Postoperative Nausea, Postoperative Vomiting
Conditions
Keywords
nasogastric tube, orthognathic surgery, gastric decompression
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.
Interventions
PROCEDURENo NG tube gastric decompression
Participants in this group will not undergo gastric decompression following orthognathic surgery at our institution.
Sponsors
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 \[2-24 hours postoperatively\]). |
| 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. |
| 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. |
Countries
Canada
Contacts
Primary ContactKatherine A Curry, DDS
Outcome results
None listed