Role of Apfel's Score in Predicting Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

The goal of this observational study is to assess the role of Apfel's score in predicting postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy in patients with symptomatic cholelithiasis. The main questions it aims to answer are:

1. Does Apfel's score accurately predict the occurrence of PONV after laparoscopic cholecystectomy?
2. Which components of Apfel's score are most strongly associated with PONV?

Participants will undergo laparoscopic cholecystectomy under general anesthesia. Researchers will calculate each participant's Apfel score preoperatively, and postoperative outcomes, such as nausea and vomiting, will be monitored for 24 to 48 hours. Researchers will compare PONV incidence among patients with varying Apfel scores to determine if higher scores correlate with a higher risk of PONV.

Study Overview

• Status: Completed
• Conditions: Post Operative Nausea and Vomiting (PONV); APFEL RİSK SCORE

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Nepal
  • Madesh
    • Birgunj, Madesh, Nepal, Nepal
      • National Medical College and Teaching Hospital, Birgunj

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients who are undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. These patients are treated at the Department of General Surgery at National Medical College Teaching Hospital, Birgunj, Nepal.

Description

Inclusion Criteria:

• Patients aged 18 to 90 years.
• Patient scheduled for elective laparoscopic cholecystectomy for symptomatic cholelithiasis.
• Patients who provided written informed consent to participate in the study.

Exclusion Criteria:

• Patients receiving prophylactic antiemetic medications prior to surgery.
• Patients on opioid analgesics for reasons other than the surgical procedure.
• Pregnant women.
• Patients whose laparoscopic cholecystectomy was converted to open cholecystectomy during the operation.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Nausea and Vomiting (PONV)	The number of patients who experience nausea and/or vomiting within 24 hours after laparoscopic cholecystectomy.	Assessed for 24 hours post-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship Between Apfel's Score and PONV Incidence	Evaluating the correlation between the Apfel's score (0-4) and the likelihood of PONV in patients after surgery.	Assessed for 24 hours post-surgery.

Collaborators and Investigators

• Sponsor: National Medical College Birgunj

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2022
• Primary Completion (Actual): February 6, 2023
• Study Completion (Actual): October 28, 2023

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: PG-NMC/541/078-079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators may share de-identified Individual Participant Data (IPD) with other researchers upon reasonable request. Access to the data will be granted after approval by the Institutional Review Committee, and a data-sharing agreement will be required to ensure participant confidentiality and compliance with ethical standards.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No