Opioid Sparing Anesthesia in Patients With Liver Cirrhosis Undergoing Liver Resection: A Controlled Randomized Double Blind Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intraoperative fentanyl requirements
研究概览
简要总结
This randomized clinical trial will investigate the opioid sparing effect of dexmedetomidine and ketmine infusion in cirrhotic patients undergoing liver resection
详细描述
Patient enrollment will start after approval of the study protocol by the local Ethics and Research Committee and the Institutional Review Board (IRB) of the Departments of Anesthesia, ICU and Pain Management and the National Liver Institute, Faculty of Medicine, Menoufia University. The study will be conducted in the Anesthesia Department, National Liver Institute and will be registered with the ClinicalTrials.gov (http://www.clinicaltrials.gov) before patients enrollment.
The study will include adult patients with liver cirrhosis undergoing liver resection. Patients will be randomly allocated into one of the two study groups using an online randomization program (http://www.randomizer.org). Random allocation numbers will be concealed in opaque closed envelops. A written informed consent will be taken from each patient.
Five leads electrocardiography, pulse oximetry and peripheral perfusion index using masimo pulse oxymetry finger prope (Masimo, Irvine,CA, USA), end-tidal CO2, invasive arterial blood pressure, central venous pressure, The electrical cardiometry (EC) (ICON monitor; Cardiotronics Inc., La Jolla, CA, USA) for cardiac output monitoring (CO). oesophageal temperature, fraction inspired oxygen concentration, fraction inspired and expired desflurane. Bispectral index will be used to monitor the depth of anesthesia (BIS Covidien USA.), The neuromuscular function will be monitored using TOF-Watch SX (Schering-Plough, Swords, Co. Dublin, Ireland).
All patients fulfilling the study inclusion criteria will undergo a thorough clinical evaluation including laboratory assessment of liver and renal functions. Other diagnostic and/or laboratory workup will be requested by the attending anesthetist and the surgeon according to the patient clinical condition and the proposed surgical intervention.
Bilateral transversus abdominis plane (TAP) block:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with liver cirrhosis [Child A] aged 18 to 65 years undergoing liver resection.
- •American Society of Anesthesiologists class II-III.
排除标准
- •Renal or cardiac dysfunction
- •History of chronic pain
- •Alcohol or drug abuse
- •Analgesic use in last 24 hours before surgery
- •Major intraoperative hemodynamic instability
- •The need for postoperative ventilation
- •Psychiatric disorders
- •Inability to comprehend pain assessment
- •Allergy or contraindication to any of the study medications.
研究组 & 干预措施
Opioid-based group (OB)
.Patients in the opioid-based group will receive placebo boluses and infusions of saline.
The intra-operative hemodynamics target will be to maintain the mean arterial blood pressure and heart rate within 20% of baseline value. Significant hemodynamic alterations will be managed as follows:
Hypertension and/or tachycardia defined as more than 20% increase of the baseline readings will be managed by top-up doses of fentanyl 1µg/kg
干预措施: Opioid-based group (OB) (placebo/saline) (Drug)
Opioid sparing group (OS)
Patients in the Opioid Sparing group will receive a loading dose of dexmedetomidine (1µg/kg over 10 minutes). This will be followed by a fixed continuous maintenance infusion of 0.5µg/kg/hour. Furthermore, a single induction analgesic dose of 0.5 mg/kg ketamine will be given to all patients in the OS group. This will be followed by 0.25 mg/kg/h continuous maintenance infusion. Dexmedetomidine and ketamine infusions will be stopped 30 minutes prior to the conclusion of surgery.
The intra-operative hemodynamics target will be to maintain the mean arterial blood pressure and heart rate within 20% of baseline value. Significant hemodynamic alterations will be managed as follows:
Hypertension and/or tachycardia defined as more than 20% increase of the baseline readings will be managed by top-up doses of fentanyl 1µg/kg in the two study groups.
干预措施: Opioid sparing group (OS) (dexmedetomidine (PRECEDEX™ "dexmedetomidine hydrochloride" - Pfizer) and ketamine) (Drug)
结局指标
主要结局
Intraoperative fentanyl requirements
时间窗: Through operative time
Intraoperative fentanyl requirements in micrograms
次要结局
- Postoperative PCA fentanyl requirements(Postoperative over 48 hours)
- Incidence of bradycardia(Through operative time)
- Postoperative pain score (VAS) score(2 hours after extubation then every 6 hours for 48 hours)
- Incidence of severe postoperative opioid related adverse events(48 hours after extubation)
- Incidence of hypertension(Through operative time)
- Extubation time(Time from antagonist administration till extubation)
- ICU and hospital length of stay(Immediate postoperative to maximum of 28 days)
- Incidence of hypotension(Through operative time)
- Average required end-tidal desflurane(Through operative time)
- Surgical time(Through operative time)
- Anesthesia time(Through operative time)
研究者
Mohamed Ahmed Mohamed Youssef Ollaek
Lecturer
Cairo University