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NCT Number: NCT07749079

Risk Factors for Postoperative Nausea and Vomiting After Nasal Surgery Under General Anesthesia

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.

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Key information

Conditions

PONV Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Postoperative Nausea and Vomiting Within 24 Hours

    Time frame: 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 outcomes

  1. Incidence of Clinically Significant Postoperative Nausea and Vomiting

    Time frame: 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.

  2. Incidence of Vomiting or Retching Within 24 Hours

    Time frame: 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.

  3. Number of Vomiting or Retching Episodes Within 24 Hours

    Time frame: 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.

  4. Use of Rescue Antiemetic Medication

    Time frame: 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.

  5. Severity of Postoperative Pain

    Time frame: 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.

  6. Postoperative Nasal and Related Symptoms

    Time frame: 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.

  7. Postoperative Fatigue at Discharge

    Time frame: 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.

  8. Postoperative Short-term Sleep Quality

    Time frame: At 24 hours, postoperative day 3, and postoperative day 30

    Postoperative short-term sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire.

  9. Postoperative Longer-term Sleep Quality

    Time frame: At 24 hours, postoperative day 3, and postoperative day 30

    Postoperative longer-term sleep quality will be assessed using the Pittsburgh Sleep Quality Index.

  10. Incidence of Postoperative Pulmonary Complications

    Time frame: 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.

  11. Incidence of respiratory adverse events

    Time frame: Within 24 hours, through postoperative day 3, and through postoperative day 30

    The proportion of participants experiencing respiratory adverse events.

  12. Incidence of airway rescue interventions

    Time frame: Within 24 hours

    The proportion of participants experiencing airway rescue interventions.

  13. Incidence of Other Postoperative Complications

    Time frame: Within 24 hours, through postoperative day 3, and through postoperative day 30

    The proportion of participants experiencing other clinically relevant perioperative complications.

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

Risk Factors for Postoperative Nausea and Vomiting in Patients Undergoing Nasal Surgery Under General Anesthesia: A Multicenter Prospective Observational Cohort Study

Acronym: N-PONV

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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