A Phase 4 interventional study of Ondansetron 4 MG and Lactated Ringers, Intravenous in Enhanced Recovery Pathway and Endoscopy, sponsored by Northwestern University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-15.
Sponsored by Northwestern University · Phase 4, Interventional, and Prevention
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.
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.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For 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.
Drug: Ondansetron 4 MG · Drug: Lactated Ringers, Intravenous · Other: Early Mobilization · Other: Early PO Intake
The 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.
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.
Also known as: Post-operative Nausea & Vomiting Prophylaxis
Goal directed IV fluids to be administered starting preop per the NMH Colorectal ERAS protocol (LR @ 5mL/kg/hr).
Also known as: Intravenous Hydration
Patient transferred up to the chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters and patient safety.
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.
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).
Time frame: 1-2 hours
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.
Time frame: 1-2 hours
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.
Time frame: 15 minutes
Plan to share: No
This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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