Risk Factors for Postoperative Nausea and Vomiting After Nasal Surgery Under General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: PONV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Risk Factors for Postoperative Nausea and Vomiting in Patients Undergoing Nasal Surgery Under General Anesthesia: A Multicenter Prospective Observational Cohort Study
Overview
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.
Primary outcome measures
- Incidence of Postoperative Nausea and Vomiting Within 24 Hours [Time frame: From the end of surgery through 24 hours after surgery]
Secondary outcome measures (12)
- Incidence of Clinically Significant Postoperative Nausea and Vomiting [Time frame: At 6 hours, 24 hours, and postoperative day 3]
- Incidence of Vomiting or Retching Within 24 Hours [Time frame: From the end of surgery through 24 hours after surgery]
- Number of Vomiting or Retching Episodes Within 24 Hours [Time frame: From the end of surgery through 24 hours after surgery]
- Use of Rescue Antiemetic Medication [Time frame: From the end of surgery through postoperative day 3]
- 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 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]
- Postoperative Fatigue at Discharge [Time frame: At hospital discharge, anticipated within 3 days after surgery]
- Postoperative Short-term Sleep Quality [Time frame: At 24 hours, postoperative day 3, and postoperative day 30]
- Postoperative Longer-term Sleep Quality [Time frame: At 24 hours, postoperative day 3, and postoperative day 30]
- Incidence of Postoperative Pulmonary Complications [Time frame: Through postoperative day 30]
- Incidence of respiratory adverse events [Time frame: Within 24 hours, through postoperative day 3, and through postoperative day 30]
- Incidence of airway rescue interventions [Time frame: Within 24 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07749079 · ENTPONV-2026152