Clears On the Day of Anesthesia Permissible up to One-Hour Prior (CODA-POP) to Surgery

CODA-POP Surgery: Clears On the Day of Anesthesia Permissible up to One-Hour Prior to Surgery - A Prospective Randomized and Blind Trial

The purpose of this study is to assess whether residual gastric volumes in patients who receive clear liquids one hour prior to time of procedure is non-inferior compared to patients who are NPO past midnight, to compare efficiency and flexibility of operating room scheduling between two fasting conditions, to assess patient satisfaction and post-operative nausea, vomiting, pain, hunger and thirst.

and to assess wound healing and post-operative complication rates.

Study Overview

• Status: Withdrawn
• Conditions: Perioperative Nutrition
• Intervention / Treatment: Other: Clear Liquids; Other: Standard of Care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergoing laparoscopic cholecystectomy during the day or night of a weekday (including those consented on a Friday who get postponed to a weekend surgery start time).
• Modified rapid sequence intubation (mRSI)

Exclusion Criteria:

• History of reflux disease
• History of hiatal hernia
• History of esophageal disease
• History of gastroparesis
• Known history of difficult airway or planned fiberoptic intubation
• HbA1c greater than 12
• Pregnant women
• Prisoner
• Procedures conducted on weekends and holidays
• Emergency or non-elective procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clear Liquids Arm	Other: Clear Liquids; Participants will not take anything by mouth after midnight the day before surgery but will be given 12 ounce clear liquid (Sugar-free Gatorade) at bedside at the pre-operative holding area
Active Comparator: Standard Of Care	Other: Standard of Care; Participants will not take anything my mouth after midnight day before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Residual Gastric Volume in mL/kg	At time of intubation (about 1 hour after fluid intake)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with observed emesis		During perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)
Number of participants with subjective pre-operative nausea		at baseline
Number of participants with subjective post-operative nausea		within 24 hours of surgery
Number of participants with production of oropharyngeal secretions		During the perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)
Number of participants with wound dehiscence		postoperative follow up appointment (about 1 month after surgery)
Number of participants with intraoperative complications		From start of surgery to end of surgery
Amount of post-operative pain medications needed		at first clinic appointment (about 1 month after surgery)
Overall patient satisfaction as assessed by the Press-Ganey Questionnaire	This is a 10 item questionnaire and each is scored from 1(very poor) to 5(very good) , maximum score of 50 a higher number indicating better outcome	within 48-96 hours of surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: George Williams, MD, FASA, FCCM, FCCP, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2024
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Aspiration; stomach volume; gastric volume; Nil Per Os (NPO)
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: HSC-MS-23-0868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No