The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.

Tanta University

Status and phase: Unknown; Phase 1

Conditions: Effect of Drugs

Treatments: Drug: normal saline; Drug: Glycopyrrolate 0.2 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04554589

0000-0002-141

Details and patient eligibility

About

Tracheostomized patients in the ICU can have excessive tracheal secretions due to various causes as hyperactive airway, irritation of the mucus producing cells and inhibition of the ciliary functions. Excessive secretions will necessitate frequent suctions which carries the risk of tracheostomy tube obstruction if not managed properly. Excessive tracheal secretions may prolong the ICU stay, increase the nurses workload and increase patients morbidity and mortality.

This clinical trial hypothesizes that the use of glycopyrrolate may decrease the tracheal secretions and hence avoid such complications.

Full description

Patients fulfilling the inclusion criteria will be randomly assigned into one of 2 groups:

Group G (Intervention group): Patients will receive Glycopyrrolate 0.2 mg IV every 8 hours.

Group C (Control group): Patients will receive 2 mL Normal saline every 8 hours.

Both injections will be labelled as drug A and drug B in the satellite pharmacy .

Both the attending physician, nurse and data collector will be blinded to the injection given.

Measurements data will be collected and recorded daily in the pre-prepared CRF during the study period.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients above 18 years old.
2. Patients who are admitted to ICU for more than 72 hours.
3. Patients who have tracheostomy tubes with reported frequent need for suction of the tracheostomy tube secretions more than once every 4 hours.

Exclusion criteria

1. Patients who have evidence of lower respiratory tract infections and have positive cultures from the tracheal aspirate.
2. Patients who have known sensitivity to Glycopyrrolate.
3. Patients who have tachycardia (heart rate above 120 Beats/minute) or known to have tachyarrhythmiase.g atrial fibrillation.
4. Patients with mitral stenosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

intervention group

Active Comparator group

Description:

receive Glycopyrrolate at dose of 0.2 mg IV every 8 hours daily .

Treatment:

Drug: Glycopyrrolate 0.2 MG

placebo group

Placebo Comparator group

Description:

receive normal saline 2 ml IV every 8 hours daily .

Treatment:

Drug: normal saline