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

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Perioperative Nutrition

Treatments: Other: Standard of Care; Other: Clear Liquids

Study type: Interventional

Funder types: Other

Identifiers

NCT06216977

HSC-MS-23-0868

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Clear Liquids Arm

Experimental group

Treatment:

Other: Clear Liquids

Standard Of Care

Active Comparator group

Treatment:

Other: Standard of Care