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Enhanced Recovery Pathway for Endoscopy

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04983498
Enrollment
0
Registered
2021-07-30
Start date
2021-09-01
Completion date
2022-01-01
Last updated
2021-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enhanced Recovery Pathway, Endoscopy

Brief 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.

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.

Interventions

OTHEREarly PO Intake

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.

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.

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

OTHEREarly Mobilization

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

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Outpatient colonoscopy under moderate sedation * Colonoscopy Indications: Screening

Exclusion criteria

* 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 * High Fall Risk Patients * Adults unable to consent * Pregnant patients

Design outcomes

Primary

MeasureTime frameDescription
To compare recovery time stamps before and after implementing a modified ERAs for endoscopy patients in the recovery period.1-2 hoursWe will compare mean recovery times between control and intervention groups using analysis of variance (ANOVA).
To compare the incidence of postoperative nausea and vomiting before and after implementing a modified ERAs for endoscopy patients in the recovery period.1-2 hoursWe 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.

Secondary

MeasureTime frameDescription
To compare patient satisfaction scores before and after implementing a modified ERAs for endoscopy patients in the recovery period.15 minutesWe will perform a t-test of patient satisfaction scores (Press Ganey scores) between control and intervention groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026