跳至主要内容
临床试验/NCT04817033
NCT04817033已完成4 期

Comparison of Intraoperative Complications in Patients With or Without High Risk for Obstructive Sleep Apnea During Sedation With Midazolam or Dexmedetomidine Within Transurethral Resections of Bladder and Prostate

University Hospital of Split1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
115
试验地点
1
主要终点
Coughing and restlessness

研究概览

简要总结

Light to moderate sedation is recommended during surgery with spinal anesthesia . This study is exploring which sedation drug is better, midazolam or dexmedetomidine for transurethral resection of bladder and prostate in patients with or without high risk for obstructive sleep apnea (OSA). Patients were divided in two groups regarding OSA risk, and each group received midazolam or dexmedetomidine for sedation. Investigators observed intraoperative complications of airway and factors that are disturbing surgeon(movement due to participants coughing and restlessness) because one could puncture bladder or prostate and cause perforation.

详细描述

All participants were premedicated with diazepam 5mg 12 hours and 1 hour before surgery. Thromboprophylaxis (enoxaparin 4000-6000 IU) depending on the body weight was given at least 12 hours before surgery.

Participants were divided by STOP-BANG(Snoring history, Tired during the day, Observed stop breathing while sleep, High blood pressure, BMI more than 35 kg/m2, Age more than 50 years, Neck circumference more than 40 cm and male Gender) questionnaire into one of two groups: high OSA and low&medium OSA. Each group was then allocated by permuted block randomisation into midazolam or dexmedetomidine group. The randomisation list was obtained from R program. The group allocations were contained in closed envelope that were opened before surgery after the completed enrollment procedure.

Participants got IV cannula with switch for continuous intravenous infusion in operating theatre. Non invasive monitoring (electrodes for ECG, blood pressure cuff and pulse oximeter) was placed before induction of spinal anesthesia. Skin was disinfected and 40mg of 2% Lidocaine was given subcutaneously at lumbar vertebrae 3/4 level. 25 G spinal needle was used and after dura and arachnoidea were pierced 12.5-15 mg of 0.5% Levobupivacaine was applied. Participants were then positioned in uniform lithotomy position and 9cm pillow was inserted. After sensory block, defined as the absence of pain at T10 dermatome, was induced by needle-tip test by the anaesthesiologist, the surgery was initiated.

Time after subarachnoid block was T0 and sedation with midazolam or dexmedetomidine was started via continuous intravenous infusion. Midazolam was started with 0.25 mg/kg of ideal body mass, and dexmedetomidine with 0.5 ug/kg through 10 minutes. Every 10 minutes sedation level was observed with Ramsay sedation scale (RSS). Drug was titrated to achieve RSS of 4 or 5 (closed eyes and patient exhibited brisk or sluggish response to light glabellar tap or loud auditory stimulus). Independent blinded doctor was assessing RSS level, vital parameters and signs of airway obstruction every 10 minutes. Every 10 minutes systolic, diastolic and mean arterial pressure(MAP) were noticed along with heart rate, oxygen saturation by pulse oximetry(SpO2), RSS level and adverse intraoperative events: snoring as sign of airway obstruction, cough and restlessness as disturbing factors to surgeon. If peripheral oxygen fell below 90% supplemental oxygen was delivered by facemask with reservoir bag at flow of 10 L/min. End tidal carbon dioxide(CO2)was measured for detection of possible apnea. If oxygenation was still inadequate chin lift and jaw thrust maneuver were performed and oropharyngeal airway was inserted if needed. If heart rate fell below 50 bpm atropine 0.1 mg/kg was given and if systolic blood pressure fell below 100 mmHg(or MAP < 65 mmHg) ephedrine 5mg bolus was given. Total crystalloid infusion volume was noticed at the end of surgery. All measurements were performed every 10 minutes and 1 hour after surgery in urology intensive care. High risk OSA participants underwent cardiorespiratory polygraphy at Center for sleep medicine Split.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective transurethral resection of bladder and prostate
  • American Society of Anesthesiologists (ASA) physical status classification system: I, II, III

排除标准

  • regional anesthesia contraindications
  • American Society of Anesthesiologists (ASA) physical status classification system: IV
  • Atrioventricular cardiac block II and III degree
  • Psychotic disorders
  • Participants with tracheostomy
  • Allergy on Dexmedetomidine or Midazolam

研究组 & 干预措施

High risk OSA Dexmedetomidine

Active Comparator

High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

干预措施: Spinal anesthesia with intraoperative dexmedetomidine sedation (Procedure)

High risk OSA Dexmedetomidine

Active Comparator

High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

干预措施: Dexmedetomidine (Drug)

High risk OSA Midazolam

Active Comparator

High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

干预措施: Spinal anesthesia with intraoperative midazolam sedation (Procedure)

High risk OSA Midazolam

Active Comparator

High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

干预措施: Midazolam (Drug)

Low&Medium OSA Dexmedetomidine

Active Comparator

Low&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

干预措施: Spinal anesthesia with intraoperative dexmedetomidine sedation (Procedure)

Low&Medium OSA Dexmedetomidine

Active Comparator

Low&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

干预措施: Dexmedetomidine (Drug)

Low&Medium OSA Midazolam

Active Comparator

Low&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

干预措施: Spinal anesthesia with intraoperative midazolam sedation (Procedure)

Low&Medium OSA Midazolam

Active Comparator

Low&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

干预措施: Midazolam (Drug)

结局指标

主要结局

Coughing and restlessness

时间窗: During surgery

Participants have to be relaxed and calm during surgery and sedation. Theirs coughing and restlessness result in movement that is disturbing to surgeon because they could puncture bladder/prostate with resectoscope and cause perforation. So when surgeon complains about participants movement due to theirs coughing and restlessness investigators check that on list.

Cardiorespiratory polygraphy

时间窗: up to 30 weeks

OSA classification with apnea hypopnea index(AHI) for High risk OSA participants

Airway complications

时间窗: During surgery

Snoring detection, SpO2 and patient respiration monitoring, If SpO2 fell below 90% supplemental oxygen was delivered by facemask with reservoir bag at flow of 10 L/min. If oxygenation was still inadequate chin lift and jaw thrust maneuver were performed and oropharyngeal airway was inserted.

次要结局

  • Heart rate(During surgery)
  • Arterial blood pressure(During surgery)
  • Symptomless Multi-Variable Apnea Prediction(sMVAP) index(up to 30 weeks)
  • Cigarette smoking(During surgery)
  • ASA status(During surgery)
  • Crystalloid infusion(During surgery)
  • Medications(During surgery)

研究者

发起方
University Hospital of Split
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivan Vuković, MD

Principal Investigator

University Hospital of Split

研究点 (1)

Loading locations...

相似试验