C.Surgical Procedure; Digestive System
Conditions
Brief summary
This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure. Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times daily for 30 minutes starting the day following surgery until discharge or 24 hours after attainment of the primary endpoint.
Interventions
DIETARY_SUPPLEMENTCaffeine
caffeinated gum
OTHERGum
Chewing gum
BEHAVIORALwear silicone bracelet
Subjects will put on bracelet to correspond with times for chewing gum
Sponsors
The Guthrie Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Abdominal procedure (Laparoscopic or open, occurring electively), American Society of Anesthesiologists (ASA) physical status score ≤ 3, Glasgow Coma Score (GCS) ≥ 15.
Exclusion criteria
* ASA physical status score of \>3, GCS \< 15, complete bowel obstruction, history of cardiac arrhythmia, history of phenylketonuria, alcohol abuse. substance abuse dentures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean time to GI function recovery (GI-3) | An expected average of 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Mean length of postoperative hospitalization | Up to 30 days |
| Rate of postoperative ileus | Up to 30 days |
| Adverse event rates | Up to 30 days postoperative |
Countries
United States
Outcome results
None listed