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临床试验/NCT04941040
NCT04941040已完成1 期

Hemodynamic Effects of Opioid Free Anesthesia Versus Opioid Anesthesia on Adult Patients Undergoing Craniotomies for Supratentorial Tumors. Randomized Controlled Trial

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Percentage of patients experiencing a change in mean arterial pressure at time of Burr Hole

研究概览

简要总结

Hemodynamic control during craniotomies can be a bit hectic specially during periods of intense noxious stimulation. For long anesthesiologists used high doses of opioids such as fentanyl and remifentanyl to provide analgesia with a good hemodynamic control during intraoperative period in patients undergoing craniotomies. However, the use of opioids was not devoid of side effects. Exploring other anesthetic plans using multiple opioid free anesthetic adjuvants that have analgesic effects given together in small doses appear to be appealing plan. This idea is the basis of our proposed study in which we compare the hemodynamic effects of using opioid free anesthesia versus opioid anesthesia in cranial surgeries.

详细描述

Anesthesia for craniotomies can be very challenging because of the presence of periods of noxious stimuli that interposes with periods of little stimulation which makes hemodynamic control a little bit more complicated. Intraoperative episodes of hypertension during periods of intense stimulations and early postoperative hypertension may lead to serious complications as post craniotomy intracranial hemorrhage and vasogenic brain edema. Anesthetic techniques based on usage of high doses of potent opioid analgesics such as fentanyl and remifentanil have been widely popular among anesthesiologists. However, the intra operative use of large bolus doses or continuous infusions of potent opioids may be associated with postoperative hyperalgesia and increased analgesic consumption.

More recently, concerns have arisen about impaired healing,immunosuppression,and worsening of oncologic outcomes with systemic opioids. Another technique that started gaining its popularity is opioid free anesthesia (OFA) technique whose corner stone is depending on multiple anesthetic adjuvants that have analgesic effects, , therefore when given together in small doses they result in good anesthesia with less side effects and faster recovery compared with opioids. This technique has been successfully used in anesthesia for bariatric surgeries combining multiple drugs as dexmedetomidine, lidocaine, ketamine, ketorolac and magnesium.

Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, anxiolytic and analgesic properties that has minimal effects on respiratory drive. Although preoperative intravenous dexmedetomidine administration is associated with a reduction in postoperative pain intensity, analgesic consumption and nausea, the analgesic property of dexmedetomidine is less effective compared with opioids. Intravenous lidocaine has been described as having analgesic, anti-hyperalgesic, and anti-inflammatory properties. Intravenous lidocaine infusion in the perioperative period is safe and has clear advantages, such as decreased intra operative anesthetic requirements, lower pain scores, reduced postoperative analgesic requirements, as well as faster recovery. In addition to ketamine magnesium is also reported to enhance analgesia by blocking NMDA receptor, also magnesium has the properties of a sympatholytic and has been introduced as a safe component of balanced anesthesia.

This comparative study between Opioid free anesthesia (OFA) and Opioid anesthesia (OA) aims to compare the effect of both techniques on intra operative hemodynamics, intracranial tension and recovery in cranial surgeries for supratentorial tumors.

After obtaining an informed written consent from the patients or their responsible relative, patients will be divided into 2 groups randomly using computer software (research randomizer.org); Opioid free Anesthesia group (OFA) and Opioid Anesthesia group (OA). To assure blindness, numbers will be concealed by closed envelope, analgesic infusions will prepared by a clinical pharmacist not included in data collection and the attending anesthetist will be blinded to the type of analgesic solution injected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA Ι and II.
  • Patients undergoing surgeries for removal of supratentorial tumors.
  • Age (18-60) years.
  • Both sexes.

排除标准

  • Impaired renal functions.
  • Systemic hypertension.
  • Dysrhythmia.
  • Heart failure.
  • Glasgow coma scale less than
  • The need for postoperative ventilation.
  • History of allergy to the study drugs.
  • Surgeries lasting more than 6 hours.
  • Pregnancy.
  • Bronchial asthma

研究组 & 干预措施

Opioid free anesthesia

Experimental

patients are going to receive intraoperative analgesics other than opioids

干预措施: Opioid free anesthetics (Drug)

Opioid anesthesia

Active Comparator

patients are going to receive intraoperative opioid analgesics

干预措施: Opioid Anesthetics (Drug)

结局指标

主要结局

Percentage of patients experiencing a change in mean arterial pressure at time of Burr Hole

时间窗: During Burr hole surgery

Defined as recording an increase or decrease of the mean arterial blood pressure by more than 25 % from baseline readings at the time of burr hole

次要结局

  • Systolic blood pressure (SBP) in mmhg(Baseline, pre-induction, pre-intubation, after intubation, skin incision, burr hole, dural incision, dural closure, skin closure, every 30 minutes intraoperative till extubation, time of extubation, every 15 minutes for 2 hours in PACU.)
  • Mean arterial blood pressure (MAP) in mmhg(Baseline, pre-induction, pre-intubation, after intubation, skin incision, burr hole, dural incision, dural closure, skin closure, every 30 minutes intraoperative till extubation, time of extubation, every 15 minutes for 2 hours in PACU.)
  • HR (heart rate) in beats/min(Baseline, pre-induction, pre-intubation, after intubation, skin incision, burr hole, dural incision, dural closure, skin closure, every 30 minutes intraoperative till extubation, time of extubation, every 15 minutes for 2 hours in PACU.)
  • Brain relaxation score(At the time of dural incision)
  • Number of patients requiring antihypertensive medication(Throughout the operation)
  • Number of patients requiring medication to increase blood pressure(Throughout the operation)
  • Time to extubation(At the end of the operation, the time from the discontinuation of inhalation agents till extubation)
  • Ramsay Sedation Scale (RSS)(every 30 minutes for 2 hours postoperative)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Samir Fahmy

Assistant professor of Anesthesia, ICU and pain medicine

Kasr El Aini Hospital

研究点 (1)

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