PONV
Conditions
Keywords
Postoperative nausea and vomiting, PONV, Nasal surgery, General anesthesia, Risk factors, Prospective cohort study, Perioperative complications
Brief summary
The goal of this observational study is to learn how often postoperative nausea and vomiting occur in adults undergoing nasal surgery under general anesthesia and to identify factors associated with these events. The study will also describe other postoperative complications and factors that may affect recovery. The main questions it aims to answer are: * How many participants experience nausea, retching, or vomiting within 24 hours after surgery? * Which patient characteristics, anesthesia-related factors, surgical factors, and perioperative medications are associated with postoperative nausea and vomiting? * What other postoperative complications and nasal-related symptoms occur after surgery? Approximately 1,000 adults undergoing nasal surgery under general anesthesia at three hospitals in China will be enrolled. This is an observational study, and participation will not change the anesthesia, surgery, medications, or other medical care selected by the treating clinical team. Participants will: * Complete assessments before surgery about their medical history, previous nausea or vomiting, anxiety, sleep, and recovery status * Receive routine anesthesia and surgical care * Be assessed for nausea, retching, vomiting, pain, nasal discomfort, and other complications during the first 24 hours after surgery * Complete follow-up assessments after surgery, including follow-up by telephone after discharge, for up to 6 months The study will use information from participant questionnaires, medical records, anesthesia records, and postoperative follow-up assessments.
Detailed description
This multicenter, prospective observational cohort study will evaluate postoperative nausea and vomiting in adults undergoing nasal surgery under general anesthesia at three hospitals in China. The study is designed to characterize the occurrence, timing, and severity of postoperative nausea and vomiting and to examine associations with patient-related, anesthesia-related, surgical, and perioperative management factors. No study-specific treatment or change to routine clinical care will be required. Decisions regarding anesthetic technique, airway management, analgesia, antiemetic prophylaxis, fluid administration, surgical management, and postoperative treatment will be made by the clinical team according to usual practice at each participating center. Data will be collected prospectively from participant interviews and questionnaires, medical records, anesthesia information systems, case report forms, and postoperative follow-up assessments. Preoperative data will include demographic and clinical characteristics, previous postoperative or post-discharge nausea and vomiting, motion sickness history, comorbidities, medication history, smoking and alcohol history, anxiety and depression, sleep quality, fasting duration, and baseline recovery status. Perioperative data will include the type and duration of surgery, anesthetic and analgesic medications, antiemetic use, airway management, intraoperative fluids, physiologic measurements, adverse events, surgical field conditions, blood loss, and nasal surgery-specific factors such as nasal packing and procedure-related characteristics. After surgery, participants will be assessed for nausea, retching, vomiting, use and response to rescue antiemetics, pain, fatigue, sleep quality, respiratory events, and nasal-related discomfort. Postoperative nausea and vomiting will be evaluated during prespecified intervals within the first 24 hours after surgery. Additional follow-up will assess post-discharge nausea and vomiting, postoperative complications, pain, sleep, psychological status, and nasal symptoms through telephone or in-person assessments for up to 6 months. The collected data will be used to estimate the incidence of postoperative nausea and vomiting and to explore independent risk factors using multivariable statistical models. The study will also establish a prospective perioperative database to support future risk-prediction research and optimization of perioperative care for patients undergoing nasal surgery.
Interventions
None listed
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo nasal surgery under general anesthesia * Aged 18 years or older * Willing and able to provide written informed consent
Exclusion criteria
* Unable to cooperate with study procedures or complete study assessments for any reason, including language barriers, cognitive impairment, or inability to complete the questionnaires * Considered unsuitable for participation by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Nausea and Vomiting Within 24 Hours | From the end of surgery through 24 hours after surgery | The proportion of participants who experience any episode of nausea, retching, or vomiting during the first 24 hours after surgery. Postoperative nausea and vomiting will be assessed during the following intervals: 0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours after anesthesia induction. A participant will be considered to have postoperative nausea and vomiting if nausea, retching, or vomiting occurs at any time during the 24-hour observation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Clinically Significant Postoperative Nausea and Vomiting | At 6 hours, 24 hours, and postoperative day 3 | The proportion of participants with clinically significant postoperative nausea and vomiting, defined as a total score of 50 or greater on the Postoperative Nausea and Vomiting Intensity Scale at any assessment. |
| Incidence of Vomiting or Retching Within 24 Hours | From the end of surgery through 24 hours after surgery | The proportion of participants who experience at least one episode of vomiting or retching within 24 hours after surgery. Events reported by either the participant or healthcare personnel will be included. |
| Number of Vomiting or Retching Episodes Within 24 Hours | From the end of surgery through 24 hours after surgery | The total number of vomiting or retching episodes experienced by each participant during the first 24 hours after surgery. Multiple episodes occurring within 5 minutes will be counted as one event unless separated by a clearly defined symptom-free interval. |
| Use of Rescue Antiemetic Medication | From the end of surgery through postoperative day 3 | The proportion of participants receiving rescue antiemetic medication after surgery. The medication name, dose, administration time, and clinical response will be recorded. Response will be categorized as complete resolution, improvement, or no response. |
| Severity of Postoperative Pain | At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30 | Postoperative pain at rest and with movement will be assessed using an 11-point Numeric Rating Scale, ranging from 0 to 10, with higher scores indicating greater pain intensity. Use of rescue analgesic medication will also be recorded. |
| Postoperative Nasal and Related Symptoms | At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30 | The severity of nasal and related postoperative symptoms will be assessed using individual 6-point scales ranging from 0 to 5, with higher scores indicating more severe symptoms. Symptoms include nasal obstruction, nasal discharge or blood-stained discharge, difficulty breathing through the nose, nasal pain or swelling, headache, dizziness, periocular discomfort, tearing, ear fullness, ear pain, facial pain or pressure, sleep disturbance due to nasal symptoms, and reduced sense of smell or taste. |
| Postoperative Fatigue at Discharge | At hospital discharge, anticipated within 3 days after surgery | Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. Higher and lower scores will be interpreted according to the validated scoring method of the instrument. |
| Postoperative Short-term Sleep Quality | At 24 hours, postoperative day 3, and postoperative day 30 | Postoperative short-term sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire. |
| Postoperative Longer-term Sleep Quality | At 24 hours, postoperative day 3, and postoperative day 30 | Postoperative longer-term sleep quality will be assessed using the Pittsburgh Sleep Quality Index. |
| Incidence of Postoperative Pulmonary Complications | Through postoperative day 30 | The proportion of participants who develop one or more postoperative pulmonary complications. Pulmonary complications will be classified according to the European Perioperative Clinical Outcome definitions and may include respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis. |
| Incidence of respiratory adverse events | Within 24 hours, through postoperative day 3, and through postoperative day 30 | The proportion of participants experiencing respiratory adverse events. |
| Incidence of airway rescue interventions | Within 24 hours | The proportion of participants experiencing airway rescue interventions. |
| Incidence of Other Postoperative Complications | Within 24 hours, through postoperative day 3, and through postoperative day 30 | The proportion of participants experiencing other clinically relevant perioperative complications. |
Outcome results
None listed