Enhanced Recovery Pathway for Endoscopy

Endoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04983498
• Other study ID #: STU00214245
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endoscopy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Crenshaw JT, Winslow EH. Preoperative fasting: old habits die hard. Am J Nurs. 2002 May;102(5):36-44; quiz 45. — View Citation

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. Review. — View Citation

Gan TJ. Postoperative nausea and vomiting--can it be eliminated? JAMA. 2002 Mar 13;287(10):1233-6. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1-2 hours
Primary	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.	1-2 hours
Secondary	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.	15 minutes