NCT04554589

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Effect of Drugs

Interventions

Type	Name	Description
DRUG	Glycopyrrolate 0.2 MG	injections
DRUG	normal saline	normal saline

Timeline

• Start date: 2020-09-14
• Primary completion: 2021-02-10
• Completion: 2021-04-10
• First posted: 2020-09-18
• Last updated: 2020-09-23

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated drug study