AANA developed policies and procedures that align with best available evidence for treating patients taking GLP-1 receptor agonists, which increase insulin synthesis and secretion, suppress glucagon secretion, reduce food intake through appetite suppression, slow gastric emptying, and promote beta-cell proliferation.

Considerations related to preoperative use of GLP-1 receptor agonists include withholding medication on the day of surgery/procedure in the case of a daily dose or the week before surgery in the case of a weekly dose. At this point, there are no changes to fasting guidelines. However, improvements in outcomes have been reported with changes such as a longer fasting period or clear-liquid diet for one to three days before surgery. Gastric point-of-care ultrasound (POCUS) should be considered to assess gastric contents and aspiration risks; the gastric antrum should be visualized when performing POCUS. Where gastric contents are present, a volumetric assessment should be performed to stratify aspiration risks. GLP-1 receptor agonists should be restarted after the procedure at the next scheduled dose.

“Open communication between patients and the surgical team is important with regard to recommendations for withholding GLP-1 agonist medications prior to surgery,” Micah Walden, D.N.P., a member of the AANA Practice Committee, said in a statement. “As providers, we take that information into account to perform an individualized, case-by-case assessment and create a care plan that will keep the patient safe and comfortable before, during, and after the procedure.”

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HealthDay News — The weight-loss drug Ozempic could be dangerous for a patient undergoing anesthesia, according to a new warning from the American Society of Anesthesiologists.

Semaglutide (Ozempic, Wegovy) and other drugs of this class (glucagon-like peptide-1 receptor agonists) cause digestion to slow down, which decreases hunger and reduces how much people eat. That food left in the stomach increases the risk for vomiting while under anesthesia, Michael Champeau, MD, president of the ASA, told HealthDay.

“We’ve had reports of people vomiting immediately preoperatively when there shouldn’t be any food in their stomach,” Champeau said. “As soon as we started hearing anecdotal reports and case reports, the mind immediately goes to how the drug works and what it does.”

The ASA is recommending that people on a GLP-1 receptor agonist like Ozempic stop taking it prior to surgery. If the drug is taken once a day, the daily dose should not be taken the morning of surgery, Champeau said. If the drug is taken once a week, the dose should be postponed until after surgery. For example, if the drug is usually taken every Sunday and surgery is scheduled for a Wednesday, patients should not take the Sunday dose. The drug needs to be stopped at least a week in advance of surgery. Patients can resume taking their GLP-1 receptor agonist the next day after surgery, Champeau said.

Those taking the drugs to control diabetes might need to briefly switch to another drug, he added. “They’re going to need to go to whichever doctor is managing their diabetes because they’re going to need to change to another antidiabetic therapy to keep their diabetes under control during those days that they’re not getting their Ozempic,” Champeau said.

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Exela Pharma Sciences is recalling 3 injectable products due to the potential presence of particulate matter. 

The recall was initiated following a routine inspection of samples in which silicone was identified as the particulate matter. Administering an injectable product with particulate matter could potentially result in local irritation or swelling, and in serious cases, may block blood vessels in vital organs.

The affected products include:

• 8.4% Sodium Bicarbonate Injection 50mEq/50mL (50mL single-dose vial)
  • Indicated for the treatment of metabolic acidosis. 
  • Packaged in a carton containing 20 vials (Exela brand) or 25 vials (Exela or Civica brand). 
  • Affected lot numbers include: P0001429 (expiration date 11/2023); P0001900 (expiration date 8/2024); P0001902 (expiration date 8/2024); P0001903 (expiration date 9/2024); P0001909 (expiration date 9/2024); P0001912 (expiration date 8/2024); P0001945 (expiration date 9/2024); P0002002 (expiration date 11/2024); and P0002052 (expiration date 12/2024).
  • Product was distributed between January 18, 2022 and February 15, 2023.

• Midazolam in 0.8% Sodium Chloride Injection 100mg/100mL
  • Indicated for sedation.
  • Packaged in 100mL vials labeled with Exela brand; 25 vials per corrugated shipper.
  • Affected lot number: 10001088 (expiration date 7/2024).
  • Product was distributed between July 14, 2023 and September 26, 2023.

• Elcys (cysteine hydrochloride Injection) 500mg/10mL
  • For nutritional requirements per total parenteral nutrition.
  • Packaged in 10mL vials with 10 vials per carton; vials are labeled with Exela brand.
  • Affected lot number: 10000798 (expiration date 3/2025).
  • Product was distributed between July 20, 2023 and August 1, 2023.

At this time, there have been no reports of adverse events related to this recall. Customers with questions can contact Exela at 828-341-6118 or email at recall@exela.us. 

Adverse events experienced with the use of these products should be reported to the Food and Drug Administration’s MedWatch program.

The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Exparel (bupivacaine liposome injectable suspension) to include both single-dose sciatic nerve block in the popliteal fossa as well as femoral nerve block in the adductor canal.

The sNDA is supported by data from 2 randomized, double-blind, active-controlled phase 3 studies (ClinicalTrials.gov Identifier: NCT05157841 [Study 1], NCT02713178 [Study 2]) that compared the efficacy and safety of Exparel to bupivacaine hydrochloride as a single-dose sciatic nerve block in the popliteal fossa for postsurgical regional analgesia in patients undergoing bunionectomy, and as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty.

Results from both studies showed that treatment with Exparel met the primary endpoint demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine hydrochloride. Moreover, Exparel was associated with a statistically significant reduction in postsurgical opioid consumption (key secondary endpoint) through 96 hours compared with bupivacaine hydrochloride.

“We believe these positive datasets provide the basis for broadening the Exparel label to include both sciatic and femoral nerve blocks, which represents the opportunity to manage pain with a single 10mL dose of Exparel for more than 3 million lower extremity procedures annually,” said Dave Stack, chief executive officer and chairman of Pacira BioSciences. “Importantly, this potential approval would give clinicians a safe and effective tool to provide 4 days of postsurgical pain control, reduce opioid requirements, and continue to migrate relevant orthopedic procedures to the outpatient setting.”

A Prescription Drug User Fee Act (PDUFA) action date of November 13, 2023 has been set for the application.

Exparel is currently approved in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

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HealthDay News — Initiating patient-controlled epidural anesthesia (PCEA) infusion in the operating room (OR) may improve pain control, according to a study presented at the annual American Society of Anesthesiologists Anesthesia Quality and Patient Safety Meeting, held virtually from July 14 to 15.

Murphy Owens, MD, from Weill Cornell Medicine in New York City, and colleagues examined the rate of intraoperative PCEA use and developed an improved workflow to start PCEA use in the OR. Charts were reviewed from December 2022 through February 2023 to examine PCEA connected to epidurals intraoperatively and by postanesthesia care unit (PACU) arrival. Postintervention feedback surveys on the new streamlined workflow were conducted with certified registered nurse anesthetists, residents, and attending anesthesiologists.

The researchers found that at the start of the project, very few epidural infusions were started in the OR, while at 2 months after the intervention, 90% were started in the OR. On survey of 16 anesthesiologists and 13 nurses regarding their experience with the new workflow, 56 and 79%, respectively, said patients were more comfortable when they arrived in the PACU; 56 and 79%, respectively, said patients required fewer intravenous or oral opioids; and 50 and 79%, respectively, said they were more satisfied with the new workflow.

“Effective pain management after surgery is a crucial issue in health care, and this streamlined approach for initiating epidural infusions in the OR reduces delays in the patient getting pain relief,” Owens said in a statement. “Additionally, research shows that using a PCEA can reduce patients’ need for opioids to manage their pain.”

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Paul N. Pfeiffer, MD, from the University of Michigan Medical School in Ann Arbor, and colleagues used data from the VA electronic medical records for 215 patients treated with IV ketamine infusions for depression in fiscal year 2020, with up to 12 months of follow-up.

The researchers found that participants had a mean of 2.1 antidepressant medication trials in the past year and 6.1 antidepressant trials in the 20 years prior to their first ketamine infusion. During the first 5 months of infusions, frequency of infusions decreased from every 5 days to every 3 to 4 weeks, with a mean of 18 total infusions over 12 months. After 6 weeks of treatment, 26% of participants had a response (50% improvement in the Patient Health Questionnaire-9 [PHQ-9] score) and 15% had remission (PHQ-9 score ≤5). At weeks 12 and 26, these improvements were similar. There were no associations between demographic characteristics and comorbid diagnoses with 6-week PHQ-9 scores.

“These findings ratchet down the hype about ketamine a bit, because we don’t see dramatic improvement after just one infusion, or strong response in most patients,” Pfeiffer said in a statement. “It’s not a silver bullet. But when we see these patients in our clinic, who have been through every treatment available and nothing has worked, to have even a quarter achieve a significant measurable response is very good.”

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