Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated Esophagogastroduodenoscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- procedural pain, measured using the visual analog scale (VAS).
研究概览
简要总结
This study aimed to compare the efficacy of lidocaine spray (S) alone versus lidocaine spray combined with lidocaine viscous solution (S+V) in facilitating pharyngeal observation during Non-sedating upper gastrointestinal endoscopy (UGE).
详细描述
A randomized controlled trial was conducted between July and October 2023 at Sawanpracharak hospital, Thailand. Of 250 patients undergoing UGE, 125 were randomly assigned to group S (lidocaine spray alone) and 125 to group S+V (lidocaine spray plus lidocaine viscous solution). The total dose of lidocaine did not exceed 5 mg/kg in both groups
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
- Single (Investigator)
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
- 否
入选标准
- •Patients scheduled for upper gastrointestinal endoscopy:
- •Patients who are robust, without chronic illnesses, or with controlled chronic conditions that do not adversely affect the function of any organ (American Society of Anesthesiologists (ASA) physical status classification I-II).
排除标准
- •Has a history of receiving painkillers or sleeping pills within 24 hours before the endoscopy.
- •Has a history of post-endoscopy nausea and vomiting.
- •Patients who have undergone upper gastrointestinal endoscopy previously.
- •Has chronic conditions such as epilepsy, vertigo, or mental health disorders.
- •Has a history of allergy to anesthesia used in the study.
- •Pregnant or currently breastfeeding.
- •Refuses to participate in the study.
研究组 & 干预措施
lidocaine spray alone
patient in this arm will receive lidocaine spray five puffs of 10 % lidocaine spray (Xylocaine 10 % Spray, Astra Zeneca) (1 puff = 10 mg of lidocaine) 5 minutes before the start of the procedure
干预措施: Lidocaine Spray (Drug)
receive lidocaine spray + lidocaine viscous solution
patient in this arm will receive lidocaine spray + lidocaine viscous solution five puffs of 10 % lidocaine spray (Xylocaine 10 % Spray, Astra Zeneca) (1 puff = 10 mg of lidocaine) Plus 5 mL of 2 % viscous lidocaine solution (20 mg/mL) (Xylocaine 2 %, Astra Zeneca, London, UK)
干预措施: Lidocaine Viscous+Lidocane spray (Drug)
结局指标
主要结局
procedural pain, measured using the visual analog scale (VAS).
时间窗: 30 minute after finished precedure
The procedural pain was evaluated using a visual analog scale (VAS, 0-10) with 0 being none and 10 being the most painfull
次要结局
- patient tolerance(immediately after finished precedure)
- endoscopist satisfaction(immediately after finished precedure)
- patient satisfaction(30 minute after finished precedure)
研究者
Natee Faknak
Clinical doctor at Department of medicine Sawanpracharak hospital
Sawanpracharak hospital