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The Preventive Effect of Penehyclidine Hydrochloride Inhalation on the Incidence of Post-operative Pulmonary Complications in High-risk Patients: A Prospective, Double-blinded and Randomized Controlled Trial

The Preventive Effect of Penehyclidine Hydrochloride Inhalation on the Incidence of Post-operative Pulmonary Complications in High-risk Patients: A Prospective, Double-blinded and Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPC-15006603
Enrollment
Unknown
Registered
2015-05-14
Start date
2015-09-01
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pulmonary Complications

Interventions

Penehyclidine hydrochloride:Penehyclidine hydrochloride (penehyclidine hydrochloride 0.5 mg/0.5 ml + normal saline 5.5 ml) were administered by inhalation every 12 hours from the night before surgery
Placebo control:Placebo control (water for injection 0.5 ml+ normal saline 5.5 ml) were administered by inhalation every 12 hours from the night before surgery to the second day after surgery.

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
51 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age>50 years old; (2) Scheduled for upper abdominal surgery or thoracotomy. For those having laparo-/thoracoscopic surgery, the expected incision length was >=5 cm; (3) Expected operation time >= 2h; (4) Patients with high risk of postoperative pulmonary complications according to the Canet risk score (the Canet risk score>=45).

Exclusion criteria

Exclusion criteria: (1) patients who refuse to participate in this study or patients who cannot cooperate with the inhalation; (2) patients with ASA grade>=IV or the anticipated life time<=24h; (3) patients with prostate hypertrophy or glaucoma; (4) patients who had myocardial infarction, cardiac dysfunction or fast ventricular arrhythmia within the year; (5) patients who had been given beta 2 receptor activator, M receptor blockers and/or glucocorticoids within a month before surgery; (6) patients with serious renal dysfunction who need dialysis before the surgery; (7) patients with serious liver dysfunction (the grade of Child-Pugh C); (8) patients with cerebral stroke within three months before surgery; (9) patients who had participated in other research in the recent month or still within the six half-time of other research drugs.

Design outcomes

Primary

MeasureTime frame
Postoperative pulmonary complications;

Secondary

MeasureTime frame
Postoperative mortality of 30 days;Duration of hospital stay after surgery;Other postoperative complications;Time to onset of postoperative pulmonary complications;Number of individual pulmonary complications;

Countries

China

Contacts

Public ContactWang Dongxin

Peking University First Hospital

wangdongxin@hotmail.com+86 10 83572623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026