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Trial record 9 of 9 for:    MECLIZINE

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

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ClinicalTrials.gov Identifier: NCT02625181
Recruitment Status : Completed
First Posted : December 9, 2015
Results First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Wanderer, Vanderbilt University

Brief 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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Procedure: Automated recommendation at the start of the case Procedure: Automated notification at the start of surgery Procedure: Preoperative recommendations: by email Procedure: Automated notification at the end of surgery Device: Anesthesia Information Management System (AIMS) Device: Perioperative Data Warehouse (PDW) Procedure: General anesthesia Procedure: Elective surgery Drug: Propofol Drug: Sevoflurane Drug: Isoflurane Drug: Desflurane Drug: Scopolamine Drug: Droperidol Drug: Haloperidol Drug: Dexamethasone Drug: Promethazine Drug: Meclizine Drug: Aprepitant Drug: Metoclopramide Drug: Fentanyl Drug: Sufentanil Drug: Alfentanil Drug: Remifentanil Drug: Morphine Drug: Meperidine Drug: Hydromorphone Drug: Methadone Drug: Oxycodone Drug: Oxymorphone Drug: Hydrocodone Drug: Ketamine Drug: Ondansetron Drug: Granisetron Drug: Dolasetron mesylate Drug: Palonosetron Drug: Tropisetron Drug: Ramosetron Not Applicable

Detailed Description:

Nausea and vomiting after surgery (PONV) is a common side effect of the surgical procedure, general anesthesia and opioid use occurring in about one third of patients. In addition to being very unpleasant for patients, it is associated with longer recovery room stays and increased costs. Much research has been done on prophylactic interventions that may be applied during the surgical procedure to prevent PONV. Current national guidelines recommend that a risk score is used to decide on the number of prophylactic interventions to administer to a patient. Based on specific characteristics of individual patients and the procedures that they are about to undergo, such a risk score predicts the risk of PONV for each individual. According to the national guidelines, patients with higher risks of PONV should receive more prophylactic interventions. However, in a busy operating room where the anesthesia provider performs multiple patient care tasks, closely following the recommendations to minimize the risk of PONV is often difficult.

Computers may help anesthesia providers to adhere to best practices for PONV prevention by providing so-called decision support. A decision support system for PONV automatically calculates the risk of PONV for an individual patient and presents this predicted risk to the anesthesia provider on the computer screen that is being used by the anesthesia team for record keeping. In recent studies, such decision support systems have been demonstrated to improve adherence to PONV guidelines, especially when a recommendation on the number of interventions is added to the predicted risk. However, in these studies there was still quite some room for improvement of the adherence to PONV guidelines. In general, implementation science is only beginning to understand how such decision support systems are best used to improve medical decision making and minimize practice variations among providers. Further study of how the design of decision support systems impacts the decision making of healthcare providers is therefore warranted.

In this proposed study, the investigators will implement several decision support elements for PONV that aim to help anesthesia providers to adhere to the departmental PONV guidelines during the anesthetic case. The study consists of three phases. The first phase is the preintervention phase - i.e. before the decision support has been implemented. The second phase is the first intervention phase with one CDSS feature added. The third phase is the second intervention phase with another CDSS feature added.

The decision support elements will provide information about the patient's predicted risk of PONV and the number of prophylactic interventions that the departmental guidelines recommend based on that risk. We will start with preoperative email notifications, followed by an element within the anesthesia information management system (AIMS) that are displayed around the start and end of the procedure. All forms of decision support only provide recommendations. The anesthesia provider is free to act on the message or ignore the notifications.

The investigators will compare the adherence to PONV guidelines and the actual occurrence of PONV (both nausea and emetic events: vomiting and retching) in the post-anesthesia care unit (PACU) between all study phases and between the different interventions. The goal of the comparison is to evaluate which decision support elements have an added value to optimize guideline adherence for PONV prophylaxis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27034 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
Actual Study Start Date : July 2016
Actual Primary Completion Date : November 2, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PONV clinical decision support system
Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
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: Dexamethasone
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: Fentanyl
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: Ketamine
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




Primary Outcome Measures :
  1. Adherence to PONV Guidelines [ Time Frame: A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case ]
    PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support.


Secondary Outcome Measures :
  1. PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting [ Time Frame: PACU recovery period ]
    The occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU.

  2. The Number of Prophylactic Interventions for PONV [ Time Frame: A specific time frame on the day of surgery: from the start of admission at the holding room to the end of the anesthetic case ]
    the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU.

  3. Time to Discharge From the Postanesthesia Care Unit (PACU) [ Time Frame: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU ]
    This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients (18 years and older) that are scheduled for an elective surgical procedure under general anesthesia

Exclusion Criteria:

  • Patients undergoing emergency surgery or organ transplantation
  • Patients that are transferred directly to the Intensive Care Unit after the end of the procedure
  • Patients that die intraoperatively
  • Procedures that only require a sedative level of anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625181


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Jonathan P Wanderer, MD, MPhil Vanderbilt University Medical Center, Division of Anesthesiology
  Study Documents (Full-Text)

Documents provided by Jonathan Wanderer, Vanderbilt University:

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Responsible Party: Jonathan Wanderer, Medical Director of Procedure Preparation Center, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02625181     History of Changes
Other Study ID Numbers: 151750
First Posted: December 9, 2015    Key Record Dates
Results First Posted: March 7, 2019
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Jonathan Wanderer, Vanderbilt University:
Decision support
Prediction models
PONV
prophylaxis
Decision Support Systems, Clinical
Decision Support Techniques

Additional relevant MeSH terms:
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Meclizine
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Propofol
Ketamine
Fentanyl
Sevoflurane
Sufentanil
Desflurane
Isoflurane
Alfentanil
Dexamethasone
Ondansetron
Aprepitant
Haloperidol
Palonosetron
Metoclopramide
Granisetron
Scopolamine
Ramosetron
Droperidol
Tropisetron
Dolasetron
Morphine