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临床试验/NCT03420937
NCT03420937已完成4 期

Deep Neuromuscular Block During General Anaesthesia in Laparoscopic (and Robotic Laparoscopic) Surgery and Its Potential Benefits for Certain Physiological Parameters in Perioperative Period

University Hospital Olomouc1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
138
试验地点
1
主要终点
Intraabdominal pressure IAP (mmHg)

研究概览

简要总结

The aim of this project is to show, whether the use of the deep neuromuscular block in certain laparoscopic robot-assisted surgery can positively influence main physiological functions compared to the use of standard neuromuscular block. Secondary outcome is to find out whether the targeted specific reversal of neuromuscular block by sugammadex improves and fastens the post-operative recovery of the patients.

详细描述

Adequate muscle relaxation during general anaesthesia is crucial for easy, uncomplicated and safe laparoscopic and robot-assisted surgery. Perfect abdominal wall relaxation facilitates surgical working conditions, which makes surgery safer, faster and easier to perform. Besides this indirect advantage, there could be obvious benefit for patients. This is a result of decreased negative pathophysiological consequences of an increased intraabdominal pressure (capnoperitoneum) on important organ systems (cardiovascular, breathing system, kidneys etc.) Complete muscle relaxation during general anaesthesia can be achieved by using higher doses of rocuronium (non-depolarizing aminosteroid muscle relaxant) and special anaesthetic technique called deep neuromuscular block (DNMB). The primary focus of the project is to test the potential advantages of DNMB compared to standard relaxation technique. Safe and efficient use of NMBA is an important precondition in restoring a patient´s full muscle strength at the end of anaesthesia, to prevent effects of residual block. Modern practice of anaesthesia offers an option for complete and immediate rocuronium induced block reversal by using its specific antagonist - sugammadex. Combination of DNMB approach and sugammadex reversal also provide potential benefits for perioperative course and patient recovery after surgery. Secondary objective of the project is to verify this facts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Age over 18 years
  • Informed Consent
  • Elective robotic radical prostatectomy
  • American Society of Anesthesiologists (ASA) status 1-3

排除标准

  • Inability to obtain Informed ConsentAge under 18 years
  • American Society of Anesthesiologists (ASA) status over 3
  • Indication for rapid sequence induction, signs of difficult airway severe neuromuscular, liver or renal disease
  • Known allergy to drugs used in the study
  • Malignant hyperthermia (medical history)

研究组 & 干预措施

Deep Neuromuscular Block

Experimental

Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Post-tetanic Count (PTC) = 1-2; PTC measurement every 4 min.

Intervention: Neuromuscular blockade reversal at the end of anesthesia: sugammadex 2 mg/kg iv (when PTC is 18-20 and TOF-count 0) or sugammadex 4 mg/kg iv (when PTC under 18).

Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1,5-2,5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv.

Extubation when patient is conscious and attained recovery from neuromuscular blockade to a TOF-ratio of at least 0,9.

干预措施: Sugammadex (Drug)

Moderate Neuromuscular Block

Experimental

Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Train-of-Four (TOF) count = 1-2, TOF-count measurement every 1 min. Intervention: Neuromuscular blockade reversal at the end of anesthesia: neostigmine 0.03 mg/kg iv + atropine 0.5-1.0 mg iv Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1.5-2.5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv Extubation when patient is conscious and attained the recovery from neuromuscular blockade to a TOF-ratio of at least 0,9.

干预措施: Neostigmine, Atropin Biotika (Drug)

结局指标

主要结局

Intraabdominal pressure IAP (mmHg)

时间窗: During surgery

Pressure in the abdominal cavity during capnoperitoneum

Surgical conditions SRS

时间窗: Perioperative period

Describes the quality of surgical conditions as reported by surgeon

次要结局

  • Post-operative recovery(post-operative period (1 week))
  • Operating theatre time (min)(during anesthesia)

研究者

发起方
University Hospital Olomouc
申办方类型
Other
责任方
Principal Investigator
主要研究者

MUDr. Lenka Doubravska

MUDr. Lenka Doubravská

University Hospital Olomouc

研究点 (1)

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