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临床试验/NCT06378879
NCT06378879尚未招募不适用

Intermittent Boluses Versus Continuous Infusion of Propofol During Standard Upper Endoscopy

Al-Balqa Applied University0 个研究点目标入组 100 人开始时间: 2024年9月6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
尚未招募
入组人数
100
主要终点
Sedation induction time (minutes)

研究概览

简要总结

It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events.

详细描述

Patients of both genders, aged between 18 and 85 years old and referred to standard upper endoscopy at Luzmila Hospital will be included in the study. Patients who are pregnant, have known allergies to the drugs used or a history of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension) or gastrectomy, are American Society of Anesthesiologist (ASA) class ≥ IV (11), or are unable to provide informed consent will be excluded from participating in the study. The patients undergoing a standard upper endoscopy will be randomly assigned to either continuous infusion (CI group) of propofol (Diprivan) with induction using benzodiazepine (2 mg Dormicum i.v.) or only intermittent bolus injection (BI group) of propofol (Diprivan) infused by an anesthesiologist. BI was defined by intermittent use of 20 mg propofol (Diprivan) boluses on demand, with a minimum period of 30 seconds between boluses to evaluate the effect of the drug. CI was defined by continuous propofol (Diprivan) infusion at a 3 mg/ kg/h rate.

The anesthesiologist will follow up the patient during the first observation period, the average time spent in the recovery area and register the requied data during the procedure using Aldrete score (a post anesthesia recovery score where a minimum score of 8 is required for discharge).

The patients' identities will be coded and the data will be kept confidential. The study protocol will be performed according to the Decalrations of Helsinki and will be applied for approval by the Institutional Review Board at Al-Balqa Applied University. Written informed consent was obtained from all patients.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both genders
  • Age between 18 and 85 years old
  • Referred to standard upper endoscopy at Luzmila Hospital

排除标准

  • Patients who are pregnant,
  • Known allergies to the used drugs
  • History of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension)
  • Previous history of gastrectomy,
  • Patients are American Society of Anesthesiologist (ASA) class ≥ IV ,
  • Patients are unable to provide informed consent

研究组 & 干预措施

Continuous infusion (CI group) of propofol

Active Comparator

CI was defined by continuous propofol infusion at a 3 mg/ kg/h rate with induction using benzodiazepine (2 mg dormicum i.v.) to evaluate the effect of the drug and assess sedation induction time, total dose of propofol, recovery time, quality of sedation.

干预措施: Propofol 100 MG in 10 ML Injection (Drug)

Intermittent bolus injection (BI group) of propofol

Active Comparator

BI was defined by intermittent use of 20 mg propofol boluses on demand, with a minimum period of 30 seconds between boluses to evaluate the effect of the drug and assess sedation induction time, total dose of propofol, recovery time, quality of sedation.

干预措施: Propofol 100 MG in 10 ML Injection (Drug)

结局指标

主要结局

Sedation induction time (minutes)

时间窗: 30 minutes

Sedation induction time (minutes) is the time measured from the deep sedation induction until the patient is deeply sedated

Total dose of propofol (mg)

时间窗: 30 minutes

Total dose of propofol (mg) used during the upper endoscopy procedure

Recovery time (minutes)

时间窗: 30 minutes

Recovery time (minutes) is the time used for the patients to open their eyes after stoping sedation

次要结局

  • Involuntary movement(30 minutes)
  • Adverse events(30 minutes)
  • Quality of sedation(30 minutes)

研究者

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

Tarek Mazzawi

Assistant Professor

Al-Balqa Applied University

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