Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
NCT02625181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27034
Last updated 2019-03-07
Summary
The purpose of this study is to determine how automated recommendations are best presented to optimize the adherence to guidelines on prophylaxis for nausea and vomiting after surgery.
Conditions
- Postoperative Nausea and Vomiting
Interventions
- PROCEDURE
-
Automated recommendation at the start of the case
The first notification is the main notification that informs the anesthesia providers at the start of anesthesia of the risk score for that individual patient and the recommended number of prophylactic interventions. The notification occurs within the anesthesia information management system (AIMS)
- PROCEDURE
-
Automated notification at the start of surgery
The second notification within the AIMS will notify the anesthesia providers at the start of surgery when no prophylaxis has been given while three or more interventions were recommended.
- PROCEDURE
-
Preoperative recommendations: by email
A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.
- PROCEDURE
-
Automated notification at the end of surgery
A notification will remind anesthesia providers at the closing of surgery how many prophylactic interventions are required to adhere to the recommended number of interventions.
- DEVICE
-
Anesthesia Information Management System (AIMS)
The anesthesia electronic record keeping system
- DEVICE
-
Perioperative Data Warehouse (PDW)
The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the preoperative emails.
- PROCEDURE
-
General anesthesia
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
- PROCEDURE
-
Elective surgery
Surgical procedures that are scheduled and not an emergency.
- DRUG
-
Propofol
Anesthetic drug used to maintain general anesthesia
- DRUG
-
Sevoflurane
Anesthetic drug used to maintain general anesthesia
- DRUG
-
Isoflurane
Anesthetic drug used to maintain general anesthesia
- DRUG
-
Desflurane
Anesthetic drug used to maintain general anesthesia
- DRUG
-
Scopolamine
Prophylactic antiemetic
- DRUG
-
Droperidol
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Haloperidol
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Promethazine
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Meclizine
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Aprepitant
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Metoclopramide
Rescue antiemetic
- DRUG
-
Analgesic drug / Opioid
- DRUG
-
Sufentanil
Analgesic drug / Opioid
- DRUG
-
Alfentanil
Analgesic drug / Opioid
- DRUG
-
Remifentanil
Analgesic drug / Opioid
- DRUG
-
Morphine
Analgesic drug / Opioid
- DRUG
-
Meperidine
Analgesic drug / Opioid
- DRUG
-
Hydromorphone
Analgesic drug / Opioid
- DRUG
-
Methadone
Analgesic drug / Opioid
- DRUG
-
Oxycodone
Analgesic drug / Opioid
- DRUG
-
Oxymorphone
Analgesic drug / Opioid
- DRUG
-
Hydrocodone
Analgesic drug / Opioid
- DRUG
-
Analgetic / Analgesic drug
- DRUG
-
Ondansetron
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Granisetron
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Dolasetron mesylate
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Palonosetron
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Tropisetron
Prophylactic antiemetic \& rescue antiemetic
- DRUG
-
Ramosetron
Prophylactic antiemetic \& rescue antiemetic
Sponsors & Collaborators
-
Vanderbilt University
lead OTHER
Principal Investigators
-
Jonathan P Wanderer, MD, MPhil · Vanderbilt University Medical Center, Division of Anesthesiology
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2017-11-02
- Completion
- 2017-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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