Perioperative Nutrition
Conditions
Keywords
Nil Per Os (NPO), stomach volume, gastric volume, Aspiration
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.
Interventions
OTHERClear Liquids
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
OTHERStandard of Care
Participants will not take anything my mouth after midnight day before surgery
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * Prisoner * Procedures conducted on weekends and holidays * Emergency or non-elective procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual Gastric Volume in mL/kg | At time of intubation (about 1 hour after fluid intake) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 observed emesis | During perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours) | — |
| Number of participants with intraoperative complications | From start of surgery to end of surgery | — |
| Amount of post-operative pain medications needed | at first clinic 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 wound dehiscence | postoperative follow up appointment (about 1 month after surgery) | — |
Countries
United States
Outcome results
None listed