Getting Started
As a prescriber, you will be bombarded with information about new medications and may even feel pressure to prescribe them. This information and pressure may come from drug reps, journal advertisements, and even patients. The journal club/article review is meant to help you learn to make your own judgments regarding the importance of a new medication (or new indication).
Upon successful completion of the course material, you will be able to:
Take a primary research study and make an informed decision regarding the significance of the study.
Apply study results to practice.
Resources
Textbook: Pharmacotherapeutics for Advanced Practice Providers
Lexi-Comp (available via Up-to-Date) or other suitable drug/disease reference.
Suggested treatment guidelines/recommendations for this workshop
Chosen article and any other necessary references
Instructions
Review the rubric to make sure you understand the criteria for earning your grade.
Chose an article of interest to you from one of your professional journals and critique it. As indicated in the syllabus, the desired article is one of the primary research. It should involve statistical analysis of a pharmaceutical agent that is being compared to another medication or a placebo. The article can pertain to a new medication, or a new indication for an existing medication but it must be studied in subjects requiring treatment, not healthy volunteers.
Include at least the following in your analysis of the article (see example here):
Title of the article (including journal reference)
Study objective(s)
Study design
Overall design
Study endpoints (primary, secondary, etc.)
Inclusion/exclusion criteria
Subject baseline characteristics
Results
Efficacy and safety outcomes, if applicable
Statistical significance (p-values, confidence intervals, etc. as applicable)
Personal conclusions
Personal thoughts on the study
Impact to practice
How might the study change the way we practice?
The article review should be written using APA style.
When you have completed your assignment, save a copy for yourself and submit a copy to your faculty by day seven of the workshop (Turnitin enabled).
Access the associated rubric
Access the Assignment submission page
Journal of Anesthesia (2018) 32:748–755 https://doi.org/10.1007/s00540-018-2549-x
Use of propofol for prevention of post-delivery nausea during cesarean section: a double-blind, randomized, placebocontrolled trial
Kun Niu1,2 · Hui Liu2 · Ruo‑Wen Chen2 · Qi‑Wu Fang2 · Hui Wen2 · Su‑Mei Guo3 · John P. Williams4 · Jian‑Xiong An1,2
Received: 30 December 2017 / Accepted: 8 September 2018 / Published online: 12 September 2018
© The Author(s) 2018
Abstract
Purpose Nausea and vomiting are common, undesirable symptoms during cesarean section. We conducted this study to assess the antiemetic properties of propofol for the prevention and immediate treatment of post-delivery nausea and vomiting during cesarean section under combined spinal–epidural anesthesia.
Methods Eighty women undergoing elective cesarean delivery under combined spinal–epidural anesthesia were randomized to receive either propofol at a plasma concentration of 1000 ng/mL or normal saline immediately after clamping of the umbilical cord. The incidence of post-delivery nausea and vomiting, patients requiring rescue antiemetic, bispectral index, sedation score, and the incidence of hypotension were assessed intraoperatively. Satisfaction and neonatal behavioral neurological assessments were evaluated postoperatively.
Results The incidence of nausea was significantly lower in the propofol group compared to the placebo group (25% versus 60%, P < 0.001). The incidence of retching and vomiting showed no significant difference between the two groups. Propofol 20 mg as a rescue antiemetic was significantly effective in both the groups. Satisfaction level of patients and obstetricians in the propofol group was higher than in the placebo group. There was no statistical difference in the incidence of hypotension between the two groups both pre- and post-delivery. There was no difference in postoperative neonatal behavioral neurological assessment between groups.
Conclusion Propofol at a plasma concentration of 1000 ng/mL significantly reduced the incidence of post-delivery nausea compared to placebo, but had no effect on reducing retching or vomiting episodes during cesarean section.
Keywords Cesarean section · Propofol · Post-delivery · Nausea and vomiting
750 Journal of Anesthesia (2018) 32:748–755
Journal of Anesthesia (2018) 32:748–755 749
1 3
1 3
Kun Niu and Hui Liu contributed equally to this work.
* Jian-Xiong An anjianxiong@yahoo.com
1 Department of Anesthesiology, Weifang Medical University, Weifang City 261000, Shandong, China
2 Department of Anesthesiology, Pain Medicine and Critical Care Medicine, Aviation General Hospital of China
Medical University and Beijing Institute of Translational
Medicine, Chinese Academy of Sciences, Beiyuan Rd 3#,
Beijing 100012, China
3 Department of Pediatrics, Aviation General Hospital of China Medical University and Beijing Institute of Translational Medicine, Chinese Academy of Sciences, Beijing 100012, China
4 Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburg, PA 15213, USA
Vol:.(1234567890)1 3
Introduction
Intraoperative nausea and vomiting (IONV) are among the common undesirable symptoms in women undergoing spinal anesthesia for cesarean section [1, 2]. Besides causing patient discomfort, it interferes with surgery and increases procedure time, risk of bleeding, inadvertent surgical trauma, and risk of pulmonary aspiration of gastric contents [3].
In view of such high incidence of intraoperative postdelivery nausea and vomiting, several studies have made an effort to design both medication and non-medication therapies [1, 4–9], such as ondansetron, metoclopramide, droperidol, ginger, acupressure and acupuncture. Although these treatments have been proved to reduce the incidence of nausea and vomiting, many of these drugs were standard treatment for postoperative nausea and vomiting (PONV) rather reluctantly for parturient [2]. Ideally, one would prefer a more comfortable, safe and effective prophylaxis and immediate treatment of IONV occurrence for parturient.
Previous studies have confirmed that a bolus dose or a continuous infusion of propofol has direct antiemetic properties [2, 3, 10]. In addition, only a few clinical trials have demonstrated that infusion of propofol at a low dose (1.0 mg/kg/h) is effective in prevention of nausea and vomiting during and after cesarean section [11–13]. However, they did not provide the treatment details about parturient, who had experienced immediate nausea and vomiting, or evaluated the neonatal behavior associated with postoperative breastfeeding. We hypothesized that a continuous infusion of propofol, along with bolus doses for immediate control, might be effective and safe to decrease the incidence of IONV compared to placebo in parturients undergoing cesarean section.
Methods
The study was conducted according to the Ethical Principles for Medical Research Involving Human Subjects outlined in the Declaration of Helsinki. This work was approved by the Ethical Committee of Aviation General Hospital (HK20161011) and registered at http://www.chict r.org. cn/index .aspx (ChiCTR-INR-16009539). All participants signed an informed consent form. Parturients with a singleton pregnancy, ASA physical status I or II, and receiving combined spinal–epidural anesthesia for elective cesarean section were included. We excluded patients with severe cardiac disease; insulin-dependent diabetes mellitus; severe impairment of hepatic or renal function; contraindications to regional anesthesia; history of allergic reactions to propofol or ondansetron; and those who had an antiemetic drug administered within 24 h prior to anesthesia. This singlecenter trial was conducted between October 2016 and February 2017 at Aviation General Hospital, Beijing, China. This manuscript adheres to the CONSORT guidelines.
Patients were randomly allocated by a random number generator system by research fellow A in a 1:1 allocation ratio to receive either normal saline (placebo group) or propofol (propofol group). Both patients and the anesthesiologists were blinded to randomization. Equal volumes of both 1% propofol (10 mg/mL, Xi’an Libang Pharmaceutical& Co., Ltd; Xi’an, Shaanxi Province, China) and 0.9% normal saline were drawn in a 20-mL syringe by research fellow A. The exterior color of each syringe was similar and indistinguishable by using a wrapped paper and the treatment was masked with opaque infusion lines. The parturient head site was covered by surgical drapes during the operation so they could not see the infusion line. After obtaining consent, patients were allocated to either the propofol or the placebo group by opening a sealed opaque envelope. Before the administration of anesthesia, research fellow B instructed each patient to report if they felt nausea at any time during the surgery.
All patients were administered 500–1000 mL of Lactated Ringer’s solution prior to the commencement of anesthesia. Standard monitoring included ECG, non-invasive blood pressure (BP), and pulse oximetry. Data on monitored parameters were collected by research fellow B. We used a combined spinal–epidural (CSE) anesthesia technique across the study groups: patients were placed in either the right or left lateral decubitus position, and skin infiltration with 2% lidocaine was carried out at the L2–L3 or L3–L4 interspace. A 16-gauge 80.00-mm AN-E epidural needle (Round-smooth; Tuoren Medical Device & Co., Ltd; Xinxiang, Henan Province, China) was inserted into…
