scholarly journals Olanzapine for the Prevention and Treatment of Nausea and Vomiting Induced by Chemotherapy for Lung Cancer: protocol for a multicenter, double-blind and randomized controlled trial

2019 ◽  
Author(s):  
Jian-Guo Zhou ◽  
Pei-Jie Li ◽  
Su-Han Jin ◽  
Da-Hai Liu ◽  
Lang Huang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Randomized Controlled Trial ◽  
Receptor Antagonist ◽  
Controlled Trial ◽  
Nausea And Vomiting ◽  
Effective Control ◽  
List Type ◽  
Double Blind ◽  
Randomized Controlled ◽  
Delayed Cinv

AbstractBackgroundChemotherapy-induced nausea and vomiting (CINV) is frequently observed after the administration of chemotherapy and significantly influences the quality of life (QoL) of patients. Olanzapine has a high control rate of CINV in patients with cancer when combined with the NK-1 receptor antagonist dexamethasone and 5-hydroxytryptamine (5-HT3) receptor antagonists. The efficacy of a regimen without an NK-1 receptor antagonist remains unknown. Therefore, we designed this randomized trial to provide evidence for the management of CINV.Methods and ananlysisThis is a double-blind, multicenter and randomized controlled trial. Patients with histologically confirmed lung cancer will be assessed by physicians based on the inclusion and exclusion criteria, and 156 participants will be enrolled and randomized to a placebo group or experiment group to receive treatment for CINV. The primary endpoint is the incidence of delayed CINV. The secondary endpoints are complete response (CR) of acute CINV, CR of delayed CINV, effective control rate (ECR) of CINV and QoL. During the six days after administration, these endpoints will be evaluated and recorded by physicians.Ethic and disseminationThis study has received approval from the institutional ethical review board of the Affiliated Hospital of Zunyi Medical University (ref approval No. 58). Written informed consent will be signed by all participants prior to enrolling. Participants will be randomly assigned to the experimental group or comparator group by blocked randomization.Article summaryStrengths and limitationsThis study will provide evidence for physicians to find an affordable and effective treatment regimen for CINV through this study.Because of the variety of pharmaceutical companies, medical care and other factors, problem of cost will be further explored in the following studies.Although the study is designed as a double-blind randomized controlled trial, QoL will be measured by a questionnaire that is filled out by patients themselves. This may influence the conclusions.

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.

scholarly journals Adding dexmedetomidine to morphine-based analgesia reduces early postoperative nausea in patients undergoing gynecological laparoscopic surgery: A randomized controlled trial

2019 ◽  
Author(s):  
Huai Jin Li ◽  
Shan Liu ◽  
Zhiyu Geng ◽  
Xue Ying Li
Keyword(s):  
Randomized Controlled Trial ◽  
Laparoscopic Surgery ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Double Blind ◽  
Randomized Controlled ◽  
First Onset ◽  
Lockout Interval

Abstract Purpose: Few studies have investigated the effect of dexmedetomidine on postoperative nausea and vomiting (PONV) in patients following gynecological laparoscopic surgery. We investigated if adding dexmedetomidine to a morphine-based patient-controlled analgesia (PCA) could reduce the incidence of PONV in this patient population. Methods: In this double-blind randomized-controlled trial,122 patients undergoing gynaecological laparoscopic surgery were randomly allocated to receive either a mixture of dexmedetomidine 1μg ml-1 and morphine 0.5mg ml-1 (Group Dex) or morphine 0.5mg ml-1 alone (Group Ctrl) for postoperative i.v. PCA. PCA pump was programmed as followed: bolus dose 2ml, lockout interval 8 minutes and background infusion at a rate of 1ml h-1. The primary outcome was the incidence of nausea and vomiting within 24 hours after operation. Results: The incidence of nausea and total PONV during the first 2h period was significantly lower in the Group Dex than in the Group Ctrl (10% vs 25%, P=0.031 and 0.031, respectively). There were no significant differences in regard to the total incidence of PONV (41% vs 52%, P=0.204), PONV score, time to first onset of PONV, or the need for rescue antiemetics in the first 24 hr following surgery between the two groups. Conclusions: For female patients undergoing gynecological laparoscopic surgery, adding dexmedetomidine to morphine-based PCA reduced the incidence of early postoperative nausea but not total PONV within 24h after surgery.

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