Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery

NCT01592708 | Completed Results

• 2 other identifiers: 12-0622R01DE005215
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a multi-modal anesthesia and pain control protocol reduces post-operative and post-discharge nausea and vomiting (PONV and PDNV) in patients undergoing upper jaw corrective surgery.

Conditions

Post-operative Nausea; Post-operative Vomiting; Nausea Persistent

Keywords

orthognathic surgery; maxillary osteotomy; post operative nausea vomiting; post discharge nausea vomiting; anesthesia

Outcome Measures

Primary Outcomes (2)

• Post-operative Nausea

  End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted.

  End of surgery to discharge from hospital

• Post-operative Vomiting

  End of surgery to discharge from hospital

Secondary Outcomes (3)

• Hospital Length of Stay

  Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours

• Post-discharge Nausea

  1 week from discharge from hospital

• Post-discharge Vomiting

  1 week post discharge

Study Arms (1)

Antiemetic anesthesia protocol

ACTIVE COMPARATOR

Scopolamine 1.5 milligram(mg) patch Propofol infusion remifentanil infusion 250mg erythromycin po for 2 doses Solumedrol 0.625mg IV droperidol 4mg IV Ondansetron Ketorolac 30mg IV ibuprofen 600mg po q6h Fentanyl Hydrocodone/Tylenol po

Other: Antiemetic anesthesia protocol

Interventions

Antiemetic anesthesia protocol OTHER

Intervention group consisted of patients undergoing maxillary osteotomy who received an antiemetic protocol designed to provide multimodal antiemetic therapy which have been shown to help prevent and/or treat postoperative nausea, combined with the elimination of anesthetic factors that may contribute to postoperative nausea and vomiting.

Also known as: Scopolamine 1.5 milligram(mg) patch, Propofol infusion, remifentanil infusion, 250mg erythromycin po for 2 doses, Solumedrol, 0.625mg IV droperidol, 4mg IV Ondansetron, Ketorolac 30mg IV, ibuprofen 600mg po q6h, Fentanyl, Hydrocodone/Tylenol po

Antiemetic anesthesia protocol

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Undergoing elective orthognathic surgery involving a maxillary osteotomy

You may not qualify if:

• uncontrolled GERD or hiatal hernia
• glaucoma
• seizure disorder
• COPD
• obstructive sleep apnea
• chronic kidney disease stage III or greater
• known prolonged QT interval (QTc \> 460) or the same found incidentally
• history of severe constipation
• pre-existing chronic nausea or vomiting
• allergies or contraindications to protocol medications
• patient insistence on inhalational induction of anesthesia.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

UNC-Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (29)

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• Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

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• Fero KE, Jalota L, Hornuss C, Apfel CC. Pharmacologic management of postoperative nausea and vomiting. Expert Opin Pharmacother. 2011 Oct;12(15):2283-96. doi: 10.1517/14656566.2011.598856. Epub 2011 Jul 15.

  PMID: 21756206 BACKGROUND

• Gan TJ, Meyer TA, Apfel CC, Chung F, Davis PJ, Habib AS, Hooper VD, Kovac AL, Kranke P, Myles P, Philip BK, Samsa G, Sessler DI, Temo J, Tramer MR, Vander Kolk C, Watcha M; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2007 Dec;105(6):1615-28, table of contents. doi: 10.1213/01.ane.0000295230.55439.f4.

  PMID: 18042859 BACKGROUND

• Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.

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• Tramer MR, Fuchs-Buder T. Omitting antagonism of neuromuscular block: effect on postoperative nausea and vomiting and risk of residual paralysis. A systematic review. Br J Anaesth. 1999 Mar;82(3):379-86. doi: 10.1093/bja/82.3.379.

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• Kranke P, Morin AM, Roewer N, Wulf H, Eberhart LH. The efficacy and safety of transdermal scopolamine for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2002 Jul;95(1):133-43, table of contents. doi: 10.1097/00000539-200207000-00024.

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• Apfel CC, Zhang K, George E, Shi S, Jalota L, Hornuss C, Fero KE, Heidrich F, Pergolizzi JV, Cakmakkaya OS, Kranke P. Transdermal scopolamine for the prevention of postoperative nausea and vomiting: a systematic review and meta-analysis. Clin Ther. 2010 Nov;32(12):1987-2002. doi: 10.1016/j.clinthera.2010.11.014.

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• Lu CW, Jean WH, Wu CC, Shieh JS, Lin TY. Antiemetic efficacy of metoclopramide and diphenhydramine added to patient-controlled morphine analgesia: a randomised controlled trial. Eur J Anaesthesiol. 2010 Dec;27(12):1052-7. doi: 10.1097/EJA.0b013e32833f53b8.

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MeSH Terms

Interventions

Transdermal Patch; Methylprednisolone Hemisuccinate; Droperidol; Ondansetron; Ketorolac; Ibuprofen; Fentanyl; Hydrocodone

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Indomethacin; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Results Point of Contact

• Title: Dr. Jay Anderson, PI
• Organization: UNC Chapel Hill

janderson@aims.unc.edu

919-966-5136

Study Officials

• Ceib Philllips, PhD, MPH

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: May 7, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 20, 2014
• Results First Posted: August 6, 2014

Record last verified: 2014-06

Locations

US (1)