An observational study in PONV, sponsored by Eye & ENT Hospital of Fudan University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Eye & ENT Hospital of Fudan University · Observational
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:
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:
The study will use information from participant questionnaires, medical records, anesthesia records, and postoperative follow-up assessments.
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.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 208 across 93 observational studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adult patients (≥18 years) scheduled to undergo elective nasal surgery under general anesthesia at three tertiary hospitals in China. Consecutive eligible patients who provide written informed consent will be enrolled in this multicenter prospective observational cohort study to evaluate the incidence and risk factors for postoperative nausea and vomiting.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This prospective observational cohort includes adults aged 18 years or older undergoing nasal surgery under general anesthesia. No study-specific intervention will be administered. Anesthetic management, surgical care, prophylactic antiemetic therapy, analgesia, and postoperative treatment will be determined by routine clinical practice at each participating center. Perioperative patient, anesthesia, surgical, and medication-related factors will be recorded, and participants will be followed to assess postoperative nausea and vomiting and other postoperative complications.
Incidence of Postoperative Nausea and Vomiting Within 24 Hours
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.
Time frame: From the end of surgery through 24 hours after surgery
Incidence of Clinically Significant Postoperative Nausea and Vomiting
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.
Time frame: At 6 hours, 24 hours, and postoperative day 3
Incidence of Vomiting or Retching Within 24 Hours
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.
Time frame: From the end of surgery through 24 hours after surgery
Number of Vomiting or Retching Episodes Within 24 Hours
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.
Time frame: From the end of surgery through 24 hours after surgery
Use of Rescue Antiemetic Medication
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.
Time frame: From the end of surgery through postoperative day 3
Severity of Postoperative Pain
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.
Time frame: At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30
Postoperative Nasal and Related Symptoms
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.
Time frame: At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30
Postoperative Fatigue at Discharge
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.
Time frame: At hospital discharge, anticipated within 3 days after surgery
Postoperative Short-term Sleep Quality
Postoperative short-term sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire.
Time frame: At 24 hours, postoperative day 3, and postoperative day 30
Postoperative Longer-term Sleep Quality
Postoperative longer-term sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
Time frame: At 24 hours, postoperative day 3, and postoperative day 30
Incidence of Postoperative Pulmonary Complications
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.
Time frame: Through postoperative day 30
Incidence of respiratory adverse events
The proportion of participants experiencing respiratory adverse events.
Time frame: Within 24 hours, through postoperative day 3, and through postoperative day 30
Incidence of airway rescue interventions
The proportion of participants experiencing airway rescue interventions.
Time frame: Within 24 hours
Incidence of Other Postoperative Complications
The proportion of participants experiencing other clinically relevant perioperative complications.
Time frame: Within 24 hours, through postoperative day 3, and through postoperative day 30
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data will be shared through the SDB platform (https://www.scidb.cn/en) under controlled access. Access will be granted to qualified researchers whose research proposals are scientifically and ethically appropriate and approved according to the SDB data access procedures. Data users may be required to sign a data use agreement before access is granted.
Supporting information: Clinical study report, Analytic code
Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.
Of 52 non-industry observational studies under Postoperative Nausea and Vomiting, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 37. This study's planned 4 months is below that.
Counting every sponsor, half of 52 studies reached it within 11 months; a quarter within 4 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Postoperative Nausea and Vomiting →
Eye & ENT Hospital of Fudan University →