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The effect of penehyclidine hydrochloride on postoperative pulmonary complications: A multicenter prospective randomized double-blind controlled clinical trial

The effect of penehyclidine hydrochloride on postoperative pulmonary complications: A multicenter prospective randomized double-blind controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077508
Enrollment
Unknown
Registered
2023-11-10
Start date
2023-11-13
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Postoperative pulmonary complications

Interventions

Experimental group (Group P) :Experimental group (group P) : 10min before anesthesia induction, intravenous injection of penehyclidine hydrochloride 0.005mg/kg (diluted to 5ml with normal saline), and
control group (Group C):Control group (Group C) : The same volume of normal saline was given intravenously.

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1)Age >50 years old, ASA Grade II or III; 2)BMI=18.5kg/m2 ; 3)Non-cardiothoracic surgery is expected to take more than 2 hours; 4)According to the ARISCAT risk score, the cumulative ARISCAT score is =26; 5)Subjects agree to participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients who are unable to communicate pre-operatively due to neurocognitive dysfunction or language impairment; 2)Patients with unstable angina pectoris, myocardial infarction and heart failure within 3 months; 3)Patients requiring ventilator support or oxygen before surgery; 4)Patients with any cerebrovascular accident within 3 months, such as stroke, transient ischemic attack (TIA), etc; 5)Patients with severe liver dysfunction: Child-Pugh grade C; Patients with severe renal dysfunction: glomerular clearance 10 days within six months and have immune system disorders; 8)Patients with a history of major surgery within 1 month before the trial; 9)Patients with a history of major surgery within 1 month before the trial; 10)Patients with contraindications or allergies to experimental drugs and other narcotic drugs.

Design outcomes

Primary

MeasureTime frame
Incidence of pulmonary complications within 7 days (including 7 days) after surgery;

Secondary

MeasureTime frame
Pulmonary ultrasound score: before anesthesia, 48h after surgery, 7d after surgery;CC-16, IL-8, TNF-a, CRP: before administration (T0), 60min after administration (T60), after surgery (Tend), 24h after surgery (T24h);Incidence of delirium 24h, 48h, 72h, and 7d after surgery;Incidence of nausea and vomiting at 24h, 48h and 72h after surgery;Pain score difference at 24h, 48h and 72h after surgery;Postoperative dry mouth, diplopia adverse reactions: 24h, 48h, 72h after surgery;

Countries

China

Contacts

Public ContactYang Jian-Jun

The First Afliated Hospital of Zhengzhou University

jianjunyang1971@163.com+86 137 8353 7619

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026