Prophylactic Penehyclidine Hydrochloride Inhalation and 3-year Outcome After Surgery

NCT03868709 | Completed Phase 4

• 1 other identifier: 2018[213]
• Study Type: interventional
• Target: 864
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complications; Long-term Outcome

Keywords

Postoperative pulmonary complications; Penehyclidine Hydrochloride; High risk patients; Postoperative period; Long-term outcome

Outcome Measures

Primary Outcomes (1)

• Duration of overall survival within 3 years after surgery

  Duration of overall survival within 3 years after surgery

  From the day of surgery until the end of the 3rd year after surgery

Secondary Outcomes (6)

• Survival rates at different timepoints after surgery

  At the end of the 1st, 2nd, and 3rd year after surgery

• Duration of recurrence-free survival within 3 years after surgery

  From the day of surgery until the end of the 3rd year after surgery

• Ocurrence of new-onset diseases during the 3-year period after surgery

  From the day of surgery until the end of the 3rd year after surgery

• Cognitive function of 3-year survivors

  Assessed at the end of the 3rd year after surgery

• The quality of life in 3-year survivors

  Assessed at the end of the 3rd year after surgery

Study Arms (2)

Penehyclidine group

EXPERIMENTAL

Penehyclidine inhalation is administered (penehyclidine hydrochloride 0.5 mg/0.5 ml + 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.

Drug: Penehyclidine inhalation

Placebo group

PLACEBO COMPARATOR

Placebo inhalation is administered by inhalation (water for injection 0.5 ml + 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 will be 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.

Drug: Placebo inhalation

Interventions

Penehyclidine inhalation DRUG

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

Penehyclidine group

Placebo inhalation DRUG

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.

Placebo group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 50 years or over;
• Scheduled to undergo open or laparoscope assisted upper abdominal or intrathoracic surgery;
• The expected duration of surgery is 2 hours or longer;
• Identified at high risk of PPCs according to the ARISCAT risk score (ARISCAT predictive score ≥45).

You may not qualify if:

• American Society of Anesthesiologists (ASA) physical classification ≥ IV or the expected survival duration ≤ 24 h;
• Preoperative history of prostatic hypertrophy or glaucoma;
• History of myocardial infarction, severe heart dysfunction (New York Heart Association functional classification ≥ 3) or tachyarrhythmia within one year;
• Inhalation of β2-receptor activator, M-receptor blockers and/or glucocorticoids within one month before surgery;
• Severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (Child-Pugh grade C);
• History of acute stroke within three months before surgery;
• Refuse to participate in the study or unable to cooperate with the inhalation therapy;
• Participation in other clinical trial during the last month or within the six half-life periods of the study drug used in the last trial.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (19)

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MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 11, 2019
• Study Start: March 12, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)