跳至主要内容
临床试验/NCT05497492
NCT05497492招募中不适用

Comparison of the Effects of Esketamine, Sufentanil, or Lidocaine Combined With Propofol on Tussis Reflection During Upper Gastroscopy: a Randomised, Two Centre, Three-blind, Controlled Trial

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年11月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
the frequency of tussis, nausea and vomiting, and/or body movements observed at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion.

研究概览

简要总结

the frequency of tussis, nausea and vomiting, and/or body movements observed at the insertion of the endoscope into the pharyngeal cavity or within 5 min of endoscope insertion.

详细描述

The patients are selected according to their inclusion and exclusion criteria for diagnostic upper GI endoscopy and informed consent. The patients will be divided into the four groups: P group (single administration of propofol), P + S group (administration of propofol and sufentanil in combination), P + K group (administration of propofol and esketamine in combination), and P + L group (administration of propofol and lidocaine in combination) (N = 100 per group). Baseline information will be collected and recorded before the operation. Anaesthetic drugs will be prepared by the nurses and anaesthetists on the day of the operation as follows: 0.9% normal saline (20 mL) for the P group, 0.5 μg/mL sufentanil (20 mL) for the P + S group, 1.5 mg/mL esketamine (20 mL) for the P + K group, and 10 mg/mL lidocaine (20 mL) for the P + L group. Before entering the operating room, the patients will be given lidocaine defoamer for gargling to open the upper limb vein and 5 mL/min Lactate Ringer solution. After entering the room, the patients will wear masks to inhale high-flow oxygen, and their vital signs will be monitored and recorded as Tire. Analgesic drugs (diluted to 20 mL according to different concentrations) prepared by the nurses will be slowly injected into their veins 5 min before examination for 30 s (the dose was calculated using the formula: the injected drug dose (ml) = the weight of the patient (kg)/10"; 1.5 mg/kg propofol will be intravenously administrated. . Multiple-dose administration is acceptable according to the state of the patient. The endoscope will be inserted when the eyelash reflex disappeared (sedation depth grade: deep sedation). Blood pressure will be recorded after every 3 min from the beginning of the examination, and HR, SpO2, and RR will be recorded simultaneously. The frequency and degree of tussis, nausea, and vomiting and/or body movements at endoscope insertion or within 5 min of insertion will be monitored. In case of any abnormalities, they should be described in detail, and appropriate doses of propofol should be added until the endoscope exits the teeth pad. During endoscopy, 2-4 mL of propofol should be added under the conditions of extended operation time, accelerated breathing, and elevated blood pressure and heart rate to maintain deep sedation. The patients will be transferred to a recovery room after the operation, and their vital signs will be recorded after every 5 min until the patients met the standard of leaving the hospital (Steward score ≥ 4) before discharge

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • allergic reaction to planned medication
  • gravis myasthenia
  • history of psychological problems or psychiatric disease
  • morbid obesity/obstructive sleep apnea
  • acute upper respiratory infections
  • asthma at acute stage
  • history of unregulated or malignant hypertension
  • history of significant ischemic heart disease or severe arrhythmia
  • severe liver or kidney dysfunction or coagulation disorders
  • acute upper GI haemorrhage with shock
  • severe anaemia
  • GI obstruction with gastric retention
  • seizure disorders
  • long-term history of sedative and analgesic drug use
  • increased intracranial pressure.

研究组 & 干预措施

P + L group

Experimental

administration of propofol and lidocaine in combination

干预措施: propofol and lidocaine (Drug)

P group

Active Comparator

single administration of propofol

干预措施: propofol (Drug)

P + S group

Experimental

administration of propofol and sufentanil in combination

干预措施: propofol and sufentanil (Drug)

P + K group

Experimental

administration of propofol and esketamine in combination

干预措施: propofol and esketamine (Drug)

结局指标

主要结局

the frequency of tussis, nausea and vomiting, and/or body movements observed at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion.

时间窗: an average of 5 minutes,at the insertion of the endoscope into the pharyngeal cavity or within 5 minutes of endoscope insertion

the frequency of tussis

次要结局

  • MMSE scores after operation(through study completion, an average of 1 year after operation)
  • incidence of postoperative adverse events(through study completion, an average of 1 year,)
  • propofol dosage during operation(through study completion, an average of 20 minutes,the time from insertion endoscopy to withdrawal of endoscopy)
  • incidence of perioperative adverse events(through study completion, an average of 1 year,the time from insertion endoscopy to withdrawal of endoscopy)
  • recovery time(an average of 30 minutes,the time from withdrawal of endoscopy to obeying verbal commands)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

已完成
4 期
Esketamine Sedation and Fentanyl Sedation in Pediatric Dental PatientsKetamineFentanylSedation Complication
NCT04597320Peking University48
Unknown
4 期
Effects of Esketamine on Postpartum DepressionPostpartum Depression
NCT05229913Qinghai University500
招募中
不适用
IV Ketamine Vs. in Esketamine for MDD TRDTreatment Resistant Depression
NCT06488586Gustavo Vazquez80
已完成
3 期
The effects of esketamine and treatment expectation in acute major depressive disorder:A pharmacological fMRI-studyMedical Dictionary for Regulatory Activities - 10037175Medical Dictionary for Regulatory Activities- 10081270Medical Dictionary for Regulatory Activities - 10057840
DRKS00024815Phillips Universität Marburg165
进行中(未招募)
1 期
The effects of esketamine and treatment expectation in acute major depressive disorderTo unravel the neural correlates of the interaction between positive expectation (high/low) and single dose antidepressant treatment (verum/placebo) with esketamine in patients with major depressive disorderMedDRA version: 20.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 21.1Level: LLTClassification code 10081270Term: Major depressive disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
EUCTR2020-000784-23-DEPhilipps-Universität Marburg176