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临床试验/NCT01790464
NCT01790464已完成不适用

Glossopharyngeal Nerve Blockade for Awake Videolaryngoscopy Assisted Endotracheal Intubation in the Morbidly Obese

McGill University Health Centre/Research Institute of the McGill University Health Centre0 个研究点目标入组 24 人开始时间: 2012年4月最近更新:
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
24
主要终点
Gag score

研究概览

简要总结

Endotracheal intubation of the morbidly obese is often performed awake. This is performed after topical anesthesia of the patient's pharynx and larynx. There are many techniques used to perform topical anesthesia of the patient's airway, which include aerosolization of local anesthesia, topical application of local anesthesia, and nerve blockade using needles and local anesthesia. Reasons for failure of any awake tracheal intubation technique is excess gagging. The most effective method to adequately anesthetize the airway to decrease the amount of gagging is unknown. The investigators wish to assess if the instillation of local anesthesia soaked gauze next to the peritonsillar pillars will decrease the number of gagging episodes during awake video laryngoscopy assisted tracheal intubation of the morbidly obese.

详细描述

Research design 1.1 Study design Prospective randomized control trial. 1.2 Patients All morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital are eligible.

1.3 Exclusions We will exclude any patient with

  • moderate to severe systemic illness, i.e. American Society of Anesthesiologists (ASA) score of 4 or higher
  • inability to communicate in English or French
  • contraindications to the drugs used in the study 1.4 Recruitment Eligible patients admitted to Royal Victoria Hospital who do not have any of the exclusion criteria will be approached by one of the investigators in the recovery room, or in the preoperative clinic before the scheduled surgery. The study protocol will be explained and a consent form will be given to the patients. Patients will have time and opportunity to ask any questions before the consent will be signed.

1.5 Study protocol Patients will be prepared for surgery according to the routine guidelines established by the Departments of Surgery and Anesthesia at the Royal Victoria Hospital.

They will have an IV and peripheral arterial line inserted, and will have Canadian Anesthesia Society standard monitors placed. Glycopyrrolate 0.4 mg iv will be given to decrease secretions. Using a computer generated randomization table, patients will be assigned to a group that receives standard airway anesthesia with 20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked in normal saline (Control Group) or that receives 20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked with 2% lidocaine (Glossopharyngeal Group). Sedation will be administered using a remifentanyl intravenous infusion of 0.05 /min with an initial bolus of 0.4µg/kg, and intravenous midazolam 0.05 mg/kg. We will review the chart to obtain patient demographic data including patient age, height, weight, medications, and past medical histories. Baseline blood pressure, heart rate, will be recorded, and a blood sample will be drawn for lidocaine level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • All morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital are eligible.

排除标准

  • moderate to severe systemic illness, i.e. American Society of Anesthesiologists (ASA) score of 4 or higher
  • inability to communicate in English or French
  • contraindications to the drugs used in the study

研究组 & 干预措施

NS gauze

Placebo Comparator

Standard airway anesthesia with 20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked in normal saline (Control Group)

干预措施: placebo (Drug)

Lidocaine gauze

Active Comparator

20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked with 2% lidocaine (Glossopharyngeal Group).

干预措施: 2% Lidocaine (Drug)

结局指标

主要结局

Gag score

时间窗: 10 minutes

We wish to assess if the instillation of local anesthesia soaked gauze next to the peritonsillar pillars will decrease the number of gagging episodes during awake video laryngoscopy assisted tracheal intubation of the morbidly obese.

次要结局

  • Lidocaine serum level(40 minutes)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Albert Moore

Assistant Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

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