The Incremental Risk of Intraoperative Fentanyl on PONV

PONV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201315
• Other study ID #: EKNZ 2016-01605
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: May 2017

Study information

• Verified date: August 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PONV

Locations

Country	Name	City	State
Switzerland	Universitiy Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dose of postoperative administration of opioids	quantification of postoperative administration of opioids 24 hours/recovery room	within 24 hours / in recovery room (first two postoperative hours)
Primary	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	number of postoperative vomiting events within 24 hours	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)
Secondary	Any postoperative nausea and/or vomiting (PONV) while in the recovery room	Postoperative nausea and/or vomiting (PONV) yes/no (either by chart or by patient confirmation) while in recovery room	first two postoperative hours
Secondary	Worst pain, i.e. highest Numeric Rating Score (NRS)	highest / worst pain score within 24 hours / in recovery room (defined as above)	within 24 hours / in recovery room (first two postoperative hours)