Clinical trial NCT06216977: Clears On the Day of Anesthesia Permissible up to One-Hour Prior (CODA-POP) to Surgery
Official title: CODA-POP Surgery: Clears On the Day of Anesthesia Permissible up to One-Hour Prior to Surgery - A Prospective Randomized and Blind Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perioperative Nutrition
Keywords: Nil Per Os (NPO)
stomach volume
gastric volume
Aspiration
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Residual Gastric Volume in mL/kg
timeFrame: At time of intubation (about 1 hour after fluid intake)
Secondary outcomes:
measure: Number of participants with observed emesis
timeFrame: During perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)
measure: Number of participants with subjective pre-operative nausea
timeFrame: at baseline
measure: Number of participants with subjective post-operative nausea
timeFrame: within 24 hours of surgery
measure: Number of participants with production of oropharyngeal secretions
timeFrame: During the perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)
measure: Number of participants with wound dehiscence
timeFrame: postoperative follow up appointment (about 1 month after surgery)
measure: Number of participants with intraoperative complications
timeFrame: From start of surgery to end of surgery
measure: Amount of post-operative pain medications needed
timeFrame: at first clinic appointment (about 1 month after surgery)
measure: Overall patient satisfaction as assessed by the Press-Ganey Questionnaire
timeFrame: within 48-96 hours of surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: George Williams, MD, FASA, FCCM, FCCP
role: PRINCIPAL_INVESTIGATOR
References: