- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06226922
Risk Factors for Postoperative Nausea and Vomiting in Surgical Patients Undergoing Patient-controlled Intravenous Analgesia.
January 18, 2024 updated by: Peking Union Medical College Hospital
The purpose of this study is to identify the risk factors for postoperative nausea and vomiting (PONV) in surgical patients undergoing patient-controlled intravenous analgesia (PCIA).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Our study was a retrospective study, including patients who underwent surgery at Peking Union Medical College Hospital from July 1, 2023 to October 31, 2023 and underwent PCIA.
Patient characteristics, past medical history, surgical information, intraoperative medication information, postoperative analgesia follow-up information were obtained through the electronic medical record system.
The patients were divided into PCIA-PONV group and non-PCIA-PONV group depending on the occurrence of nausea and vomiting during PCIA, and all patients was also divided into PCIA-POV group and non-PCIA-POV according to whether vomiting occurred.
Multivariate logistic regression analysis was used to identify the risk factors for PCIA-PONV and PCIA-POV.
Study Type
Observational
Enrollment (Actual)
1371
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Peking Union Medical College Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent surgery at Peking Union Medical College Hospital from July 1, 2023 to October 31, 2023 and received patient-controlled intravenous analgesia after surgery
Description
Inclusion Criteria:
- Age ≥ 18 years
- Hospitalized patients
- Undergoing general anesthesia during surgery
Exclusion Criteria:
- Day surgery patients
- Accepting PCIA for less than 24 hours
- Medical record information is missing or unavailable.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PCIA-PONV Group
Patient-controlled intravenous analgesia (PCIA) will be used after surgery.
Patients will receive dedicated follow-up.
Routine bedside visits will be conducted twice daily after surgery to assess postoperative nausea and vomiting (PONV).
The severity of nausea will be evaluated using the Visual Analogue Scale (VAS), where 0 indicates no nausea and vomiting, and 10 represents the most unbearable nausea and vomiting.
When the PONV score is >0 or vomiting occurs, it is defined as the PCIA-PONV group.
|
No intervention
|
None PCIA-PONV Group
Patient-controlled intravenous analgesia (PCIA) will be used after surgery.
Patients will receive dedicated follow-up.
Routine bedside visits will be conducted twice daily after surgery to assess postoperative nausea and vomiting (PONV).
The severity of nausea will be evaluated using the Visual Analogue Scale (VAS), where 0 indicates no nausea and vomiting, and 10 represents the most unbearable nausea and vomiting.
When the PONV score is 0, it is defined as the None PCIA-PONV Group.
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PCIA-PONV
Time Frame: During the PCIA procedure after surgery
|
Patient-controlled intravenous analgesia (PCIA) was provided after surgery and a dedicated anesthesiologist conducted follow-up.
Routine bedside visits were conducted twice a day during the PCIA procedure to evaluate the patient's postoperative nausea and vomiting.
The degree of nausea was evaluated using the visual analogue scale (VAS), with 0 indicating no nausea or vomiting and 10 indicating the most severe form of unbearable nausea or vomiting.
When the PONV score was greater than 4 or vomiting occurs, it was defined as PCIA-PONV.
|
During the PCIA procedure after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PCIA-POV
Time Frame: During the PCIA procedure after surgery
|
Patient-controlled intravenous analgesia (PCIA) was provided after surgery and a dedicated anesthesiologist conducted follow-up.
Routine bedside visits were conducted twice a day during the PCIA procedure to evaluate the patient's postoperative nausea and vomiting.
When vomiting occurs, it was defined as PCIA-POV.
|
During the PCIA procedure after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shen Le, PhD, Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Actual)
October 31, 2023
Study Completion (Actual)
November 30, 2023
Study Registration Dates
First Submitted
January 18, 2024
First Submitted That Met QC Criteria
January 18, 2024
First Posted (Estimated)
January 26, 2024
Study Record Updates
Last Update Posted (Estimated)
January 26, 2024
Last Update Submitted That Met QC Criteria
January 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K5182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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