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临床试验/NCT01199237
NCT01199237已完成4 期

Effect of Anesthetic Choice (Sevoflurane Versus Desflurane) on Speed and Sustained Nature of Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2010年8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
入组人数
107
试验地点
2
主要终点
Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis.

研究概览

简要总结

Protective airway reflexes may be impaired in the postoperative period, creating the potential for aspiration of gastric contents, even after a patient exhibits appropriate response to command. Because assessment of airway reflex recovery is not possible in an intubated patient, the clinician must make an empiric decision as to when a patient is safe to extubate, and choose a combination of techniques least likely to result in pharyngeal impairment. Adequacy of reversal of neuromuscular block by cholinesterase inhibitors (e.g., neostigmine) is unpredictable, especially in the presence of profound paralysis, and tactile assessment of train-of four and sustained tetanus has shown poor correlation with objective assessments. Protective airway reflexes may also be impaired during early recovery by the anesthetics themselves, even when muscle relaxant has been avoided. In the absence of muscle relaxant the investigators previously demonstrated that patients receiving an anesthetic with higher tissue solubility, sevoflurane showed significantly greater impairment of swallowing up to 14 minutes after response to command compared to patients receiving an anesthetic with lower tissue solubility, desflurane. Therefore, we ask whether the combination of the more soluble anesthetic and the presence of neuromuscular block antagonized by neostigmine may create a multiplicative effect that might further prolong pharyngeal recovery. We plan to randomly assign 100 patients scheduled to undergo surgery with general anesthesia to a standardized anesthetic that includes 1) sevoflurane, rocuronium with 70 µg/kg neostigmine + 14 µg/kg glycopyrrolate antagonism (group S); or 2) desflurane, rocuronium with 70 µg/kg neostigmine + 14 µg/kg glycopyrrolate antagonism (group D). Airway reflex recovery will be judged as adequate by the patient's ability to swallow 20 mL of water without coughing or drooling 5, 10, 15, 20, 30 and 60 minutes after response to command. Anesthetic (sevoflurane or desflurane) will be discontinued after administration of reversal agent and recovery to TOF (train-of-four) ratio of 0.7.

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
Triple (Participant, 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

入选标准

  • ASA 1-2 patients
  • Age 18-65 years
  • body mass index (BMI) ≤ 35kg/m2
  • Planned surgery requiring general anesthesia lasting approximately 1.5-3.0 hours
  • Surgery requires or benefits from skeletal muscle relaxation
  • All must pass the baseline 20 mL water swallowing test as previously described.

排除标准

  • Pre-existing neuromuscular or central nervous system disorder
  • Known condition interfering with gastric emptying
  • Planned surgical procedure on the head or neck
  • Known liver disease
  • Serum creatinine > 1.5 mg/dL
  • Concurrent use of neuroleptic medications
  • Contraindication or previous adverse response to any of the study drugs
  • Active asthma or reactive airways disease
  • Surgery where upright position or brief cough would be contraindicated
  • Inability to provide informed consent

研究组 & 干预措施

Sevoflurane

Active Comparator

Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

干预措施: Sevoflurane (Drug)

Sevoflurane

Active Comparator

Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

干预措施: Rocuronium (Drug)

Sevoflurane

Active Comparator

Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

干预措施: Neostigmine (Drug)

Sevoflurane

Active Comparator

Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

干预措施: Glycopyrrolate (Drug)

Desflurane

Active Comparator

Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

干预措施: Desflurane (Drug)

Desflurane

Active Comparator

Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

干预措施: Rocuronium (Drug)

Desflurane

Active Comparator

Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

干预措施: Neostigmine (Drug)

Desflurane

Active Comparator

Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)

干预措施: Glycopyrrolate (Drug)

结局指标

主要结局

Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis.

时间窗: At 2 minutes after response to command (T1).

The patient is judged by the primary anesthetist to be awake at time T1. At 2 minutes after T1, the patient was asked to swallow 20mL of water from a paper cup, and a blinded observer judged the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag.

次要结局

  • Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1)(Up to 1 hour post-operative)
  • Nausea and Vomiting(60 minutes after T1)
  • Time From Anesthetic Discontinuation to First Ability to Swallow(up to 60 minutes after T1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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