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Front Med (Lausanne). 2016 Feb 02;3:1. doi: 10.3389/fmed.2016.00001. eCollection 2016.

The Effect of a Combination Treatment Using Palonosetron, Promethazine, and Dexamethasone on the Prophylaxis of Postoperative Nausea and Vomiting and QTc Interval Duration in Patients Undergoing Craniotomy under General Anesthesia: A Pilot Study.

Frontiers in medicine

Sergio D Bergese, Erika G Puente, Maria A Antor, Gerardo Capo, Vedat O Yildiz, Alberto A Uribe

Affiliations

  1. Department of Anesthesiology, The Ohio State University Medical Center, Columbus, OH, USA; Department of Neurological Surgery, The Ohio State University Medical Center, Columbus, OH, USA.
  2. Department of Anesthesiology, The Ohio State University Medical Center , Columbus, OH , USA.
  3. Department of Anesthesiology, Jackson Memorial Hospital, University of Miami , Miami, FL , USA.
  4. College of Arts and Sciences, The Ohio State University , Columbus, OH , USA.
  5. Center for Biostatistics, The Ohio State University , Columbus, OH , USA.

PMID: 26870733 PMCID: PMC4735400 DOI: 10.3389/fmed.2016.00001

Abstract

INTRODUCTION: Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 h after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone, and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia.

METHODS: The research protocol was approved by the institutional review board and 40 subjects were provided written informed consent. At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV, and promethazine 25 mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit or post anesthesia care unit as clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24 h for 5 days via direct interview and/or medical charts review.

RESULTS: The overall incidence of PONV during the first 24 h after surgery was 30% (n = 12). The incidence of nausea and emesis 24 h after surgery was 30% (n = 12) and 7.5% (n = 3), respectively. The mean time to first emetic episode, first rescue, and first significant nausea was 31.3 (±33.6), 15.1 (±25.8), and 21.1 (±25.4) hours, respectively. The overall incidence of nausea and vomiting after 24-120 h period after surgery was 30% (n = 12). The percentage of subjects without emesis episodes over 24-120 h postoperatively was 70% (n = 28). No subjects presented a prolonged QTc interval ≥500 ms before and/or after surgery.

CONCLUSION: Our data demonstrated that this triple therapy regimen may be an adequate alternative regimen for the treatment of PONV in patients undergoing neurological surgery under general anesthesia. More studies with a control group should be performed to demonstrate the efficacy of this regimen and that palonosetron is a low risk for QTc prolongation.

CLINICALTRIALSGOV IDENTIFIER: NCT02635828 (https://clinicaltrials.gov/show/NCT02635828).

Keywords: QTc; emesis; nausea; postoperative complications; vomiting

References

  1. J Neurosurg. 2011 Feb;114(2):491-6 - PubMed
  2. Front Med (Lausanne). 2015 Jun 15;2:40 - PubMed
  3. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):76-83 - PubMed
  4. Korean J Anesthesiol. 2014 Apr;66(4):327-8 - PubMed
  5. Drugs. 2013 Sep;73(14):1525-47 - PubMed
  6. BMC Pharmacol Toxicol. 2015 Jan 26;16:1 - PubMed
  7. J Perianesth Nurs. 2015 Feb;30(1):5-13 - PubMed
  8. Ther Clin Risk Manag. 2009 Feb;5(1):21-34 - PubMed
  9. Ther Clin Risk Manag. 2015 May 05;11:713-29 - PubMed
  10. Cancer Manag Res. 2012;4:67-73 - PubMed
  11. Curr Ther Res Clin Exp. 2005 Sep;66(5):409-19 - PubMed
  12. Support Care Cancer. 2016 Feb;24(2):621-7 - PubMed
  13. Ann Palliat Med. 2012 Jul;1(2):94-102 - PubMed
  14. J Am Coll Cardiol. 2010 Mar 2;55(9):934-47 - PubMed
  15. Br J Anaesth. 2014 Mar;112(3):485-90 - PubMed
  16. Br J Anaesth. 2012 Nov;109(5):742-53 - PubMed
  17. Korean J Anesthesiol. 2015 Jun;68(3):267-73 - PubMed
  18. Can J Anaesth. 2003 Aug-Sep;50(7):749-50 - PubMed
  19. Anesth Essays Res. 2014 May-Aug;8(2):197-201 - PubMed
  20. Korean J Anesthesiol. 2012 Oct;63(4):334-9 - PubMed
  21. Anesth Analg. 2014 Jan;118(1):85-113 - PubMed
  22. Drugs. 2000 Feb;59(2):213-43 - PubMed
  23. Br J Anaesth. 2002 Sep;89(3):409-23 - PubMed
  24. Br J Clin Pharmacol. 2013 Jul;76(1):48-57 - PubMed
  25. Korean J Anesthesiol. 2013 Nov;65(5):397-402 - PubMed
  26. Korean J Anesthesiol. 2014 Aug;67(2):110-4 - PubMed
  27. Expert Opin Pharmacother. 2015 May;16(7):1069-77 - PubMed

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