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临床试验/NCT04161508
NCT04161508Unknown不适用

Enhanced Recovery After Surgery in Elderly Patients: Effects of Sugammadex on Recovery After Anterior Cervical Spine Surgery

Taipei Veterans General Hospital, Taiwan0 个研究点目标入组 100 人开始时间: 2019年12月20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
入组人数
100
主要终点
mean time to 90% TOF ratio

研究概览

简要总结

Elderly patients are subjected to airway and other complications after cervical spine surgeries. The study aim to investigate the efficacy of sugammadex (vs. neostigmine) in the recovery after anterior cervical spine surgery.

详细描述

Cervical spine surgeries have been increasing for many years. In Taiwan, according to the data published by the Department of Statistics, Ministry of the Interior, the elderly population (≥ 65 years old) increased and comprised 14.4% of the whole population in March, 2018. The percentages is likely to rise to 20% after 8 years. Because cervical spine surgery is a procedure commonly performed in elderly patients, the increasing trend of cervical spine surgery will likely continue. Elderly patients experienced an increased odds of length of stay ≥ 5 days, pulmonary complications, cardiac compilations, venous thromboembolism, UTI, sepsis, and unplanned readmission after anterior cervical spine surgeries according to the literature. For example, in patients ≥ 65 years old undergoing cervical spine surgery, 9.80% patients experienced at least 1 complication or death. Patients of 70~74 years old (odds ratio [OR] =1.94, 95% confidence interval [CI] = 1.03~3.65) and patients with at least 1 postoperative complication (OR 9.59, 95% CI 5.17~17.80) had increased risks of unplanned readmissions. Patients ≥ 75 years old were at higher risk of developing a complication or death with an odds ratio (OR 1.72, 95% CI 1.13~2.61). Identification of factors and change the policy of standard care in elderly patients can improve surgical outcome. The elderly have a different physiological change, such as lower elimination of the anesthetics, resulting in the confusion or delaying of detecting complications after the surgery.

Airway complications after ACCS are not uncommon. This includes sorethroat, vocal cord paresis without overt symptoms, vocal cord palsy or dysphonia, and dysphagia. The incidence of voice and swallowing complaints is primarily published in the spine literature and is inconsistent with rates ranging between 0.4% and 71%. The discrepancy may result from differences in the measurements and timepoints. We have performed a preliminary observational study investigating postoperative dysphonia and dysphagia after anterior cervical spine surgeries. We demonstrated more patients score none or mild dysphonia after surgeries in groups receiving sugammadex as a reversal of muscle relaxants. Suggammadex is a unique neuromuscular reversal drug; modified γ-cyclodextrin that allows binding encapsulation of rocuronium. The rocuronium molecule (a modified steroid) bound within sugammadex's lipophilic core, is rendered unavailable to bind to the acetylcholine receptor at the neuromuscular junction and results in the revesal of the effect of neuromuscular blackade. As the preliminary observation was not a randomized, blinded study, whether sugammadex posses beneficial effect on postoerative dysphonia warrants investigation.

Enhanced Recovery After Surgery (ERAS) proposes a multimodal, evidence-based approach to perioperative care. The first goal of ERAS is the improvement of surgical outcomes and patient experience, with a final impact on a reduction in the hospital length of stay (LOS). The implementation of ERAS in spinal surgery is in the early stages. We believe the elements for ERAS should direct to the specific characteristics of surgery and surgical population. Therefore, our investigation for improving posteropative dyshonia and dysphagia will provide a important reference for choice of elements for ERAS of cervical spine surgeries in the future.

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
Double (Participant, Outcomes Assessor)

盲法说明

Randomization and drug preparation are executed by a nurse anesthetist according to the body weight of the patients. The nurse anesthetist is not responsible for perioperative anesthetic care, and outcome assessemnt. The volume of drugs is adjusted to 10 ml with addition of normal saline to become undifferent in appearance

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • anterior cervical spine surgery American society of anesthesiologist (ASA) physical status I~III

排除标准

  • unstable cervical spine requiring immobilization orthosis previous allgery to rocurium, sugammadex, and neostigmine anticipated difficult tracheal intubation preoperative sorethroat, dysphoina or dysphagia history, regardless of etiology lack of informed consent

研究组 & 干预措施

Sugammadex

Experimental

sugammadex 2 mg/ Kg for the reversal of neuromuscular blockade at the end of surgery

干预措施: Sugammadex Injection (Drug)

Neostigmine

Active Comparator

neostigmine 50 mcg/Kg + glycopyrrolate 10 mcg/kg for the reversal of neuromuscular blockade at the end of surgery

干预措施: Neostigmine Injection (Drug)

结局指标

主要结局

mean time to 90% TOF ratio

时间窗: up to postoperative 2 hour

time from injection of drug to train of four ratio to 90%

mean time to extubation

时间窗: up to postoperative 3 day

time from injection of drug to tracheal extubation

次要结局

  • postoperative sorethroat(postoperative Day 1, 2,3,7,10,30)
  • postoperative dysphonia(postoperative Day 1, 2,3,7,10,30)
  • postoperative dysphagia(postoperative Day 1, 2,3,7,10,30)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

vghtpe user

Ya-Chun Chu, MD, PhD, Chief of Division of Neuroanesthesia, department of Anesthesiology

Taipei Veterans General Hospital, Taiwan

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