Influence of Continuous Administration of Phenylephrine Versus Dobutamine on Spinal Oxygen Saturation, Measured With Near-infrared Spectroscopy (NIRS).

NCT03846765 | Completed Phase 4 DMC

• 1 other identifier: 2018/1510
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effect of hemodynamic supportive medication on spinal vasculature, patients scheduled for arterial dilation of the lower limb were chosen as our study population. The spinal cord perfusion is not compromised in these patients, however, most patients suffer from hypotension during this kind of surgery, due to the non-invasive type of surgery and the vasodilating effects of the anesthetics. Therefore, continuous administration of vasoactive medication (phenylephrine or dobutamine) is often required in order to increase blood pressure. The aim of our study is to evaluate the effect of a continuous administration of phenylephrine or dobutamine on the spinal oxygenation, assessed by NIRS.

Conditions

Nfuence of Vasoactive Medication on Spinal Oxygenation

Keywords

spinal oxygenation; NIRS

Outcome Measures

Primary Outcomes (1)

• Spinal oxygen saturation measured by NIRS

  Spinal oxygen saturation measured by NIRS

  from intubation until 30 minutes after intubation

Secondary Outcomes (2)

• Cerebral oxygen saturation

  from intubation until 30 minutes after intubation

• Deltoid muscle oxygen saturation

  from intubation until 30 minutes after intubation

Study Arms (2)

Phenylephrine continuous infusion

EXPERIMENTAL

Drug: Phenylephrine

Dobutamine continuous infusion

EXPERIMENTAL

Drug: Dobutamine

Interventions

Phenylephrine DRUG

Phenylephrine will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased. Phenylephrine will be started at 0,2 μg/kg/min and adjusted according to the patient's hemodynamic status. The dose will be adjusted to MAP during a 30-minute study period.

Phenylephrine continuous infusion

Dobutamine DRUG

Dobutamine will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased. Dobutamine will be started at 2 μg/kg/min; and adjusted according to the patient's hemodynamic status .The dose will be adjusted to MAP during a 30-minute study period.

Dobutamine continuous infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18y
• Patient is scheduled for dilation of arterial blood vessels of the lower limb

You may not qualify if:

• Age \< 18y
• BMI \> 30
• severe valvular disease
• previous aortic surgery
• paraplegia/ paraparesis
• kidney replacement therapy
• pacemaker
• pregnancy
• lactating participants
• preoperative use of ACE inhibitors.
• No sinus rhythm on preoperative ECG or at induction of anesthesia (patients with a history of atrial fibrillation can be included if they have a sinus rhythm on their preoperative ECG)

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Phenylephrine; Dobutamine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Catecholamines; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Caroline Vanpeteghem, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 20, 2019
• Study Start: July 4, 2019
• Primary Completion: May 22, 2021
• Study Completion: November 10, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)