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临床试验/NCT05751148
NCT05751148招募中不适用

Cardiovascular Effects of Intrathecal Hyperbaric Prilocaine or Bupivacaine in Surgery Under Spinal Anesthesia: A Multicenter Prospective Pilot Study Based on Non- Invasive Haemodynamic Monitoring

Centre Hospitalier Universitaire Saint Pierre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Change in cardiac output assessed by Clear Sight device

研究概览

简要总结

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.

详细描述

The investigators will conduct a double blinded pilot study in adult patients scheduled for elective surgery under spinal anesthesia. Selected interventions with few hemodynamic variations and minimal liquid shifts are knee arthroscopy, orthopedic lower limb surgery using a tourniquet, uni- or bilateral saphenectomy, ureteric stent insertion, inguinal hernia repair, vasectomy and penile circumcision.

  1. Population Patients will be included in the study, after reading, understanding, and signing the consent documents explaining the goals and the procedure of the study protocol. The study will take place in the departments of Anesthesiology and Pain Medicine of the Saint-Pierre University Hospital and Edith Cavell Interregional Hospital Group - Site Braine l'Alleud, in collaboration with their respective departments of surgery.

Considering that the present study is a pilot study, the number of patients to be included has been determined to be 30 in each study group for a total of 60 patients. The trial will end when the whole enrolled population will be subjected to the current protocol on elective surgery under spinal anesthesia.

The primary goal is to assess patients' cardiac output variation between the pre-spinal period and 20 minutes after intrathecal anesthesia.

Following ethics committee approval and informed signed consent, enrolled patients will be assigned after randomization into 2 groups

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 165 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

排除标准

  • 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

研究组 & 干预措施

Group 1: Hyperbaric Bupivacaine

Active Comparator

干预措施: Hyperbaric bupivacaïne (Drug)

Group 2: Hyperbaric Prilocaine

Active Comparator

干预措施: Hyperbaric prilocaïne (Drug)

结局指标

主要结局

Change in cardiac output assessed by Clear Sight device

时间窗: Up to two hours post surgery

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).

Change in cardiac output assessed by transthoracic Ultrasound

时间窗: Up to two hours post surgery

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).

Stroke Volume Variation assessed by the Clear Sight device

时间窗: Up to two hours post surgery

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).

Stroke Volume Variation assessed by transthoracic Ultrasound

时间窗: Up to two hours post surgery

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).

次要结局

  • 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)
  • Angiotensine(Up to two hours post surgery)
  • Pro-BNP(Up to two hours post surgery)
  • Total Vasopressor Dose(Up to two hours post surgery)
  • Bradycardia episodes(Up to two hours post surgery)
  • Surgeon's Satisfaction(Through surgery completion, an average of one hour after spinal anesthesia)
  • Patient's satisfaction(Up to two hours post surgery)

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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