The Incremental Risk of Intraoperative Fentanyl on PONV

August 5, 2019 updated by: University Hospital, Basel, Switzerland

The Incremental Risk of Intraoperative Fentanyl on PONV: A Modifiable Risk Without Drawbacks?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The primary aims of this quality control study are:

  1. to determine whether there is an independent association between the intraoperative administration of fentanyl (both as a continuous and categorical variable) and PONV within 24 postoperative hours
  2. determine whether or not the intraoperative fentanyl amount can be used to successfully restratify patients for PONV beyond the simplified Apfel score for PONV

All required data is collected in regular daily practice. The following variables will be assessed by univariable models:

Preoperative variables (e.g. patient characteristics) Surgical/Anesthesia variables (e.g. type/length of surgery, antiemetics) Outcome variables (PONV, worst pain as delineated in the outcomes section), Intraoperative fentanyl measured 1) as a continuous variable and 2) by predefined limits of 0 to 0.2mg, >0.2-0.5mg, >0.5 to 0.8mg, and >8mg.

Finally for the multivariable model, the investigators will adjust for confounders, specifically for sex (m/f), history (Hx) of PONV (y/n), Hx of motion sickness (y/n), current smoker (y/n), age (years), expected duration of surgery (min; >60 min), postoperative opioids (y/n), the use of preemptive PONV Therapy (0,1,2 medications), propofol vs. inhalative agents (y/n), and surgery type (3 kinds) from the patient's electronic record. In the event that insufficient event rates are observed, we will collapse the variables into the simplified Apfel score to assess the independent value of fentanyl in predicting PONV.

In addition to a logistic model as delineated above, we will conduct the following:

  1. receiver operating characteristic (ROC) curves of the logistic model without fentanyl, with fentanyl (continuous), and with fentanyl (categorical).
  2. additionally, ROCs of a simplified model using the Apfel score, the Apfel score with fentanyl (continous), and the Apfel score with fentanyl (categorical) will be made. Comparison of area under the receiver operating characteristics(AUROCs) by DeLong
  3. net reclassification improvement (NRI) of both the logistic model with and without fentanyl as well as the Apfel score with and without fentanyl

To assess pain and administered fentanyl, we will examine pain scores by the numeric rating scale (NRS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
363

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

  • Switzerland
      • Basel, Switzerland, 4031
        • Universitiy Hospital Basel

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with an elevated PONV risk undergoing abdominal, gynecological, or otorhinolaryngological in-patient surgery

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Any postoperative nausea and/or vomiting (PONV) within 24 hours after surgery
Time Frame: within 24 hours (or next morning discharge)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
number of postoperative vomiting events within 24 hours
Time Frame: within 24 hours (or next morning discharge)
Number of times vomiting (0, 1-2, >3 times; either by chart or by patient confirmation) within 24 hours (or next morning discharge)
within 24 hours (or next morning discharge)
Any postoperative nausea and/or vomiting (PONV) while in the recovery room
Time Frame: first two postoperative hours
Postoperative nausea and/or vomiting (PONV) yes/no (either by chart or by patient confirmation) while in recovery room
first two postoperative hours
Worst pain, i.e. highest Numeric Rating Score (NRS)
Time Frame: within 24 hours / in recovery room (first two postoperative hours)
highest / worst pain score within 24 hours / in recovery room (defined as above)
within 24 hours / in recovery room (first two postoperative hours)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dose of postoperative administration of opioids
Time Frame: within 24 hours / in recovery room (first two postoperative hours)
quantification of postoperative administration of opioids 24 hours/recovery room
within 24 hours / in recovery room (first two postoperative hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EKNZ 2016-01605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on PONV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings