Cardiovascular Effects of Intrathecal Hyperbaric Prilocaine or Bupivacaine in Surgery Under Spinal Anesthesia

NCT05751148 | Unknown

• 1 other identifier: B0762023230106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia remains a mainstay in lower limbs- as in day-case surgeries as well. It consists in injecting a local anesthetic drug into the intrathecal space of a patient's spinal canal. To achieve a suitable sensory and motor block for elective or emergent surgery, the anesthetist must adapt his choice of local anesthetic to the surgery's requirements and the patient's comorbidities, too. Spinal anesthesia is often associated with adverse cardiovascular events, notably hypotension which is a major concern in current anesthetic practice, especially in specific patient populations. Spinal induced hypotension is reported to be commonly related to the sympathetic block level and may be linked to perioperative cardiac and renal complications. Several mechanisms might play a role in the incidence of perioperative hypotension after spinal puncture. A decrease in peripheric systemic vascular resistance from arterial vasodilatation, a reduction of cardiac output due to a decrease in preload from a redistribution of venous blood into lower limbs or even an occurrence or increment of cardiac dysfunction, might compound proper blood flow towards noble organs such as brain, heart and kidneys. Spinal induced hypotension may also be related to a direct reduction of cardiac contractibility by the local anesthetic injection. Compensating mechanisms might be inhibited depending on the level of sympathetic blockade, usually related to the dose of the local anesthetic. Former studies found that intrinsic left ventricular depression might occur during spinal anesthesia as left ventricular volumes per se remain stable. One noticed that diastolic and systolic function (i.e., ventricular outflow tract velocity) decreased significantly after intrathecal levobupivacaine plus fentanyl injection based on transthoracic ultrasound assessment. Other authors use Pro-Brain Natriuretic Peptide to assess myocardial stress induced by surgery and anesthetic management. Other serum markers such as Cortisol, Adreno Cortico-Trope Hormone, Angiotensin are identified to screen and monitor myocardial stress as for instance acute myocardial dysfunction. Hyperbaric prilocaine is an intermediate-acting local anesthetic, whereas bupivacaine may be intermediate- or long-acting depending on the employed dose. Both drugs provide comparable sensory and motor block that meet the anesthesia level requirements in various surgical procedures. In regard to the hemodynamic effects, hypotension has been largely reported following hyperbaric bupivacaine in a dose-dependent way. However, discrepancy exists between the rare studies having investigated prilocaine's effects, probably related to the methodology and the employed doses. Moreover, the hemodynamics effects of these local anesthetics have been barely specifically investigated in a non-cesarean section context. The aim of this study is to compare the cardiovascular effects inflicted by hyperbaric prilocaine and bupivacaine under spinal anesthesia. Cardiovascular response will be assessed by non-invasive hemodynamic monitoring whereas metabolic stress will be evaluated using serum stress markers.

Conditions

Spinal Anesthesia; Cardiac Toxicity

Keywords

Hyperbaric Bupivacaine; Hyperbaric Prilocaine; Non-Invasive Hemodynamic Assessment; Clear Sight Edwards; Cardiac Ultrasound; Cardiac Output; Stroke Volume Variation

Outcome Measures

Primary Outcomes (4)

• Change in cardiac output assessed by Clear Sight device

  Cardiac output (liters per minute) will be assessed by the Clear Sight non-invasive hemodynamic system before spinal anesthesia (baseline), 20 minutes after spinal anesthesia and before discharge from the post anesthesia care unit (PACU).

  Up to two hours post surgery

• Change in cardiac output assessed by transthoracic Ultrasound

  Cardiac output (liters per minute) will be assessed by ultrasound assessment before spinal anesthesia (baseline), 20 minutes after spinal anesthesia and before discharge from the post anesthesia care unit (PACU).

  Up to two hours post surgery

• Stroke Volume Variation assessed by the Clear Sight device

  Stroke volume variation (%) will be assessed by the Clear Sight non-invasive hemodynamic system before spinal anesthesia, 20 minutes after spinal anesthesia and before discharge from the post anesthesia care unit (PACU).

  Up to two hours post surgery

• Stroke Volume Variation assessed by transthoracic Ultrasound

  Stroke volume variation (%)will be assessed by ultrasound assessment before spinal anesthesia, 20 minutes after spinal anesthesia and before discharge from the post anesthesia care unit (PACU).

  Up to two hours post surgery

Secondary Outcomes (11)

• Highest dermatome level

  20 minutes after spinal anesthesia

• Motor block

  20 minutes after spinal anesthesia

• Adrenocorticotropic Hormone (ACTH)

  Up to two hours post surgery

• Cortisol

  Up to two hours post surgery

• Dosage of Neuro-Inflammatory Markers

  Up to two hours post surgery

Study Arms (2)

Group 1: Hyperbaric Bupivacaine

ACTIVE COMPARATOR

Drug: Hyperbaric bupivacaïne

Group 2: Hyperbaric Prilocaine

ACTIVE COMPARATOR

Drug: Hyperbaric prilocaïne

Interventions

Hyperbaric bupivacaïne DRUG

Spinal anesthesia with 10mg of hyperbaric bupivacaïne. A syringe filled with 2 mL of hyperbaric bupivacaïne + 0,5 ml of saline solution

Also known as: Hyperbaric Marcaïne

Group 1: Hyperbaric Bupivacaine

Hyperbaric prilocaïne DRUG

Spinal anesthesia with 50mg of hyperbaric prilocaïne. A syringe filled with 2,5 mL of hyperbaric prilocaïne

Also known as: Tachipri

Group 2: Hyperbaric Prilocaine

Eligibility Criteria

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

You may qualify if:

• Male
• cm \< x \< 180 cm
• Aged of 18 or more and less than 65
• Elective surgery under spinal anesthesia
• American Society of Anesthesiology (ASA) I or II

You may not qualify if:

• History of heart disease: ischemic or valvular
• Atrial fibrillation
• Cardiotropic medication
• Cardiovascular disease history
• Norepinephrine uptake medication
• Urgent surgery
• History of narrow spinal canal
• Hemostasis abnormalities or local skin infection
• Hypersensitivity to local anesthetics
• Failure of spinal anesthesia leading to plan change during surgery
• Patient's refusal

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

Saint Pierre University Hospital

Brussels, 1000, Belgium

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Panayota Kapessidou, MD. PhD.

  Centre Hospitalier Universitaire Saint Pierre

  STUDY DIRECTOR

Central Study Contacts

Daniel Patricio, MD.

CONTACT

025354286; daniel.patricio@stpierre-bru.be

Panayota Kapessidou, MD. PhD.

CONTACT

025353750; panayota.kapessidou@stpierre-bru.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: March 2, 2023
• Study Start: March 22, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)