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

The University of Texas Health Science Center, Houston

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Conditions

Perioperative Nutrition

Interventions

Clear LiquidsOTHER

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

Standard of CareOTHER

Participants will not take anything my mouth after midnight day before surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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

Time frame: During perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)

Number of participants with subjective pre-operative nausea

Time frame: at baseline

Number of participants with subjective post-operative nausea

Time frame: within 24 hours of surgery

Number of participants with production of oropharyngeal secretions

Time frame: During the perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)

Number of participants with wound dehiscence

Time frame: postoperative follow up appointment (about 1 month after surgery)

Number of participants with intraoperative complications

Time frame: From start of surgery to end of surgery

Amount of post-operative pain medications needed

Time frame: 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

Time frame: within 48-96 hours of surgery

Data from ClinicalTrials.gov

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