Preventive Effects of Penehyclidine Hydrochloride Inhalation on Postoperative Pulmonary Complications

NCT02644876 | Completed Phase 4 DMC

• 2 other identifiers: 2015[06]ChiCTR-IPC-15006603
• 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, but not M2 receptors. A pilot study of the investigators showed that prophylactic penehyclidine inhalation reduced the incidence of bronchospasm and the use of aminophylline in elderly patients after long-duration surgery. The purpose of this study is to investigate whether prophylactically penehyclidine inhalation could decrease the incidence of PPCs in high-risk patients after major intrathoracic and upper intraabdominal surgery.

Conditions

Postoperative Complications

Keywords

Postoperative pulmonary complications; Selective anticholinergic bronchodilator; High risk patients; Postoperative period; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative pulmonary complications (PPCs)

  PPCs indicate complications that occur in the respiratory system from end of surgery till 30 days after surgery and require therapeutic intervention. Items include respiratory failure, respiratory infection, atelectasis, pleural effusion, bronchospasm, pneumothorax and aspiration pneumonitis.

  Up to 30 days after surgery

Secondary Outcomes (5)

• Time to onset of PPCs

  From end of surgery till onset of first documented PPCs or death from any cause, whichever came first, assessed up to 30 days

• Number of PPCs

  Up to 30 days after surgery

• Incidence of extrapulmonary complications

  Up to 30 days after surgery

• Length of stay (LOS) in hospital after surgery

  Up to 30 days after surgery

• All-cause 30-day mortality

  Up to 30 days after surgery

Study Arms (2)

Penehyclidine group

EXPERIMENTAL

Penehyclidine inhalation will be 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 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: Penehyclidine inhalation

Control group

PLACEBO COMPARATOR

Placebo inhalation will be 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 will be 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.

Also known as: Penehyclidine Hydrochloride for Injection (Changtuoning)

Penehyclidine group

Placebo inhalation DRUG

Placebo inhalation will be 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 oxygen-driven method for the non-intubated patients or with the atomizing inhalation device of ventilator for the intubated patients.

Also known as: Water for injection

Control group

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>50 years;
• Scheduled to undergo upper abdominal or noncardiac thoracic surgery with expected duration ≥2 hours. For those who undergo laparoscopic or thoracoscopic surgery, the expected length of incision must be ≥5 cm;
• Judged to be 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 hours;
• Preoperative history of symptomatic 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)

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (19)

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  PMID: 29183393 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Injections; Water

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hopital

  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: December 30, 2015
• First Posted: January 1, 2016
• Study Start: September 1, 2015
• Primary Completion: November 8, 2018
• Study Completion: December 10, 2018
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)