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临床试验/NCT03915561
NCT03915561Unknown2 期

Effect of Intravenous Dynastat on Postoperative Sore Throat: A Randomized Double-blinded Controlled Trial

Buddhist Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
140
试验地点
1
主要终点
The late incidence of POST

研究概览

简要总结

A postoperative sore throat (POST) after tracheal intubation is one of the most common postoperative problems causing dissatisfaction to participants, including sore throat, dry throat, cough, sputum, hoarseness and even dysphagia. Both nonpharmacological and pharmacological measures have been attempted to alleviate the incidence and severity of POST with variable success. Airway inflammation may be important in the pathogenesis of these symptoms in intubated participants but however, there was still no study to investigate the effect of cyclooxygenase-2 (COX-2) for the prevention of POST. So, the investigators' study will be the first one to investigate if perioperatively intravenous (IV) Dynastat injection can be used as a new indication for POST prevention.

详细描述

The investigators' study will be designed a two-arm, individually randomized, double-blind, placebo-controlled trial comparing two doses of 40mg Dynastat with placebo (0.9% saline) in participants who will receive noncardiac surgery under general anesthesia with tracheal intubation. The investigators will include participants of American Society of Anesthesiologists physical status 1 and 2, 20-65 years of age, requiring general anesthesia with endotracheal intubation (ETGA) for elective non-cardiac surgery will be enrolled. Besides, the anesthetic time after intubation will need 90 minutes at least. Those with a preexisting cough, hoarseness or a sore throat, smoker, history of asthma or chronic obstructive pulmonary disorder, vocal performer by occupation, recent or recurrent respiratory tract infection, risk factors for postoperative aspiration, obesity, pregnancy, and contraindication to Dynastat medications will be excluded. Anticipated difficult intubation, Mallampati grade >2, difficult mask ventilation requiring oral or nasal airway, Cormack and Lehane grade III and IV on laryngoscopy, intubation attempt >1, moderate to severe liver dysfunction (Child-Pugh score >7), severe renal dysfunction (Ccr < 30 ml/min), congestive heart failure (NYHA II-IV), and those requiring orogastric or nasogastric tubes will be other exclusion criteria. In the operating room, participants will receive study drug according to the group allocation. General anesthesia will be induced with IV fentanyl 2 μg/kg and propofol 2 mg/kg, followed by rocuronium 0.8 mg/kg. After achieving adequate time of neuromuscular blockade onset, an anesthesiologist (endotracheal tube intubation numbers > 500 times), unaware of the group allocation, will perform laryngoscopy in all the groups using standard 3 or 4 Macintosh blades. Polyvinylchloride endotracheal tubes (ETTs) with a 7-mm ID for male and 6.5-mm ID for female will be used for orotracheal intubation. Lubrication will be applied on the ETT. The cuff will be inflated with air to the point just capable of sealing leakage. The cuff pressure will be checked and adjusted to 25-30 cmH2O with the help of pressure gauge. At the end of surgery, the residual neuromuscular block will be antagonized with IV neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg. Gentle suctioning of oral secretions will be done with 12F soft suction catheter while limiting the suction pressure to 50 cmH2O before tracheal extubation. After tracheal extubation, participants will be transferred to the postanesthetic care unit. The following variables at the time of tracheal intubation and extubation will be recorded: Cormack and Lehane laryngoscopy score; resistance to ETT insertion (none/mild/moderate); the time to achieve intubation will be defined as the time from opening of mouth for insertion of laryngoscope blade to confirmed placement of ETT (assessed with chest auscultation and capnograph); application of external laryngeal pressure to aid endotracheal intubation; duration of tracheal intubation defined as the time from placement of ETT to its removal; repositioning of ETT; blood tinge on the suction catheter during oral suctioning; blood stain on ET after its removal; and total opioid consumption in the postoperative period. The investigators' primary subject will be the incidence of POST, and the main effects of Dynastat will be the primary interest. The incidence of POST will be also compared among the 2 groups. Secondary outcomes included the severity of POST, incidences and severity of cough, hoarseness, and dysphagia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The randomization list will be generated using computer sequence number, and patient allocation ratio will be 1:1. Written allocation group will be sealed in individual opaque envelopes marked externally only with study identification numbers. An anesthetic assistant not participating in the study prepared the drug solution after breaking the codes

入排标准

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

入选标准

  • American Society of Anesthesiologists physical status 1 and 2
  • Requiring general anesthesia with endotracheal intubation (ETGA) for elective non-cardiac surgery
  • The anesthetic time after intubation will need 90 minutes at least.

排除标准

  • Those with a preexisting cough, hoarseness or a sore throat
  • History of asthma or chronic obstructive pulmonary disorder
  • Vocal performer by occupation
  • Recent or recurrent respiratory tract infection
  • Risk factors for postoperative aspiration, for example obesity, pregnancy
  • Allergic reaction to Dynastat, acetylsalicylic acid, sulfonamide or NSAIDs.
  • Active GI bleeding or gastric ulcer
  • Third trimester and during lactation
  • Anticipated difficult intubation
  • Mallampati grade >2
  • Difficult mask ventilation requiring oral or nasal airway
  • Cormack and Lehane grade III and IV on laryngoscopy
  • Intubation attempt >1
  • Moderate to severe liver dysfunction (Child-Pugh score >7)
  • Severe renal dysfunction (Ccr < 30 ml/min)
  • Congestive heart failure (NYHA II-IV)
  • Those requiring orogastric or nasogastric tubes

研究组 & 干预措施

Study group

Active Comparator

This group will be received intravenous injection with 10ml transparent mixture solution with 40mg Dynastat and 0.9% saline twice

干预措施: Parecoxib Injectable Product (Drug)

Placebo

Placebo Comparator

This group will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice

干预措施: Normal saline (Drug)

结局指标

主要结局

The late incidence of POST

时间窗: The late incidence will be assessed at 24 hours after surgery

The late incidence of POST will be also compared among the 2 groups

The early incidence of POST

时间窗: The early incidence will be assessed between 1 and 2 hours after surgery

The early incidence of POST will be also compared among the 2 groups

次要结局

  • The early severity of POST(The early severity of POST will be assessed between 1 and 2 hours after surgery)
  • The late severity of POST(The late severity will be assessed at 24 hours after surgery)

研究者

发起方
Buddhist Tzu Chi General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Po-Kai Wang

Head of Pain Management

Buddhist Tzu Chi General Hospital

研究点 (1)

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