Trials / Withdrawn
WithdrawnNCT04983498
Enhanced Recovery Pathway for Endoscopy
Evaluation of an Enhanced Recovery Pathway for Endoscopy Patients Receiving Moderate Sedation
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ondansetron 4 MG | 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. |
| DRUG | Lactated Ringers, Intravenous | Goal directed IV fluids to be administered starting preop per the NMH Colorectal ERAS protocol (LR @ 5mL/kg/hr). |
| OTHER | Early Mobilization | Patient transferred up to the chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters and patient safety. |
| OTHER | Early 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. |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2021-12-01
- Completion
- 2022-01-01
- First posted
- 2021-07-30
- Last updated
- 2021-12-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04983498. Inclusion in this directory is not an endorsement.