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

Not Applicable

Not yet recruiting

• Conditions: Perioperative Nutrition
• Interventions: Other: Clear Liquids; Other: Standard of Care

• Registration Number: NCT06216977
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study Start: 2024-01-20
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-05-30
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clear Liquids Arm	Clear Liquids	-
Standard Of Care	Standard of Care	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
Overall patient satisfaction as assessed by the Press-Ganey Questionnaire	within 48-96 hours of surgery	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
Number of participants with intraoperative complications	From start of surgery to end of surgery
Number of participants with subjective pre-operative nausea	at baseline
Number of participants with subjective post-operative nausea	within 24 hours of surgery
Amount of post-operative pain medications needed	at first clinic appointment (about 1 month after surgery)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States