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

The Guthrie Clinic

Status: Withdrawn

Conditions: C.Surgical Procedure; Digestive System

Treatments: Other: Gum; Dietary Supplement: Caffeine; Behavioral: wear silicone bracelet

Study type: Interventional

Funder types: Other

Identifiers

NCT02250924

GC1410-55

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.

Treatment:

Behavioral: wear silicone bracelet

Sugar-less Gum

Sham Comparator group

Description:

Subjects will chew one stick of sugar-less gum for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.

Treatment:

Other: Gum

Caffeinated Gum

Experimental group

Description:

Subjects will chew one stick of caffeinated gum (100mg caffeine per stick) for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.

Treatment:

Other: Gum

Dietary Supplement: Caffeine