Enhanced Recovery Pathway for Endoscopy

Northwestern University

Status and phase: Withdrawn; Phase 4

Conditions: Endoscopy; Enhanced Recovery Pathway

Treatments: Other: Early PO Intake; Drug: Ondansetron 4 MG; Other: Early Mobilization; Drug: Lactated Ringers, Intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT04983498

STU00214245

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Prospective Experimental Group

Experimental group

Description:

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.

Treatment:

Drug: Lactated Ringers, Intravenous

Other: Early PO Intake

Drug: Ondansetron 4 MG

Other: Early Mobilization

Retrospective Control Group

No Intervention group

Description:

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.