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

ConditionPONV
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEye & ENT Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled to undergo nasal surgery under general anesthesia

Aged 18 years or older

Willing and able to provide written informed consent

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Adults Undergoing Nasal Surgery Under General Anesthesia

Trial outcomes

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.

Time frame
From the end of surgery through 24 hours after surgery

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: