Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03767296
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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.


Layout table for study information
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


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%)





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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767296


Locations
Layout table for location information
Belgium
University Hospital Ghent
Gent, Oost-Vlaanderen, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Layout table for investigator information
Principal Investigator: Caroline Vanpeteghem UZ Ghent

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03767296     History of Changes
Other Study ID Numbers: 2016/0644
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Ephedrine
Nasal Decongestants
Phenylephrine
Oxymetazoline
Pseudoephedrine
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
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