Postoperative Nausea and VomitingNCT02625181
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
A study testing Automated recommendation at the start of the case, Automated notification at the start of surgery and Preoperative recommendations: by email in people with Postoperative Nausea and Vomiting, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Automated recommendation at the start of the case, Automated notification at the start of surgery and Preoperative recommendations: by email
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,034 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (18 years and older) that are scheduled for an elective surgical procedure under general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Automated recommendation at the start of the case, Automated notification at the start of surgery, Preoperative recommendations: by email, Automated notification at the end of surgery, Anesthesia Information Management System (AIMS)
- Keywords
- Decision support, Prediction models, PONV, prophylaxis, Decision Support Systems, Clinical, Decision Support Techniques
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated recommendation at the start of the caseProcedure or surgery
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)
Automated notification at the start of surgeryProcedure or 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.
Preoperative recommendations: by emailProcedure or surgery
A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.
Automated notification at the end of surgeryProcedure or 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.
Anesthesia Information Management System (AIMS)Device
The anesthesia electronic record keeping system
Perioperative Data Warehouse (PDW)Device
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.
General anesthesiaProcedure or surgery
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
Elective surgeryProcedure or surgery
Surgical procedures that are scheduled and not an emergency.
PropofolDrug
Anesthetic drug used to maintain general anesthesia
SevofluraneDrug
Anesthetic drug used to maintain general anesthesia
IsofluraneDrug
Anesthetic drug used to maintain general anesthesia
DesfluraneDrug
Anesthetic drug used to maintain general anesthesia
ScopolamineDrug
Prophylactic antiemetic
DroperidolDrug
Prophylactic antiemetic \& rescue antiemetic
HaloperidolDrug
Prophylactic antiemetic \& rescue antiemetic
DexamethasoneDrug
Prophylactic antiemetic \& rescue antiemetic
PromethazineDrug
Prophylactic antiemetic \& rescue antiemetic
MeclizineDrug
Prophylactic antiemetic \& rescue antiemetic
AprepitantDrug
Prophylactic antiemetic \& rescue antiemetic
MetoclopramideDrug
Rescue antiemetic
FentanylDrug
Analgesic drug / Opioid
SufentanilDrug
Analgesic drug / Opioid
AlfentanilDrug
Analgesic drug / Opioid
RemifentanilDrug
Analgesic drug / Opioid
MorphineDrug
Analgesic drug / Opioid
MeperidineDrug
Analgesic drug / Opioid
HydromorphoneDrug
Analgesic drug / Opioid
MethadoneDrug
Analgesic drug / Opioid
OxycodoneDrug
Analgesic drug / Opioid
OxymorphoneDrug
Analgesic drug / Opioid
HydrocodoneDrug
Analgesic drug / Opioid
KetamineDrug
Analgetic / Analgesic drug
OndansetronDrug
Prophylactic antiemetic \& rescue antiemetic
GranisetronDrug
Prophylactic antiemetic \& rescue antiemetic
Dolasetron mesylateDrug
Prophylactic antiemetic \& rescue antiemetic
PalonosetronDrug
Prophylactic antiemetic \& rescue antiemetic
TropisetronDrug
Prophylactic antiemetic \& rescue antiemetic
RamosetronDrug
Prophylactic antiemetic \& rescue antiemetic
| Study group | Role | What they receive |
|---|---|---|
| PONV clinical decision support system | Experimental | Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to PONV Guidelines
PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support.
Measured: A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case
Secondary outcomes (3)
PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting
The occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU.
Measured: PACU recovery period
The Number of Prophylactic Interventions for PONV
the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU.
Measured: 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
Time to Discharge From the Postanesthesia Care Unit (PACU)
This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days
Measured: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJul 2016
- Primary completion2 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Wanderer, Vanderbilt University
- Investigators
- Jonathan P Wanderer, MD, MPhil, Principal investigator, Vanderbilt University Medical Center, Division of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625181
- Sponsor's protocol ID
- 151750
- Status last verified
- Mar 2019
- First submitted
- 12 Nov 2015
- Last updated
- 7 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
- ClinicalTrials.gov ID
- NCT02625181
- Acronym / sponsor ID
- 151750
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Decision support, Prediction models, PONV, prophylaxis, Decision Support Systems, Clinical, Decision Support Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,034 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Posted 7 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PONV clinical decision support system | Experimental | 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: RamosetronAutomated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (18 years and older) that are scheduled for an elective surgical procedure under general anesthesia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated recommendation at the start of the caseThe 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 or surgery | PONV clinical decision support system |
| Automated notification at the start of surgeryThe 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 or surgery | PONV clinical decision support system |
| Preoperative recommendations: by emailA recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center. | Procedure or surgery | PONV clinical decision support system |
| Automated notification at the end of surgeryA notification will remind anesthesia providers at the closing of surgery how many prophylactic interventions are required to adhere to the recommended number of interventions. | Procedure or surgery | PONV clinical decision support system |
| Anesthesia Information Management System (AIMS)The anesthesia electronic record keeping system | Device | PONV clinical decision support system |
| 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. | Device | PONV clinical decision support system |
| General anesthesiaAny anesthetic drugs that are used to induce general anesthesia above the level of sedation. | Procedure or surgery | PONV clinical decision support system |
| Elective surgerySurgical procedures that are scheduled and not an emergency. | Procedure or surgery | PONV clinical decision support system |
| PropofolAnesthetic drug used to maintain general anesthesia | Drug | PONV clinical decision support system |
| SevofluraneAnesthetic drug used to maintain general anesthesia | Drug | PONV clinical decision support system |
| IsofluraneAnesthetic drug used to maintain general anesthesia | Drug | PONV clinical decision support system |
| DesfluraneAnesthetic drug used to maintain general anesthesia | Drug | PONV clinical decision support system |
| ScopolamineProphylactic antiemetic | Drug | PONV clinical decision support system |
| DroperidolProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| HaloperidolProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| DexamethasoneProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| PromethazineProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| MeclizineProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| AprepitantProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| MetoclopramideRescue antiemetic | Drug | PONV clinical decision support system |
| FentanylAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| SufentanilAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| AlfentanilAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| RemifentanilAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| MorphineAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| MeperidineAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| HydromorphoneAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| MethadoneAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| OxycodoneAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| OxymorphoneAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| HydrocodoneAnalgesic drug / Opioid | Drug | PONV clinical decision support system |
| KetamineAnalgetic / Analgesic drug | Drug | PONV clinical decision support system |
| OndansetronProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| GranisetronProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| Dolasetron mesylateProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| PalonosetronProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| TropisetronProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
| RamosetronProphylactic antiemetic \& rescue antiemetic | Drug | PONV clinical decision support system |
Primary outcome
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.
3 secondary outcomes
PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting
Time frame: PACU recovery period
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan P Wanderer, MD, MPhil principal investigator
Vanderbilt University Medical Center, Division of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated recommendation at the start of the case, Automated notification at the start of surgery and Preoperative recommendations: by email in people with Postoperative Nausea and Vomiting, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019; AzTrials last refreshed its copy on 26 Oct 2026.