The Impact of Nasogastric Tube Gastric Decompression on Postoperative Nausea and Vomiting in Orthognathic Surgery
- Conditions
- Postoperative VomitingPostoperative Nausea
- Interventions
- Procedure: No NG tube gastric decompression
- Registration Number
- NCT06422793
- Lead Sponsor
- Nova Scotia Health Authority
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 92
- 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).
-
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:
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No NG Gastric Decompression No NG tube gastric decompression 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 \[2-24 hours\]).
- Primary Outcome Measures
Name Time Method Postoperative Nausea and Vomiting Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively). 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).
- Secondary Outcome Measures
Name Time Method Other Factors Impacting PONV Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively). Gain better understanding how patient demographics, length of surgery, type of surgery, and type of general anesthesia impact PONV in our study population. Participant's age (years), sex (male or female), smoking status (smoker or non-smoker), history of PONV or motion sickness (positive or negative), length of surgery (from first incision to closure), type of orthognathic surgery (LeFort, BSSO, or both), type of general anesthesia (total intravenous anesthetic vs combined volatile/ intravenous anesthetic) will be evaluated for correlation to PONV in the 24 hour postoperative period.
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). Evaluate whether participants tend to experience more early (0-2h) or delayed (2-24h) PONV, increasing our understanding of possible precipitants. This will be characterized by indicating presence of nausea or vomiting with "yes" or "no" at two different time points (early \[0-2 hours postoperatively\] vs delayed \[2-24 hours postoperatively\]).
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). Evaluating whether Apfel scores correlate to PONV and can function as an accurate predictor of PONV in our study population.The Apfel score (0-4) will be documented for each patient. Apfel score means for groups experiencing nausea and/or vomiting will be compared to Apfel score means for participants who do not experience nausea and/or vomiting.
NG Tube Related Complications/Factors Intraoperative documentation during NG tube insertion. Evaluating factors related to NG tubes including the incidence of NG tube-related complications and the length of time taken to successfully insert a NG tube. Any complications will be documented. Length of time taken to insert the tube will be recorded in seconds. This data will be described using percent for incidence and descriptive statistics.
Trial Locations
- Locations (1)
Victoria General Hospital
🇨🇦Halifax, Nova Scotia, Canada