The Incremental Risk of Intraoperative Fentanyl on PONV

NCT ID: NCT03201315

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 363 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-05-31

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.

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).

Conditions

PONV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Bandschapp, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Wilhelm Ruppen, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Eckhard Mauermann, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel; University Hospital Ghent

Locations

Universitiy Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 31567573 (View on PubMed)

Other Identifiers

EKNZ 2016-01605

Identifier Type: -

Identifier Source: org_study_id