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

Influence of Vasoactive Medication on Spinal Oxygenation Clinical Trial

— NIRS BOLUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767296
• Other study ID #: 2016/0644
• Status: Completed
• Phase: Phase 4
• Start date: February 6, 2017
• Est. completion date: December 4, 2018

Study information

• Verified date: December 2018
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 4, 2018
• Est. primary completion date: September 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influence of Vasoactive Medication on Spinal Oxygenation

Intervention

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%)
• 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%)

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal oxygen saturation measured by NIRS	Spinal oxygen saturation measured by NIRS	from first till 4th MAP decrease > 20 % from baseline
Secondary	Heart rate	Heart rate	from first till 4th MAP decrease > 20 % from baseline
Secondary	Blood pressure	Blood pressure	from first till 4th MAP decrease > 20 % from baseline
Secondary	Cerebral oxygenation (NIRS)	Cerebral oxygenation (NIRS)	from first till 4th MAP decrease > 20 % from baseline
Secondary	Total amount of vasoactive medication used	Total amount of vasoactive medication used	from first till 4th MAP decrease > 20 % from baseline