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临床试验/NCT03343080
NCT03343080已完成2 期

Lidocaine as an ETT Cuff Media in the Immediate Post-operative Cardiac Surgery Patient Population, and Its Effect on Sedation/Analgesia Requirements: a Pilot Study

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年7月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Mayo Clinic
入组人数
32
试验地点
1
主要终点
Total Sedation Requirements

研究概览

简要总结

Researchers will compare the effects of lidocaine versus air, as a way to fill the breathing tube cuff which is gently inflated to hold in place the trachea (airway) during surgery. Air is the traditional method used to inflate the breathing tube cuff. Researchers wish to find if lidocaine works better than air to facilitate tolerance to the breathing tube (decreased coughing, sore throat, hoarseness). They also want to learn more about its effectiveness for this particular surgical intervention.

详细描述

At the induction of anesthesia, Participants will be breathing 100% oxygen via a face mask and then, become anesthetized according to a standard protocol and at the discretion of the attending anesthesiologist. Participants will be receive fentanyl, lidocaine and either succinylcholine or vecuronium to facilitate tracheal intubation. Laryngoscopy will then be performed and the trachea intubated with a standard cuffed ETT. Inflation of the ETT cuff will be performed in accordance with the randomization of either air or 1.8% lidocaine/0.76% solution until such time as there is no air leak around the tube when administering positive pressure to 20 cm H2O. Anesthesia will be maintained with volatile anesthetic with or without a Propofol infusion. Vecuronium will be used to maintain the ulnar nerve train-of-four at 0-3 of four twitches. Lungs will be mechanically ventilated with tidal volumes of 6-8 mL/kg to maintain end-tidalCO2 concentration at 30-35 mm Hg. Anesthesia maintenance will occur until the near end of the surgical procedure. The volatile anesthetic will be discontinued and Propofol will be initiated via a continuous infusion to facilitate transportation to the intensive care unit (ICU). After arrival to the ICU, Neuromuscular blockade will then be antagonized with neostigmine and glycopyrrolate, and the pharynx being gently suctioned under direct vision. Mechanical ventilation to be maintained until swallowing or spontaneous respiration begins, and then, converted to assisted manual ventilation. Extubation will be performed when all of the following criteria are met: 1) full reversal of neuromuscular block (ulnar nerve T4/T1 ratio 1:1, with sustained tetanus at 50 Hz for 5 s and no fade); 2) spontaneous ventilation; and 3) the ability to follow verbal commands (eye opening or hand grip) or demonstrate purposeful unilateral movement (attempting self-extubation); 4) demonstration of hemodynamic stability; 5) adequate hemostasis with combined chest tube output < 100 ml/hour.

The Participant then will be closely monitored as a 1:1 by the room nurse, and by other staff (respiratory therapist, and ICU fellows and consultants) for toleration of the ventilator (coughing, double triggering, "bucking," etc.). on the cardiac surgical intensive care unit. Sedation amount will be recorded electronically once the patient lands in the ICU, until the time of extubation. A member from the study team will physically record "yes," or "no," on the form provided regarding the patient coughing, complaining of a sore throat or difficulty swallowing, having hoarseness or difficulty speaking.

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 (Investigator)

入排标准

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

入选标准

  • All patients > 18 years of age (male and female) who will receive general anesthesia for cardiac surgery at St. Mary's Hospital (SMH) in Rochester, Minnesota
  • Cardiac surgery includes: single valve repair, myectomy, cabbage, pericardectomy.
  • American Society of Anesthesiologists (ASA) physical status I-III

排除标准

  • Age < 18 years old at time of surgery
  • Patients who are not sent to the cardiac ICU post-operatively
  • Patients who are anticipated to have a difficult tracheal intubation
  • Patients having risk factors of postoperative aspiration of gastric contents
  • Patients who have respiratory disease or recent respiratory tract infection
  • > 1 attempt to secure an airway
  • Patients undergoing transcatheter aortic valve replacement (TAVR) procedures or any form of "robotic" procedures

研究组 & 干预措施

Buffered Lidocaine

Experimental

At the induction of anesthesia, patients will be breathing 100% oxygen via a face mask and then, become anesthetized according to a standard protocol and at the discretion of the attending anesthesiologist.

For cardiac surgery patients randomized to the buffered lidocaine arm, the operating room registered respiratory therapist (OR RRT) will inflate the endotracheal tube cuffs with the study drug containing 1.8% lidocaine plus 0.76% sodium bicarbonate until abatement of the air leak at 20 cm of water.

The intervention will take place while in the operating room. The room nurse anesthetist (CRNA) or anesthesiologist will be aware of the amount of solution instilled in the ETT cuff. The patient will remain intubated after the surgery is complete and will be taken to the cardiac surgical ICU.

干预措施: 1.8% lidocaine plus 0.76% sodium bicarbonate (Drug)

Air

Placebo Comparator

At the induction of anesthesia, patients will be breathing 100% oxygen via a face mask and then, become anesthetized according to a standard protocol and at the discretion of the attending anesthesiologist.

For cardiac surgery patients randomized to the air arm, the operating room registered respiratory therapist (OR RRT) will inflate the endotracheal tube cuffs with air until abatement of the air leak at 20 cm of water.

The intervention will take place while in the operating room. The room nurse anesthetist (CRNA) or anesthesiologist will be aware of the amount of air in the ETT cuff. The patient will remain intubated after the surgery is complete and will be taken to the cardiac surgical ICU.

干预措施: Air (Other)

结局指标

主要结局

Total Sedation Requirements

时间窗: baseline through extubation

Total amount of Propofol dose used as measured in total milligrams.

次要结局

  • Total Duration of Mechanical Ventilation(baseline through extubation)
  • Richmond Agitation-Sedation Score (RASS)(4 hours post-extubation)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Troy G. Seelhammer

Assistant Professor of Anesthesiology

Mayo Clinic

研究点 (1)

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