The Incremental Risk of Intraoperative Fentanyl on PONV
1 other identifier
observational
363
1 country
1
Brief Summary
The aim of this quality control study is to describe the presence and intensity of postoperative nausea and vomiting (PONV) and its correlation with intraoperative fentanyl dosing. Additionally, the investigators will examine pain scores.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedAugust 6, 2019
August 1, 2019
4 months
May 17, 2017
August 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Any postoperative nausea and/or vomiting (PONV) within 24 hours after surgery
postoperative nausea and/or vomiting (PONV) yes/no (either by chart or by patient confirmation) within 24 hours (or next morning discharge)
within 24 hours (or next morning discharge)
Secondary Outcomes (3)
number of postoperative vomiting events within 24 hours
within 24 hours (or next morning discharge)
Any postoperative nausea and/or vomiting (PONV) while in the recovery room
first two postoperative hours
Worst pain, i.e. highest Numeric Rating Score (NRS)
within 24 hours / in recovery room (first two postoperative hours)
Other Outcomes (1)
Dose of postoperative administration of opioids
within 24 hours / in recovery room (first two postoperative hours)
Eligibility Criteria
Patients with an elevated PONV risk undergoing abdominal, gynecological, or otorhinolaryngological in-patient surgery
You may qualify if:
- In-patients with an expected simplified Apfel score of 2 or higher,
- Aged \>= 18 years, and
- Undergoing general anesthesia (with or without neuraxial or regional anesthesia.)
- in abdominal, gynecological or otorhinolaryngological surgery
You may not qualify if:
- Outpatients
- Patients with chronic pain, defined as recurring pain requiring intermittent hospitalization or regular intake of pain medication.
- Non-opioid naïve patients, defined as a history of abuse or having taken opioids within the last 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitiy Hospital Basel
Basel, 4031, Switzerland
Related Publications (1)
Mauermann E, Clamer D, Ruppen W, Bandschapp O. Association between intra-operative fentanyl dosing and postoperative nausea/vomiting and pain: A prospective cohort study. Eur J Anaesthesiol. 2019 Nov;36(11):871-880. doi: 10.1097/EJA.0000000000001081.
PMID: 31567573DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Bandschapp, PD Dr.
University Hospital, Basel, Switzerland
- PRINCIPAL INVESTIGATOR
Wilhelm Ruppen, PD Dr.
University Hospital, Basel, Switzerland
- PRINCIPAL INVESTIGATOR
Eckhard Mauermann, MD, MSc
University Hospital Basel; University Hospital Ghent
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2017
First Posted
June 28, 2017
Study Start
January 1, 2017
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
August 6, 2019
Record last verified: 2019-08