The Impact of Nasogastric Tube Gastric Decompression on Postoperative Nausea and Vomiting in Orthognathic Surgery

NCT06422793 | Recruiting

• 1 other identifier: 1030776
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the incidence of postoperative nausea and vomiting during the first 24 hours following corrective jaw surgery (orthognathic surgery) in patients with and without nasogastric tube gastric decompression.

Conditions

Postoperative Nausea; Postoperative Vomiting

Keywords

nasogastric tube; orthognathic surgery; gastric decompression

Outcome Measures

Primary Outcomes (1)

• Postoperative Nausea and Vomiting

  The primary outcome for this study is PONV characterized by nausea and/or emesis in participants subject to one of two NG tube gastric decompression protocols during the 24-hour postoperative period. This will be characterized by indicating presence of nausea or vomiting with "yes" or "no" at two different time points (early vs delayed PONV).

  Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).

Secondary Outcomes (4)

• NG Tube Related Complications/Factors

  Intraoperative documentation during NG tube insertion.

• Incidence of Early vs Delayed PONV in our Study Population

  Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).

• Other Factors Impacting PONV

  Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).

• Apfel Score as a Predictor of PONV in our Study Population

  Apfel score will be determined preoperatively. Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).

Study Arms (2)

No NG Gastric Decompression

EXPERIMENTAL

No NG tube gastric decompression for orthognathic surgery. This group will not have a NG tube inserted. The remainder of their surgical care will be identical to the other group. PONV will be evaluated by nursing and surgical team at two time points in the 24 hour postoperative period (early \[0-2 hours\] and delayed \[2-24 hours\]).

Procedure: No NG tube gastric decompression

NG Gastric Decompression

NO INTERVENTION

Participants will undergo NG tube gastric decompression according to our institution's typical gastric decompression regimen. Once patients are anesthetized and intubated, and a #14 French NG tube will be inserted in the naris opposite the nasotracheal tube and hooked up to low suction to confirm placement. If in the correct position, gastric contents will be seen in suction tubing. If no gastric contents are seen, the NG tube will be adjusted accordingly. The NG tube will be connected to suction until all stomach contents are effectively removed, as demonstrated by no new secretions in the suction tubing. It will then be disconnected from suction, secured with tape throughout surgery and temporarily hooked back up to suction at the end of surgery to reconfirm position and suction stomach contents present. The NG tube will then be secured and left in place for one hour on intermittent suction following arrival to the recovery unit. After one hour, the NG tube will be removed.

Interventions

No NG tube gastric decompression PROCEDURE

Participants in this group will not undergo gastric decompression following orthognathic surgery at our institution.

No NG Gastric Decompression

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 16 at the time of consent undergoing orthognathic surgery for the correction of dentofacial deformities at the Victoria General Hospital during the study period.
• Orthognathic surgery to include:
• Patients who receive single-jaw surgery (i.e. BSSO \[Bilateral Sagittal Split Osteotomy\] only, or LeFort only).
• Patients receiving double-jaw surgery (i.e. BSSO and LeFort).
• Patients undergoing a functional genioplasty in addition to another osteotomy (i.e. BSSO and/or LeFort).

You may not qualify if:

• Patients under the age of 16 at the time of consent.
• Patients contraindicated to undergo elective surgery, including pregnant patients.
• Patients undergoing a functional genioplasty procedure only.
• Patients taking GLP-1 receptor agonists).
• Patients with known gastroparesis.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Victoria General Hospital

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

Related Publications (18)

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  PMID: 9717590 BACKGROUND

• Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005.

  PMID: 10730546 BACKGROUND

• Apipan B, Rummasak D, Wongsirichat N. Postoperative nausea and vomiting after general anesthesia for oral and maxillofacial surgery. J Dent Anesth Pain Med. 2016 Dec;16(4):273-281. doi: 10.17245/jdapm.2016.16.4.273. Epub 2016 Dec 31.

  PMID: 28879315 BACKGROUND

• Zhong W, Shahbaz O, Teskey G, Beever A, Kachour N, Venketaraman V, Darmani NA. Mechanisms of Nausea and Vomiting: Current Knowledge and Recent Advances in Intracellular Emetic Signaling Systems. Int J Mol Sci. 2021 May 28;22(11):5797. doi: 10.3390/ijms22115797.

  PMID: 34071460 BACKGROUND

• Dobbeleir M, De Coster J, Coucke W, Politis C. Postoperative nausea and vomiting after oral and maxillofacial surgery: a prospective study. Int J Oral Maxillofac Surg. 2018 Jun;47(6):721-725. doi: 10.1016/j.ijom.2017.11.018. Epub 2018 Jan 1.

  PMID: 29301675 BACKGROUND

• Silva AC, O'Ryan F, Poor DB. Postoperative nausea and vomiting (PONV) after orthognathic surgery: a retrospective study and literature review. J Oral Maxillofac Surg. 2006 Sep;64(9):1385-97. doi: 10.1016/j.joms.2006.05.024.

  PMID: 16916674 BACKGROUND

• Apfel CC, Roewer N. Risk assessment of postoperative nausea and vomiting. Int Anesthesiol Clin. 2003 Fall;41(4):13-32. doi: 10.1097/00004311-200341040-00004. No abstract available.

  PMID: 14574212 BACKGROUND

• Laskin DM, Carrico CK, Wood J. Predicting postoperative nausea and vomiting in patients undergoing oral and maxillofacial surgery. Int J Oral Maxillofac Surg. 2020 Jan;49(1):22-27. doi: 10.1016/j.ijom.2019.06.016. Epub 2019 Jun 21.

  PMID: 31230771 BACKGROUND

• Pourtaheri N, Peck CJ, Maniskas S, Park KE, Allam O, Chandler L, Smetona J, Yang J, Wilson A, Dinis J, Lopez J, Steinbacher DM. A Comprehensive Single-Center Analysis of Postoperative Nausea and Vomiting Following Orthognathic Surgery. J Craniofac Surg. 2022 Mar-Apr 01;33(2):584-587. doi: 10.1097/SCS.0000000000008052.

  PMID: 34510064 BACKGROUND

• Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.

  PMID: 24356162 BACKGROUND

• Sanaie S, Mahmoodpoor A, Najafi M. Nasogastric tube insertion in anaesthetized patients: a comprehensive review. Anaesthesiol Intensive Ther. 2017;49(1):57-65. doi: 10.5603/AIT.a2017.0001. Epub 2017 Jan 13.

  PMID: 28084614 BACKGROUND

• Kerger KH, Mascha E, Steinbrecher B, Frietsch T, Radke OC, Stoecklein K, Frenkel C, Fritz G, Danner K, Turan A, Apfel CC; IMPACT Investigators. Routine use of nasogastric tubes does not reduce postoperative nausea and vomiting. Anesth Analg. 2009 Sep;109(3):768-73. doi: 10.1213/ane.0b013e3181aed43b.

  PMID: 19690245 BACKGROUND

• Wang J, Zhang Z. Gastric Negative Pressure Suction Method Reduces the Incidence of PONV after Orthognathic Surgery. Front Surg. 2022 May 20;9:882726. doi: 10.3389/fsurg.2022.882726. eCollection 2022.

  PMID: 35669253 BACKGROUND

• Schmitt ARM, Ritto FG, de Azevedo JGRL, Medeiros PJD, de Mesquita MCM. Efficacy of Gastric Aspiration in Reducing Postoperative Nausea and Vomiting After Orthognathic Surgery: A Double-Blind Prospective Study. J Oral Maxillofac Surg. 2017 Apr;75(4):701-708. doi: 10.1016/j.joms.2016.10.002. Epub 2016 Oct 12.

  PMID: 27816732 BACKGROUND

• Maza, C., López, A. M., Kulyapina, A., Leno, B., Tousidonis, M., Garcia, A. & Salmerón, J. I. (2013). Orthognathic surgery: nasogastric tube responsible of the nausea and vomiting?. International Journal of Oral and Maxillofacial Surgery, 42(10), 1333.

  BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• James Brady, DDS/MD

  NSHA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine A Curry, DDS

CONTACT

9024732070; katherinea.curry@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded from their treatment group to minimize placebo effect, although they may later recall NG tube presence/removal if they belong in the NG group. Surgeons and anesthesiologists will not be blinded, as the nature of the study is not conducive to a double-blinded method.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: This is a prospective study for patients undergoing orthognathic surgery at the Victoria General Hospital who meet study inclusion criteria. Participants are randomized into one of two study groups represented by no NG tube gastric decompression or NG tube gastric decompression intra-operatively and for one hour post-operatively. Participants are sequentially assigned to their study group using a randomized protocol list at the time of enrolment.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: December 4, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)