The Impact of Nasogastric Tube Gastric Decompression on Postoperative Nausea and Vomiting in Orthognathic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorNova Scotia Health Authority
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
No NG tube gastric decompression
Procedure/SurgeryParticipants in this group will not undergo gastric decompression following orthognathic surgery at our institution.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: No NG Gastric DecompressionExperimental treatment 1 intervention
Group B: NG Gastric DecompressionNo intervention 0 interventions
Trial outcomes
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).
Time frame
Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).Secondary outcomes
1
NG Tube Related Complications/Factors
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.
Time frame
Intraoperative documentation during NG tube insertion.2
Incidence of Early vs Delayed PONV in our Study Population
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 \[2-24 hours postoperatively\]).
Time frame
Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).3
Other Factors Impacting PONV
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.
Time frame
Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).4
Apfel Score as a Predictor of PONV in our Study Population
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.
Time frame
Apfel score will be determined preoperatively. Participants will be assessed for early PONV (0-2 hours postoperatively) and delayed PONV (2-24 hours postoperatively).Sponsors and contacts
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Source ClinicalTrials.gov