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Enhanced Recovery PathwayPhase 4NCT04983498

Enhanced Recovery Pathway for Endoscopy

A Phase 4 study testing Ondansetron 4 MG, Lactated Ringers, Intravenous and Early Mobilization in people with Enhanced Recovery Pathway and Endoscopy, run by Northwestern University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to compare an Enhanced Recovery Pathway to the current pre-operative/recovery practices of the endoscopy department on patient post-procedure outcomes. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Enhanced Recovery Pathway, Endoscopy
What is being tested?
Ondansetron 4 MG, Lactated Ringers, Intravenous and Early Mobilization
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Sep 2021to 1 Jan 2022
Phase
Phase 4
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Outpatient colonoscopy under moderate sedation
  • Colonoscopy Indications: Screening

Who cannot join

  • More than one sedation procedure scheduled same day
  • Allergy to ondansetron
  • Past PONV requiring scopolamine patches
  • Diagnoses: ESRD, heart failure, cirrhosis, long QT syndrome
  • Patients requiring fluid restrictions, such as dialysis patients
  • Post-procedure NPO requirements, such as procedure-related NPO status (stent placement, pneumatic dilation, etc.) or second procedure in another location
Show all 9Show fewer
  • High Fall Risk Patients
  • Adults unable to consent
  • Pregnant patients

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Evaluation of an Enhanced Recovery Pathway for Endoscopy Patients Receiving Moderate Sedation

The purpose of this study is to compare an Enhanced Recovery Pathway to the current pre-operative/recovery practices of the endoscopy department on patient post-procedure outcomes.

Read the detailed description

Every 4th to 5th patient that checks in to the endoscopy department for their procedure will be screened for eligibility requirements. If eligible for the study, the patient will be informed about the study and potential risks. All patients giving written informed consent will be enrolled into the enhanced recovery protocol (ERP) [nursing managed ERP: goal-directed fluid management (Lactated Ringer's Solution at 5mL/kg/hr), PONV prophylaxis for an apfel score of 2 or greater (ondansetron 4 mg IV), early mobilization up to chair (within 5-30 minutes of admission to the recovery room), and early PO intake within 15-30 minutes of admission to the recovery room post-procedure] for their procedure.

Being tested
Ondansetron 4 MG, Lactated Ringers, Intravenous, Early Mobilization, Early PO Intake

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ondansetron 4 MGDrug

    Also called Post-operative Nausea & Vomiting Prophylaxis

    PONV prophylaxis for participants with an apfel score of 2 or greater (ondansetron 4 mg IV), an additional dose of ondansetron 4mg IV will be available in recovery if the patient has nausea/vomiting despite prophylaxis.

  • Lactated Ringers, IntravenousDrug

    Also called Intravenous Hydration

    Goal directed IV fluids to be administered starting preop per the NMH Colorectal ERAS protocol (LR @ 5mL/kg/hr).

  • Early MobilizationOther

    Patient transferred up to the chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters and patient safety.

  • Early PO IntakeOther

    Patient will be offered PO intake within 15-30 minutes of admission to the recovery room post-procedure based on nursing parameters and patient safety.

Study groups in NCT04983498
Study groupRoleWhat they receive
Prospective Experimental GroupExperimentalFor the experimental group, we will recruit 200 participants who will receive the Enhanced Recovery Pathway, which will be ordered as a standing order set by the attending provider and managed by their peri-procedural nurses. The modified ERP for this study includes the following interventions: nursing managed order sets with ERP instructions to receive goal-directed fluid management within anesthesia approved parameters utilizing the NMH Colorectal ERAS protocol for IV fluid administration, PONV prophylaxis for participants with an apfel score of 2 or greater (ondansetron 4 mg IV), an additional dose of ondansetron 4mg IV will be available in recovery if the patient has nausea/vomiting despite prophylaxis, early mobilization up to chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters, and early PO intake within 15-30 minutes of admission to the recovery room post-procedure based on nursing parameters.
Receives: Drug: Ondansetron 4 MG; Drug: Lactated Ringers, Intravenous; Other: Early Mobilization; Other: Early PO Intake
Retrospective Control GroupNo interventionThe retrospective group will consist of 200 randomly selected medical records of patients who had colonoscopy procedures for a 6 month period prior to study implementation (between 10/1/2019 to 4/1/2020). The retrospective control group will have received the current standard of care including: IV fluids for management of intra-procedural hypotension as indicated/ordered by the physician, PO intake at 30-45 minutes, up to a chair at 60 minutes, and all procedure related complications will have been treated (e.g. PONV) per physician order as is the current standard of practice in the GI Lab recovery area.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare recovery time stamps before and after implementing a modified ERAs for endoscopy patients in the recovery period.

    We will compare mean recovery times between control and intervention groups using analysis of variance (ANOVA).

    Measured: 1-2 hours

  2. To compare the incidence of postoperative nausea and vomiting before and after implementing a modified ERAs for endoscopy patients in the recovery period.

    We will perform a Chi-square analysis for presence or absence of nausea and/or vomiting in the recovery period (measured by: administration of anti-emetic, documentation on N/V flowchart, and/or documentation in nursing narrative note) between control and intervention groups.

    Measured: 1-2 hours

Secondary outcomes (1)

  1. To compare patient satisfaction scores before and after implementing a modified ERAs for endoscopy patients in the recovery period.

    We will perform a t-test of patient satisfaction scores (Press Ganey scores) between control and intervention groups.

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion1 Jan 2022 (estimated)

Why it stopped: Investigator left organization before study initiated.

Resources

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 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983498
Sponsor's protocol ID
STU00214245
Status last verified
Nov 2021
First submitted
20 Jul 2021
Last updated
15 Dec 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alghanem SM, Massad IM, Rashed EM, Abu-Ali HM, Daradkeh SS. Optimization of anesthesia antiemetic measures versus combination therapy using dexamethasone or ondansetron for the prevention of postoperative nausea and vomiting. Surg Endosc. 2010 Feb;24(2):353-8. doi: 10.1007/s00464-009-0567-3. Epub 2009 Jun 11.

    PubMed 19517165

  • Amornyotin S. Sedation-related complications in gastrointestinal endoscopy. World J Gastrointest Endosc. 2013 Nov 16;5(11):527-33. doi: 10.4253/wjge.v5.i11.527.

    PubMed 24255744

  • Brown JK, Singh K, Dumitru R, Chan E, Kim MP. The Benefits of Enhanced Recovery After Surgery Programs and Their Application in Cardiothoracic Surgery. Methodist Debakey Cardiovasc J. 2018 Apr-Jun;14(2):77-88. doi: 10.14797/mdcj-14-2-77.

    PubMed 29977464

  • Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.

    PubMed 15190136

  • Ellett ML. Review of propofol and auxiliary medications used for sedation. Gastroenterol Nurs. 2010 Jul-Aug;33(4):284-95; quiz 296-7. doi: 10.1097/SGA.0b013e3181eac371.

    PubMed 20679780

  • Crenshaw JT, Winslow EH. Preoperative fasting: old habits die hard. Am J Nurs. 2002 May;102(5):36-44; quiz 45. doi: 10.1097/00000446-200205000-00033.

    PubMed 12006853

  • Gan TJ. Postoperative nausea and vomiting--can it be eliminated? JAMA. 2002 Mar 13;287(10):1233-6. doi: 10.1001/jama.287.10.1233. No abstract available.

    PubMed 11886298

  • Joliat GR, Ljungqvist O, Wasylak T, Peters O, Demartines N. Beyond surgery: clinical and economic impact of Enhanced Recovery After Surgery programs. BMC Health Serv Res. 2018 Dec 29;18(1):1008. doi: 10.1186/s12913-018-3824-0.

    PubMed 30594252

  • Lichtenstein GR, Cohen LB, Uribarri J. Review article: Bowel preparation for colonoscopy--the importance of adequate hydration. Aliment Pharmacol Ther. 2007 Sep 1;26(5):633-41. doi: 10.1111/j.1365-2036.2007.03406.x.

    PubMed 17697197

  • Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

    PubMed 28097305

  • Saraghi M. Intraoperative Fluids and Fluid Management for Ambulatory Dental Sedation and General Anesthesia. Anesth Prog. 2015 Winter;62(4):168-76; quiz 177. doi: 10.2344/0003-3006-62.4.168.

    PubMed 26650497

  • Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res. 2016 Sep-Dec;10(3):388-396. doi: 10.4103/0259-1162.179310.

    PubMed 27746521

  • Som A, Bhattacharjee S, Maitra S, Arora MK, Baidya DK. Combination of 5-HT3 Antagonist and Dexamethasone Is Superior to 5-HT3 Antagonist Alone for PONV Prophylaxis After Laparoscopic Surgeries: A Meta-analysis. Anesth Analg. 2016 Dec;123(6):1418-1426. doi: 10.1213/ANE.0000000000001617.

    PubMed 27870735

  • Weinberg L, Faulkner M, Tan CO, Liu DH, Tay S, Nikfarjam M, Peyton P, Story D. Fluid prescription practices of anesthesiologists managing patients undergoing elective colonoscopy: an observational study. BMC Res Notes. 2014 Jun 10;7:356. doi: 10.1186/1756-0500-7-356.

    PubMed 24916073

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ondansetron 4 MG, Lactated Ringers, Intravenous and Early Mobilization in people with Enhanced Recovery Pathway and Endoscopy, run by Northwestern 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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 15 Dec 2021. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

To compare recovery time stamps before and after implementing a modified ERAs for endoscopy patients in the recovery period. (time frame: 1-2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04983498, which also lists 14 linked publications.

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 15 Dec 2021.

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