Acupuncture for Relief of Gag Reflex in Patients Undergoing Transesophageal Echocardiography - a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of gagging during probe insertion
研究概览
简要总结
The aim of the study is to test whether stimulation of acupuncture points CV24 and P6 is better than placebo acupuncture in treatment of gagging in patients undergoing elective transesophageal echocardiography (TEE)
详细描述
Patients undergoing elective transesophageal echocardiography (TEE) often report discomfort because of active gagging reflex, which sometimes preclude the performance of TEE and requires additional medication. According to existing literature, needling of acupoint CV24 effectively prevents gagging during dental procedures. We are going to use this phenomenon in patients scheduled to TEE in order to reduce discomfort during insertion of TEE probe and reduce the need for additional sedative medication. Within this investigation the patients will be randomly assigned to receive either verum acupuncture of CV24 and P6 acupoints or placebo procedure immediately before TEE examination. As outcome the incidence and intensity of gagging, total dose of additional sedative medication and hemodynamic parameters will be recorded.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective ambulatory transesophageal echocardiography (TEE) without sedation
- •TEE time does not exceed 30 minutes
- •Patients without previous opioid and psychotropic medication
- •Patients aged between 30 and 65 years, able to use visual analogue scale 100 mm
- •Patients who have given written informed consent
排除标准
- •Current psychiatric disease
- •Local skin infection at the sites of acupuncture
- •Aged < 30 or > 65 years
- •TEE time more than 30 min
- •Patients who consumed opioid medication at least 6 months before surgery
- •Patients with the history of: i) psychiatric disease; ii) insulin-dependent diabetes mellitus; iii) radio- or chemotherapy; iv) peripheral polyneuropathy.
- •Patients who are unable to understand the consent form or to use visual analogue scale 100 mm
研究组 & 干预措施
Acupuncture
Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure
干预措施: Acupuncture (Procedure)
Control
Application of Placebo needles in the areas of P6 and CV24 acupoints
干预措施: Placebo (Procedure)
结局指标
主要结局
Incidence of gagging during probe insertion
时间窗: 10 minutes after TEE probe insertion
Incidence of gagging during TEE probe insertion: yes=1; no=2
次要结局
- Gagging score(10 minutes after TEE probe insertion)
- Rescue medication(10 minutes after TEE probe insertion)