: December 6, 2018
• Last Update Posted: December 7, 2018
• Sponsor: University Hospital, Ghent
• Information provided by (Responsible Party): University Hospital, Ghent

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influence of Vasoactive Medication on Spinal Oxygenation	Drug: Ephedrine Hydrochloride 3 MG/ML; Drug: Phenylephrine	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Influence of a Bolus Administration of Ephedrine and Phenylephrine on the Spinal Oxygen Saturation, Measured With NIRS.
• Actual Study Start Date: February 6, 2017
• Actual Primary Completion Date: September 9, 2017
• Actual Study Completion Date: December 4, 2018

Arms and Interventions

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%)

Outcome Measures

Primary Outcome Measures :

1. Spinal oxygen saturation measured by NIRS [ Time Frame: from first till 4th MAP decrease > 20 % from baseline ]
   Spinal oxygen saturation measured by NIRS

Secondary Outcome Measures :

1. Heart rate [ Time Frame: from first till 4th MAP decrease > 20 % from baseline ]
   Heart rate
2. Blood pressure [ Time Frame: from first till 4th MAP decrease > 20 % from baseline ]
   Blood pressure
3. Cerebral oxygenation (NIRS) [ Time Frame: from first till 4th MAP decrease > 20 % from baseline ]
   Cerebral oxygenation (NIRS)
4. Total amount of vasoactive medication used [ Time Frame: from first till 4th MAP decrease > 20 % from baseline ]
   Total amount of vasoactive medication used

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Belgium

University Hospital Ghent

Gent, Oost-Vlaanderen, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

• Principal Investigator: Caroline Vanpeteghem; UZ Ghent

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT03767296
• Other Study ID Numbers: 2016/0644
• First Posted: December 6, 2018
• Last Update Posted: December 7, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by University Hospital, Ghent:

spinal oxygenation; NIRS

Additional relevant MeSH terms:

Phenylephrine; Oxymetazoline; Ephedrine; Pseudoephedrine; Cardiotonic Agents; Mydriatics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Respiratory System Agents; Adrenergic alpha-1 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents; Central Nervous System Stimulants; Bronchodilator Agents; Anti-Asthmatic Agents