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

NCT07749079 | Not Yet Recruiting DMC

• 1 other identifier: ENTPONV-2026152
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PONV

Keywords

Postoperative nausea and vomiting; PONV; Nasal surgery; General anesthesia; Risk factors; Prospective cohort study; Perioperative complications

Outcome Measures

Primary Outcomes (1)

• 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.

  From the end of surgery through 24 hours after surgery

Secondary Outcomes (13)

• Incidence of Clinically Significant Postoperative Nausea and Vomiting

  At 6 hours, 24 hours, and postoperative day 3

• Incidence of Vomiting or Retching Within 24 Hours

  From the end of surgery through 24 hours after surgery

• Number of Vomiting or Retching Episodes Within 24 Hours

  From the end of surgery through 24 hours after surgery

• Use of Rescue Antiemetic Medication

  From the end of surgery through postoperative day 3

• Severity of Postoperative Pain

  At 0-2 hours, 2-6 hours, 6-12 hours, 12-24 hours, postoperative day 3, and postoperative day 30

Study Arms (1)

Adults Undergoing Nasal Surgery Under General Anesthesia

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Scheduled to undergo nasal surgery under general anesthesia
• Aged 18 years or older
• Willing and able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician, Director of the Department of Anesthesiology

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE