Huiqing Xu1, Xu Wei2, Ranxing Zhang3, Ling Li1, Zhijun Zhang1, Ruo Jia1, Xiaofei Zhang1, Xiumei Gao4, Xicheng Dong5, Junjun Pan6. 1. Department of Anesthesiology, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. 2. Department of Scientific Research, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. 3. Department of Clinical Laboratory, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. 4. Department of Anesthesiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. 5. Department of Anesthesiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. 6. TCM Characteristic Clinical Center, Wangjing Hospital, China Academy of Chinese Medical Sciences, 100102, Beijing, China. jojopan128@163.com.
Abstract
BACKGROUND:Postoperative nausea and vomiting (PONV) are common in posterior lumbar intervertebral fusion (PLIF) patients undergoing general anesthesia. The previous clinical observation has shown that a traditional acupoint herbal plaster (AHP) is beneficial to patients with PONV. This trial aims to assess the effect of the AHP for the prevention and treatment of PONV after PLIF in patients with general anesthesia. METHODS: A multicenter, parallel, randomized controlled trial (RCT) will be conducted. A total of 166 participants will be randomized to either a treatment group receiving an AHP or a control groups receiving an acupoint placebo plaster (APP) in a 1:1 ratio. The primary outcomes are the first occurrence and frequency of nausea and vomiting. The secondary outcomes include the severity grading of nausea and vomiting using a visual analog scale (VAS) measurement system, quality of life, and serological indicators. The safety evaluation is mainly about adverse events and skin reactions' observation. Assessments will be carried out at the baseline, day 1, and day 2 (the end of the intervention). The central randomization system in the clinical trial ( http://124.205.181.142:8082/xwtf/ ) will be used to conduct random allocation. DISCUSSION: This scientific methodology design of the trial is expected to provide clinical evidence to support the AHP for the prevention and treatment of PONV. TRIAL REGISTRATION: This study is retrospectively registered with the Chinese Clinical Trial Registry ( http://www.chictr.org.cn ) on 19 April 2018. ID: ChiCTR1800015768.
RCT Entities:
BACKGROUND:Postoperative nausea and vomiting (PONV) are common in posterior lumbar intervertebral fusion (PLIF) patients undergoing general anesthesia. The previous clinical observation has shown that a traditional acupoint herbal plaster (AHP) is beneficial to patients with PONV. This trial aims to assess the effect of the AHP for the prevention and treatment of PONV after PLIF in patients with general anesthesia. METHODS: A multicenter, parallel, randomized controlled trial (RCT) will be conducted. A total of 166 participants will be randomized to either a treatment group receiving an AHP or a control groups receiving an acupoint placebo plaster (APP) in a 1:1 ratio. The primary outcomes are the first occurrence and frequency of nausea and vomiting. The secondary outcomes include the severity grading of nausea and vomiting using a visual analog scale (VAS) measurement system, quality of life, and serological indicators. The safety evaluation is mainly about adverse events and skin reactions' observation. Assessments will be carried out at the baseline, day 1, and day 2 (the end of the intervention). The central randomization system in the clinical trial ( http://124.205.181.142:8082/xwtf/ ) will be used to conduct random allocation. DISCUSSION: This scientific methodology design of the trial is expected to provide clinical evidence to support the AHP for the prevention and treatment of PONV. TRIAL REGISTRATION: This study is retrospectively registered with the Chinese Clinical Trial Registry ( http://www.chictr.org.cn ) on 19 April 2018. ID: ChiCTR1800015768.
Entities:
Keywords:
Acupoint herbal plaster; Chinese medicine; Postoperative nausea and vomiting; Randomized controlled trial