NCT06216977WithdrawnNot Applicable
CODA-POP Surgery: Clears On the Day of Anesthesia Permissible up to One-Hour Prior to Surgery - A Prospective Randomized and Blind Trial
The University of Texas Health Science Center, Houston2 sites in 1 country150 target enrollmentStarted: January 20, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Residual Gastric Volume in mL/kg
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Procedures conducted on weekends and holidays
- •Emergency or non-elective procedures
Outcomes
Primary Outcomes
Residual Gastric Volume in mL/kg
Time Frame: At time of intubation (about 1 hour after fluid intake)
Secondary Outcomes
- Number of participants with observed emesis(During perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours))
- 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 subjective post-operative nausea(within 24 hours of surgery)
- Overall patient satisfaction as assessed by the Press-Ganey Questionnaire(within 48-96 hours of surgery)
- Number of participants with intraoperative complications(From start of surgery to end of surgery)
- Number of participants with subjective pre-operative nausea(at baseline)
- Amount of post-operative pain medications needed(at first clinic appointment (about 1 month after surgery))
Investigators
yafen liang
Professor
The University of Texas Health Science Center, Houston
Study Sites (2)
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