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临床试验/NCT04276545
NCT04276545已完成3 期

Dexmedetomidine Improves the Surgical Field and Postoperative Recovery of Nasal Endoscopic Surgery

Eye & ENT Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
118
试验地点
1
主要终点
Evaluation of surgical field according to the scale reported by Boezaart A.P. in the two groups

研究概览

简要总结

Studies showed dexmedetomidine (DEX) could improve surgical field, but the effect for functional nasal endoscopic surgery (FESS) was unclear. The investigators explored IV administration of a single loading dose DEX (0.5μg/kg) for FESS, and IV administration of midazolam (0.05mg/kg) as a control with comparision of surgical field, haemodynamics, ventilation parameters and recovery.

详细描述

The participants received an induction of anesthesia with propofol 2-3 mg/kg, sufentanyl 0.2 μg/kg, and rocuronium 0.6 mg/kg, and then insertion of a flexible laryngeal mask airway was conducted using the index finger insertion technique by anesthesia providers with a minimum of four years endotracheal intubation experience. Mechanical ventilation parameters were as follows: pressure-controlled ventilation mode, ventilation pressure: 12, respiratory rate: 12, oxygen concentration: 50%. The maintenance of general anesthesia was performed with sevoflurane at minimum alveolar concentration of 1.3. After induction, a single loading dose DEX (0.5μg/kg) was IV infusion within 10 minutes, or IV administration of midazolam (0.05mg/kg). Heart rate, blood pressure, tidal volume, ventilation pressure and ETCO2 after insertion of a LMA, 10 minutes, 20 minutes, 30 minutes after drug infusion and transferred to PACU, besides heart rate and blood pressure were recorded before and after induction. Surgical field was evaluated at the time of 10 minutes and 20 minutes after drug infusion. Blood gas analysis was performed just transferred to PACU and before transferred to ward.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 120 participants who diagnosed with nasosinusitis
  • The participants need undergo functional nasal endoscopic surgery
  • The participants signed the informed consent

排除标准

  • The participants were excluded with any diseases about respiration, circulation, liver and kidney
  • The participants were rejected of the consent

研究组 & 干预措施

IV administration of dexmedetomidine

Experimental

IV administration of a single loading dose DEX (0.5μg/kg)

干预措施: IV administration of DEX to investigate the effects for functional nasal endoscopic surgery (Drug)

IV administration of dexmedetomidine

Experimental

IV administration of a single loading dose DEX (0.5μg/kg)

干预措施: IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery (Drug)

IV administration of midazolam

Active Comparator

IV administration of midazolam (0.05mg/kg)

干预措施: IV administration of DEX to investigate the effects for functional nasal endoscopic surgery (Drug)

IV administration of midazolam

Active Comparator

IV administration of midazolam (0.05mg/kg)

干预措施: IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery (Drug)

结局指标

主要结局

Evaluation of surgical field according to the scale reported by Boezaart A.P. in the two groups

时间窗: Through study completion, an average of 1 year

Levels of the scale reported by Boezaart A.P. as follows: 0. No bleeding. 1. Slight bleeding - no suctioning of blood required. 2. Slight bleeding - occasional suctioning required. Surgical field not threatened. 3. Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed. 4. Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed. 5. Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible. Evaluation of surgical field was carried out by Kruskal-Wallis H test.

次要结局

  • Comparision of heart rate and mean blood pressure during anesthesia in the two groups(Through study completion, an average of 1 year)
  • Comparision of recovery time and blood gas analysis in PACU in the two groups(Through study completion, an average of 1 year)

研究者

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

Jinhong Wu

Attending anesthesiologist

Eye & ENT Hospital of Fudan University

研究点 (1)

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