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

NCT06216977 | Withdrawn

• 1 other identifier: HSC-MS-23-0868
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perioperative Nutrition

Keywords

Nil Per Os (NPO); stomach volume; gastric volume; Aspiration

Outcome Measures

Primary Outcomes (1)

• Residual Gastric Volume in mL/kg

  At time of intubation (about 1 hour after fluid intake)

Secondary Outcomes (8)

• 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)

Study Arms (2)

Clear Liquids Arm

EXPERIMENTAL

Other: Clear Liquids

Standard Of Care

ACTIVE COMPARATOR

Other: Standard of Care

Interventions

Clear Liquids OTHER

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

Clear Liquids Arm

Standard of Care OTHER

Participants will not take anything my mouth after midnight day before surgery

Standard Of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• George Williams, MD, FASA, FCCM, FCCP

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: January 20, 2024
• Primary Completion: May 30, 2024
• Study Completion: July 1, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)