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PI passed away
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clear Liquids Arm | Experimental |
| |
| Standard Of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clear Liquids | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Gastric Volume in mL/kg | At time of intubation (about 1 hour after fluid intake) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with observed emesis | During perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours) | |
| Number of participants with subjective pre-operative nausea | at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Williams, MD, FASA, FCCM, FCCP | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Participants will not take anything my mouth after midnight day before surgery |
|
| 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 wound dehiscence | postoperative follow up appointment (about 1 month after surgery) |
| 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 | 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 | within 48-96 hours of surgery |