Clinical trial NCT06422793: The Impact of Nasogastric Tube Gastric Decompression on Postoperative Nausea and Vomiting in Orthognathic Surgery
Official title: The Impact of Nasogastric Tube Gastric Decompression on Postoperative Nausea and Vomiting in Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Nausea
Postoperative Vomiting
Keywords: nasogastric tube
orthognathic surgery
gastric decompression
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 92
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Postoperative nausea and vomiting (PONV) affects up to 60% of patients after orthognathic surgery. Multiple complex mechanisms contribute to the development of PONV, but gastric pooling of blood is speculated to be the primary stimulus in this type of surgery. Nasogastric (NG) tubes can be used for gastric decompression in the peri-operative period to evacuate gastric contents/blood, with an intent to minimize PONV. This study will directly compare the incidence of PONV in participants undergoing NG tube gastric decompression and those without NG tube gastric decompression in the first 24 hours after orthognathic surgery. Participants will be randomized into two groups including no NG tube gastric decompression or NG tube gastric decompression throughout the surgery with removal one one hour postoperatively. The presence of early and/or delayed PONV will be monitored to determine the impact of NG tube gastric decompression. This study will also evaluate the impact of other variables including type of anesthesia, length of surgery, type of surgery and patient factors on the incidence of PONV in this study population.

Eligibility criteria: Inclusion Criteria:

* 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:

1. Patients who receive single-jaw surgery (i.e. BSSO \[Bilateral Sagittal Split Osteotomy\] only, or LeFort only).
2. Patients receiving double-jaw surgery (i.e. BSSO and LeFort).
3. Patients undergoing a functional genioplasty in addition to another osteotomy (i.e. BSSO and/or LeFort).

Exclusion Criteria:

* Patients will be excluded if they do not meet inclusion criteria or if they have risk factors known to directly impact PONV and/or cause delayed gastric emptying:

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

Primary outcomes:
measure: Postoperative Nausea and Vomiting
timeFrame: Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).
Secondary outcomes:
measure: NG Tube Related Complications/Factors
timeFrame: Intraoperative documentation during NG tube insertion.
measure: Incidence of Early vs Delayed PONV in our Study Population
timeFrame: Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).
measure: Other Factors Impacting PONV
timeFrame: Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).
measure: Apfel Score as a Predictor of PONV in our Study Population
timeFrame: Apfel score will be determined preoperatively. Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Victoria General Hospital
state: Nova Scotia
Study officials:
affiliation: NSHA
name: James Brady, DDS/MD
role: PRINCIPAL_INVESTIGATOR
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