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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-20

Study Completion Date

2024-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Perioperative Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Clear Liquids Arm

Group Type EXPERIMENTAL

Clear Liquids

Intervention Type 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

Standard Of Care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

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

Interventions

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Clear 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

Intervention Type OTHER

Standard of Care

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No