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临床试验/NCT03441828
NCT03441828已完成不适用

Effects of Depth of Neuromuscular Block on Surgical Operating Conditions and on Time to Discharge From Post-anesthesia Care Unit in Patients Undergoing Gynecologic Laparoscopic Surgery: a Randomized Prospective Clinical Trial

Federico II University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年2月1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
已完成
发起方
入组人数
50
试验地点
1
主要终点
impact of a deep neuromuscular blockade on surgical conditions

研究概览

简要总结

Comparison of the impact of a deep neuromuscular blockade (TOF count = 0 and posttetanic count [PTC] 1-2) and a moderate neuromuscular blockade (TOF count= 1 - 3) on intraoperative surgical conditions assessed by the surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point) in patients undergoing laparosopy for benign gynecological pathologies.

详细描述

Objectives.

The primary outcome of the study is to compare the impact of a deep neuromuscular blockade (TOF count = 0 and posttetanic count [PTC] 1-2) and a moderate neuromuscular blockade (TOF count= 1 - 3) on intraoperative surgical conditions assessed by the surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point).

The use of low intraabdominal pressure (IAP) and its impact on the surgical operating conditions has not yet been adequately defined in the literature, although, it is reasonable to consider that a deep neuromuscular blockade may be beneficial1, especially in gynecologic laparoscopic surgery.2, 3

Secondary outcome is to compare the time to discharge from post-anesthesia care unit (PACU) assessed with the WAKE© score.4 As per protocol adopted in our institution, patients are evaluated with the Modified Aldrete Score5 before discharging from PACU. However the WAKE© score , whichis constructed from the basic 10-point Modified Aldrete Score, addsthe "Zero Tolerance Criteria". In fact, the WAKE© score assigns a score from 0 to 2 to motor function, blood pressure, level of consciousness, respiratory function and oxygen saturation (with a maximum score of 10), plus the Zero Tolerance Criteria which address the presence or absence of pain, postoperative nausea and vomiting (PONV), shivering, pruritus, and orthostatic symptoms. A patient can be discharged from PACU when the WAKE© score is ≥ 9 and when there are not present any zero tolerance criteria (no pain, PONV, shivering, pruritus, and orthostatic symptoms).

The use of low IAP associated with the use of a deep neuromuscular blockade may improve the respiratory function and reduce the postoperative pain and PONV,1, 6-8 thus reducing the time spent in PACU.

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
Single (Care Provider)

盲法说明

in the assessment of the surgical field quality surgeons are blind respect the level of neuromuscular block received by patients

入排标准

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

入选标准

  • Patients who give written informed consent to the study
  • Age: 18-60 years
  • ASA risk class: I - II
  • Elective gynecologic laparoscopic surgery lasting <60 min (excision of ovarian cyst, endometriosis)

排除标准

  • Lack of consent
  • Body Mass Index (BMI)> 30 Kg/m2
  • Patients with renal and hepatic dysfunction
  • Neuromuscular disorders
  • Known hypersensitivity to study drugs
  • Pregnant patients
  • Conversion to laparotomy

研究组 & 干预措施

Group DNMB

Experimental

Deep Neuromuscular Block group Intervention: maintenance of a deep neuromuscular block by infusion of rocuronium at the starting dose of 0.3-0.6 mg / kg / h, titrated to maintain a TOF count of 0, and a PTC between 1-2.

Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point)

干预措施: Quality of surgical field conditions (Procedure)

Group DNMB

Experimental

Deep Neuromuscular Block group Intervention: maintenance of a deep neuromuscular block by infusion of rocuronium at the starting dose of 0.3-0.6 mg / kg / h, titrated to maintain a TOF count of 0, and a PTC between 1-2.

Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point)

干预措施: Deep Neuromuscular Block (Drug)

Group MNMB

Active Comparator

Moderate Neuromuscular Block group Intervention: maintenance of a moderate neuromuscular block. neuromuscular blockade will be maintained with intravenous bolus of rocuronium (0.15-0.25 mg/kg) titrated to obtain a TOF count of 1-3.

Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point)

干预措施: Quality of surgical field conditions (Procedure)

Group MNMB

Active Comparator

Moderate Neuromuscular Block group Intervention: maintenance of a moderate neuromuscular block. neuromuscular blockade will be maintained with intravenous bolus of rocuronium (0.15-0.25 mg/kg) titrated to obtain a TOF count of 1-3.

Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point)

干预措施: Moderate Neuromuscular Block (Drug)

结局指标

主要结局

impact of a deep neuromuscular blockade on surgical conditions

时间窗: during surgery

impact of a deep neuromuscular blockade (TOF count = 0 and posttetanic count \[PTC\] 1-2) and a moderate neuromuscular blockade (TOF count= 1 - 3) on intraoperative surgical conditions assessed by the surgeon as a 5 points scale

次要结局

  • the time to discharge from post-anesthesia care unit(first 12 h post op)

研究者

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

Edoardo De Robertis

Associate Professor

Federico II University

研究点 (1)

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