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临床试验/NCT06414395
NCT06414395招募中4 期

The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study

Theodor Bilharz Research Institute1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年5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
招募中
入组人数
52
试验地点
1
主要终点
• Recovery time of each group: the time from ending the infusions till a modified Aldrete score (MAS) score of ≥ 9 is reached.

研究概览

简要总结

Propofol is currently the most common drug used but has drawbacks like narrow therapeutic window and potential complications.

Dexmedetomidine is an attractive alternative due to its unique properties like minimal respiratory depression.

Studies are ongoing to find the optimal use of dexmedetomidine for these procedures. A combination of propofol and dexmedetomidine might be ideal, but the best balance between the two drugs needs further investigation.

详细描述

Advanced upper gastrointestinal tract procedures such as Endoscopic retrograde cholangiopancreatography (ERCP) & Endoscopic ultrasound (EUS) are very important diagnostic and therapeutic procedures for the diagnosis & management of many pancreatobiliary pathologies whether benign or malignant (1-4). These procedures require moderate-deep sedation with the patient lying in the lateral or semi-prone position to provide the operator easier access & insertion while permitting fluoroscopic visualisation (1-4).

Propofol sedation is currently the most popular drug used for advanced endoscopic procedures because of its shorter half-life which results in a shorter recovery time than conventional sedation (benzodiazepine &/or opioid) (5). Propofol was administered initially by intermittent boluses but later on was superseded by continuous infusion guided by clinical scoring, e.g., Ramsey sedation score (6), by target-controlled infusion (TCI) (7) or more recently by bispectral index (BIS) monitoring (8).

Propofol, however, has a narrow therapeutic window that may cause fluctuation of the level of sedation from moderately deep sedation to near general anesthesia. Not only that but also propofol sedation is associated with many other complications including apnoea, airway obstruction desaturation, hypotension, bradycardia, gagging, restlessness, regurgitation & vomiting & delayed recovery (9).

Dexmedetomidine, a highly specific, potent and selective α2-adrenoceptor agonist, was originally introduced as a sedative for critically ill mechanically ventilated patients [9]. In addition to sedation, it has a group of unique properties in the form of analgesia, reduction of sympathetic tone and attenuation of the neuroendocrine and hemodynamic responses to anesthesia and surgery with minimal respiratory depression, making it an attractive agent for perioperative sedation especially in remote areas outside the operating theatres (6,10).

The quest to replace propofol coupled with the unique sedo-analgesic properties of dexmedetomidine resulted in the interest in the use of dexmedetomidine for providing sedation for advanced endoscopic procedure (6,10).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Randomization will be performed using computer generated numbers with Random Allocation Software in a 1:1:1:1 ratio. The patient's allocation and drug administration instructions will be kept in consequentially numbered opaque envelopes (equal number per each group). A colleague, not participating to the study, will be responsible for study drugs preparation & labelling.

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

  • Patients aged 18-65
  • Both sexes

排除标准

  • Patients' refusal to participate
  • ASA III-IV
  • BMI > 35
  • Patients who are considered high aspiration risk, e.g., gastric outlet obstruction
  • Allergy to any medications used
  • Diabetics
  • Any patient receiving cardioactive drugs, e.g., Beta blockers, Calcium channel blockers, Inhaled B2 bronchodilators)
  • Patients with Pacemakers or heart rate below 50 beat/min
  • Pregnant women
  • Habitual Drug abusers
  • Patients who had to be intubated during the procedure.

研究组 & 干预措施

The Dexmedetomidine Group D1

Experimental

D1 group will receive 1µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg.

干预措施: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection (Drug)

The Dexmedetomidine Group D 0.5

Experimental

D 0.5 group will receive 0.5 µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg

干预措施: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection (Drug)

The Dexmedetomidine Group D0.25

Experimental

D 0.25 group will receive 0.25 µg.kg as a loading dose over 10 minutes, followed by maintenance 0.5 µg.kg

干预措施: Precedex (Dexmedetomidine) 200 MCG in 2 ML Injection (Drug)

结局指标

主要结局

• Recovery time of each group: the time from ending the infusions till a modified Aldrete score (MAS) score of ≥ 9 is reached.

时间窗: 4 months

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

Sameh Mohamed Elaidy

Assistant lecturer

Theodor Bilharz Research Institute

研究点 (1)

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