An interventional study of No NG tube gastric decompression in Postoperative Nausea and Postoperative Vomiting, sponsored by Nova Scotia Health Authority. Recruiting at 1 site in Canada. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Supportive care
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.
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.
629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.
This study's planned enrollment of 92 is below the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.
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Orthognathic surgery to include:
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:
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
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.
Participants in this group will not undergo gastric decompression following orthognathic surgery at our institution.
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).
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.
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).
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).
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).
Plan to share: No — This data will be anonymous. Participants will only be consenting to participate in this study. There is no future studies planned using this study data.
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