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To Compare Effect of Sevoflurane Versus Desflurane on the Return of Swallowing Reflexes in the Elderly

2013年12月4日 更新者:Lee Fenky、University of Malaya

To Compare Effect of Sevoflurane Versus Desflurane on the Return of Protective Airway Reflexes in the Elderly Population

Anaesthesia and surgery has become more common in the elderly as the population survives longer. Anaesthesia in the elderly confers a higher risk which is related to the aging process and the diseases that accompany seniority. As such, there is a need to provide optimal anaesthetic management in order to minimize complications and risks perioperatively. One of the changes associated with ageing is the progressive decrease in protective laryngeal reflexes. Any depression of upper airway reflexes increases the chance of pulmonary aspiration and compromises the maintenance of the airway.

Desflurane is an inhalational agent strongly favored due to its lower solubility in blood, lean tissue and fat as compared to sevoflurane. This enables the agent to be quickly eliminated at the end of surgery, with minimal metabolic breakdown, thus facilitating more rapid emergence as compared to sevoflurane anesthesia in elderly undergoing general anaesthesia. McKay et al conducted a study in 2005 in US, which showed that the choice of inhalational agent itself can influence the return of protective airway reflexes. In the study, the inhalational agent sevoflurane was found to cause significant impairment of swallowing, in comparison with desflurane(1). However, the aforementioned study focussed on the general population. As such, the purpose of this study is to determine whether the choice of inhalational anesthetic (sevoflurane versus desflurane) has similar influence on the return of protective airway reflexes in the geriatric population in Malaysia, and whether the significance is greater in the elderly population.

研究概览

地位

完全的

条件

详细说明

This is a prospective, double-blind, randomized controlled trial by single operator. American Society of Anaesthesiologists' classification of physical status I-II male and female patients aged 60-85 year scheduled to have general anesthesia for surgical procedures were recruited. Patients recruited will be given 20mls of water to swallow in the upright position prior to surgery after obtaining informed consent. All patients enrolled are judged to have adequate swallowing if no coughing or drooling occurred after the water passed into the mouth, and no water remained in the oropharynx upon subsequent visual inspection.

The anaesthetist in charge of the patients enrolled in the study will be given a sealed envelope containing the name of the randomised gas to be used for the patient. At the end of surgery, an observer who is blinded to the anaesthethic allocation will record the relevant data. The blinded observer determined the time to first appropriate response to command (asking the patient to 'open his/her eyes' or squeezing the observer's hand, state his/her name or state date of birth) every 30s after discontinuation of anesthetic administration and removal of LMA. Exactly 5 minutes after appropriate verbal response, patient was asked to swallow 20mls of water in a 30 degree upright position. Successful swallowing is defined as ingestion of the 20mls of water without coughing or drooling. If swallowing was successful, the study was concluded. If it was unsuccessful, the patient was asked to swallow at 5, 10, 15, 20, 25 and 30 minutes, with termination of participation after successful swallowing. A stopwatch will be used to time the duration to recovery.

A study sample size of 60 is selected, with a power of 0.80 taken as the standard of adequacy. A p-value of < 0.05 is taken as the criteria for the test result to be statistically significant and data will be analyzed.

研究类型

介入性

注册 (实际的)

51

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Kuala Lumpur、马来西亚、59100
        • University Malaya Medical Centre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 至 85年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 60-85 years' old
  • Both male and female patients
  • ASA I-II
  • Body mass index (BMI) ≤ 30 kg/m2
  • Elective surgery under general anaesthesia with the use of laryngeal mask airway (LMA) / LMA Proseal / LMA Supreme
  • Type of surgery: Urogynecological, General Surgery, Orthopedics, Eye, Vascular, Plastic
  • Surgery/anaesthesia lasting for 0.5-3 hours

Exclusion Criteria:

  • Patients with difficulty in swallowing, preexisting neuromuscular or central nervous system disorder
  • Patients undergoing intra abdominal, thoracic, face, nasal or throat surgery
  • Known condition interfering with gastric emptying
  • Patients with cognitive or hearing impairment and inability to provide informed consent
  • ASA III-IV patients
  • Use of muscle relaxant during the course of general anesthesia
  • Contraindication or previous adverse response to any of the study drugs

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器:Desflurane
Patient receiving Desflurane for maintenance of general anaesthesia
有源比较器:Sevoflurane
Patient receiving Sevoflurane for maintenance of general anaesthesia
其他名称:
  • 七氟烷

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The recovery of ability to swallow 20mls of water at designated time frame after response to command
大体时间:up to 30 minutes after appropriate verbal response
Patient is asked to swallow 20mls of water every 5 minutes after appropriate verbal response. Successful swallowing is defined as swallowing 20mls of water without drooling, coughing, choking or nausea. If patient fails to swallow at the first 5 minutes, the test will be repeated every 5 minutes until 30 minutes are up or until patient is able to swallow successfully
up to 30 minutes after appropriate verbal response

次要结果测量

结果测量
措施说明
大体时间
Emergence and immediate recovery times after discontinuation of sevoflurane versus desflurane
大体时间:A stopwatch will be used to record the time (in minutes) of patient obeying verbal command
Emergence and immediate recovery times are the time taken by patient to open eyes to call or grip the observer's hands, and obey simple commands ie state his/her name or state his/her date of birth. A Stopwatch is used to record the time from discontinuation of the anaesthetic agent used to the emergence and immediate recovery times
A stopwatch will be used to record the time (in minutes) of patient obeying verbal command

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Lee Fenky, MBBS (IMU)、University of Malaya

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年3月1日

初级完成 (实际的)

2013年4月1日

研究完成 (实际的)

2013年4月1日

研究注册日期

首次提交

2013年4月6日

首先提交符合 QC 标准的

2013年4月14日

首次发布 (估计)

2013年4月17日

研究记录更新

最后更新发布 (估计)

2013年12月5日

上次提交的符合 QC 标准的更新

2013年12月4日

最后验证

2013年12月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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