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临床试验/NCT05996588
NCT05996588已完成4 期

Comparison Between Inhalational Anesthetic (Sevoflurane) and Intravenous Anesthetic (Propofol Infusion) for Maintenance of Sedation During Endoscopic Retrograde Cholangiopancreatography

Sindh Institute of Urology and Transplantation1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2022年1月5日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
86
试验地点
1
主要终点
Mean arterial blood pressure

研究概览

简要总结

After approval of ethical committee of Sindh Institute of Urology & Transplantation (SIUT), 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Randomization was done by a computer-generated randomization table. Patients were divided in two groups based on agents used for the research study. Both the groups were induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group B propofol infusion at 50 ug/Kg/min started for maintenance of anaesthesia. Ketamine 0.5mg/kg intravenously was used to rescue the sedation level in both groups

详细描述

After approval of ethical committee of SIUT, 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Pre-operative assessment was done by history of patients, general physical examination, systematic examination, and laboratory investigations. Randomization was done by a computer-generated randomization table. Patients were divided in two groups based on agents used for the research study. Both the groups were induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group B propofol infusion at 50 ug/Kilogram/min started for maintenance of anaesthesia.

When Ramsay Sedation Scale 5 is achieved then the endoscopist was allowed to insert endoscope. Injection Ketamine 0.5 mg/kg body weight was used for rescue sedation level. Upon arrival in operation theatre standard monitoring which includes pulse oximeter (SPO2), noninvasive blood pressure (NIBP), electrocardiogram (ECG) electrodes were applied, and baseline readings will be recorded. After that venous access was secured on a non-dominant hand by 20 Gauge IV cannula. Ringer's lactate or normal saline was then started at 8 ml/kg/hour and O2 was given by nasal prongs at 4 L/min. All baseline parameters were taken, after that readings were taken at 5 min, 10 min, 15 min, 20 min and so on till procedure ends.

Complications such as respiratory depression, coughing, gagging, nausea and vomiting were recorded during the procedure and treated accordingly. If SpO2 went down below 92% for more than 10 seconds or patient developed apnea, it was considered oxygen desaturation.

Oxygen desaturation was managed by O2 inhalation and supporting airway. A heart rate under 40 beats per minute was considered bradycardia and it will be managed by inj Atropine 10 ug/Kilogram intravenously (I/V). Mean arterial pressures level that is lower than 60 mmHg or 20% less than the baseline was regarded as hypotension and it was managed by fluid bolus or vasopressors.

After the procedure, patients were awakened and shifted to recovery room. Complications such as respiratory depression, coughing, gagging, nausea and vomiting were recorded and treated accordingly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between age group of 20-60 years
  • Both male and female patients.
  • American Society of Anesthesiologist (ASA) physical status I-II
  • Elective ERCP procedure.

排除标准

  • Patients allergic to any study drug.
  • American Society of Anesthesiology (ASA) Physical status III-IV
  • Patients with uncontrolled Diabetes Mellitus,
  • Hypertension and renal insufficiency.
  • Body mass index (BMI) over 36 Kilogram/m2 (Morbid obesity)
  • Obstructive Sleep Apnea
  • Gastroesophageal reflux disease (GERD)
  • Pregnancy

研究组 & 干预措施

Propofol

Active Comparator

Propofol at a rate of 50 microgram/kg/min

干预措施: Propofol 1 % Injectable Suspension (Drug)

Sevoflurane

Experimental

Sevoflurane inhalation with oxygen via nasal prongs at a concentration 4-5% to achieve a MAC of 0.25

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Mean arterial blood pressure

时间窗: 0-2 hours

Mean arterial blood pressure via a non-invasive blood pressure monitor

Ramsay sedation score

时间窗: 0-2 hours

Clinical Score Patient's Characteristics 1. Awake; agitated or restless or both 2. Awake; cooperative, oriented, and tranquil 3. Awake but responds to commands only 4. Asleep; brisk response to light glabellar tap or loud auditory stimulus 5. Asleep; sluggish response to light glabellar tap or loud auditory stimulus 6. Asleep; no response to glabellar tap or loud auditory stimulus

Respiratory rate

时间窗: 0-2 hours

Respiratory rate via a vitals monitoring device

Oxygen saturation

时间窗: 0-2 hours

Oxygen saturation via a pulse oximeter

Heart rate

时间窗: 0-2 hours

Heart rate via vitals monitoring device

次要结局

未报告次要终点

研究者

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

Syed Muhammad Abbas

Associate Professor, Department of Anaesthesia

Sindh Institute of Urology and Transplantation

研究点 (1)

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