Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial

The Guthrie Clinic

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Conditions

C.Surgical Procedure; Digestive System

Interventions

CaffeineDIETARY_SUPPLEMENT

caffeinated gum

GumOTHER

Chewing gum

wear silicone braceletBEHAVIORAL

Subjects will put on bracelet to correspond with times for chewing gum

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Guthrie Clinic

Sayre, Pennsylvania, United States

Outcomes

Primary Outcomes

Mean time to GI function recovery (GI-3)

Time frame: An expected average of 5 days

Secondary Outcomes

Mean length of postoperative hospitalization

Time frame: Up to 30 days

Rate of postoperative ileus

Time frame: Up to 30 days

Adverse event rates

Time frame: Up to 30 days postoperative

Data from ClinicalTrials.gov

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