CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 864 enrolled
Drug / intervention
Penehyclidine inhalation +1 moredrug
Likely dose
Penehyclidine inhalation 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03868709
NCT03868709Phase 4Completed
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Impact of Prophylactic Penehyclidine Hydrochloride Inhalation on Long-term Outcome in High-risk Patients: 3-year Follow-up of a Randomized Controlled Trial

Peking University First Hospital·interventional·Posted Mar 11, 2019·Updated Apr 16, 2025

In Brief

A Phase 4 clinical trial evaluating Penehyclidine inhalation and Placebo inhalation for Postoperative Complications and Long-term Outcome. Completed, enrolled 864 participants across 1 site.

Detailed Summary

Postoperative pulmonary complications (PPCs) are major causes of postoperative morbidity, mortality, and prolonged hospital stay.The incidence of PPCs may be as high as 41% to 75% in high-risk patients. Bronchodilator is frequently used in high-risk patients to prevent PPCs. Penehyclidine is a new anticholinergic agent which selectively block M1 and M3 receptors. A previous randomized controlled trial tested the effect of prophylactic penehyclidine inhalation on the incidence of PPCs in high-risk patients. The purpose of this 3-year follow-up study is to investigate whether prophylactically penehyclidine hydrochloride inhalation can affect the 3-year outcomes of patients recruited in the previous randomized controlled trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Complications, Long-term Outcome
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMar 11, 2019
Enrollment StartMar 12, 2019
Primary CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.3 years ago

Interventions

Penehyclidine inhalationdrug

Penehyclidine inhalation is administered by inhalation (penehyclidine hydrochloride 0.5 mg/0.5 ml, mixed with normal saline 5.5 ml) once every 12 hours from the night before surgery till the second day after surgery. The total number of inhalation is seven times. Study drug inhalation is performed with the high-flow oxygen-driven method for the non-intubated patients or with the atomizing inhalation device of ventilator for the intubated patients

Placebo inhalationdrug

Placebo inhalation is administered by inhalation (water for injection 0.5 ml, mixed with normal saline 5.5 ml) once every 12 hours from the night before surgery till the second day after surgery. The total number of inhalation is seven times. Study drug inhalation is performed with the high-flow oxygendriven method for the non-intubated patients or with the atomizing inhalation device of ventilator for the intubated patients.