scholarly journals The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Huiqing Xu ◽  
Xu Wei ◽  
Ranxing Zhang ◽  
Ling Li ◽  
Zhijun Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
General Anesthesia ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Randomized Controlled ◽  
Link Type ◽  
Prevention And Treatment

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.

scholarly journals The Effect of a Transdermal Scopolamine Patch on Postoperative Nausea and Vomiting after Retromastoid Craniectomy with Microvascular Decompression: A Preliminary Single Center, Double-Blind, Randomized Controlled Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 156 ◽  
Author(s):  
Hyun Hee Lee ◽  
Hyun-Mi Kim ◽  
Ji Eun Lee ◽  
Young-Tae Jeon ◽  
Sanghon Park ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Microvascular Decompression ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Mean

Background: We performed this prospective double-blind randomized controlled trial to identify the effect of a preoperative prophylactic transdermal scopolamine (TDS) patch on postoperative nausea and vomiting (PONV) after retromastoid craniectomy with microvascular decompression (RMC-MVD). Methods: We recruited 38 patients undergoing RMC-MVD and randomized them into two groups: the TDS group (n = 19, application of the TDS patch) and placebo group (n = 19, application of a sham patch). Nausea (as a self-reported 100-mm visual analog scale (VAS) score; range, 0 (no nausea) to 10 (worst nausea)), vomiting, and the use of antiemetics were the primary endpoints. Results: There was no significant difference in terms of the incidence of PONV (73.7% in the TDS group and 78.9% in the placebo group; p = 1.00) between the groups. However, the mean nausea VAS score was significantly different at arrival to the general ward (0.93 ± 1.71 in the TDS group vs. 2.52 ± 2.85 in the placebo group; p = 0.046), and throughout the study period (0.03 ± 0.07 in the TDS group vs. 0.44 ± 0.71 in the placebo group; p = 0.029). Rescue antiemetics were more frequently used in the placebo group than in the TDS group (9 (47.4%) vs. 2 (10.5%), respectively; p = 0.029). The mean number of antiemetics used throughout the study period was significantly higher in the placebo group than in the TDS group (1.37 ± 2.19 vs. 0.16 ± 0.50, respectively; p = 0.029). Conclusions: The preoperative prophylactic use of a TDS patch was safe and effective in the management of PONV after RMC-MVD in terms of the severity of PONV and the use of rescue antiemetics.

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