Enhanced Recovery Pathway for Endoscopy

NCT04983498 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STU00214245
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhanced Recovery Pathway; Endoscopy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• To compare patient satisfaction scores before and after implementing a modified ERAs for endoscopy patients in the recovery period.

  15 minutes

Study Arms (2)

Prospective Experimental Group

EXPERIMENTAL

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

Retrospective Control Group

NO INTERVENTION

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.

Interventions

Ondansetron 4 MG DRUG

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

Prospective Experimental Group

Lactated Ringers, Intravenous DRUG

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

Also known as: Intravenous Hydration

Prospective Experimental Group

Early Mobilization OTHER

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

Prospective Experimental Group

Early PO Intake OTHER

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.

Prospective Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient colonoscopy under moderate sedation
• Colonoscopy Indications: Screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related 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.

  PMID: 19517165 BACKGROUND

• 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.

  PMID: 24255744 BACKGROUND

• 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.

  PMID: 29977464 BACKGROUND

• 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. doi: 10.1056/NEJMoa032196.

  PMID: 15190136 BACKGROUND

• 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.

  PMID: 20679780 BACKGROUND

• Crenshaw JT, Winslow EH. Preoperative fasting: old habits die hard. Am J Nurs. 2002 May;102(5):36-44; quiz 45. doi: 10.1097/00000446-200205000-00033.

  PMID: 12006853 BACKGROUND

• Gan TJ. Postoperative nausea and vomiting--can it be eliminated? JAMA. 2002 Mar 13;287(10):1233-6. doi: 10.1001/jama.287.10.1233. No abstract available.

  PMID: 11886298 BACKGROUND

• 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.

  PMID: 30594252 BACKGROUND

• 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. doi: 10.1111/j.1365-2036.2007.03406.x.

  PMID: 17697197 BACKGROUND

• 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.

  PMID: 28097305 BACKGROUND

• 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.

  PMID: 26650497 BACKGROUND

• 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. doi: 10.4103/0259-1162.179310.

  PMID: 27746521 BACKGROUND

• 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. doi: 10.1213/ANE.0000000000001617.

  PMID: 27870735 BACKGROUND

• 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.

  PMID: 24916073 BACKGROUND

MeSH Terms

Interventions

Ondansetron; Ringer's Lactate; Early Ambulation

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Angela Maeder, PhD

  Northwestern Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RNC-OB, Clinical Nurse, Labor and Delivery Northwestern Memorial Hospital

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 30, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)