Ignite Creation Date:
2024-05-06 @ 12:50 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03868709
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2019-03-03
Brief Title:
Prophylactic Penehyclidine Hydrochloride Inhalation and 3-year Outcome After Surgery
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Impact of Prophylactic Penehyclidine Hydrochloride Inhalation on Long-term Outcome in High-risk Patients 3-year Follow-up of a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postoperative pulmonary complications PPCs are major causes of postoperative morbidity mortality and prolonged hospital stayThe 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
Detailed Description:
Postoperative pulmonary complications PPCs are major causes of postoperative morbidity mortality and prolonged hospital stay The incidence of PPCs was found to vary from 2 to 19 but this rate may be as high as 41 to 75 in patients after intrathoracic and intraabdominal surgery According to Canets model the predicted incidence of PPCs in high-risk patients ARISCAT risk index 45 points is 421
Use of effective strategies to prevent PPCs is essential for those high-risk patients As a bronchodilator anticholinergic inhalation may be helpful Studies showed that in high-risk patients undergoing intrathoracic surgery airway resistance is increased due to bronchial hyperresponsiveness which increased the risk of PPCs Inhalation of anticholinergic bronchodilator can reduce the activity of vagus nerve and relieve high airway resistance which may decrease the risk of bronchospasm and other PPCs It has been shown that M1 M3-receptor selective blockers have better effects than β2-receptor activator in dilating bronchia
Penehyclidine hydrochloride is a new anticholinergic agent which selectively blocks M1 and M3 receptors Preclinical studies found that it also has anti-inflammation effects In a pilot study of the investigators prophylactic inhalation of penehyclidine decreased the incidence of bronchospasm and the use of aminophylline in elderly patients after long-duration surgery In a previous randomized controlled trial 864 high-risk patients were recruited and randomized to receive prophylactic inhalation of either penehyclidine or placebo
The investigators hypothesize that prophylactically penehyclidine hydrochloride inhalation may improve long-term outcomes in this patient population by reducing PPCs The purpose of this 3-year follow-up study is to investigate whether prophylactically penehyclidine hydrochloride inhalation can affect the 3-year outcomes in high-risk patients recruited in the previous randomized controlled trial
Use of effective strategies to prevent PPCs is essential for those high-risk patients As a bronchodilator anticholinergic inhalation may be helpful Studies showed that in high-risk patients undergoing intrathoracic surgery airway resistance is increased due to bronchial hyperresponsiveness which increased the risk of PPCs Inhalation of anticholinergic bronchodilator can reduce the activity of vagus nerve and relieve high airway resistance which may decrease the risk of bronchospasm and other PPCs It has been shown that M1 M3-receptor selective blockers have better effects than β2-receptor activator in dilating bronchia
Penehyclidine hydrochloride is a new anticholinergic agent which selectively blocks M1 and M3 receptors Preclinical studies found that it also has anti-inflammation effects In a pilot study of the investigators prophylactic inhalation of penehyclidine decreased the incidence of bronchospasm and the use of aminophylline in elderly patients after long-duration surgery In a previous randomized controlled trial 864 high-risk patients were recruited and randomized to receive prophylactic inhalation of either penehyclidine or placebo
The investigators hypothesize that prophylactically penehyclidine hydrochloride inhalation may improve long-term outcomes in this patient population by reducing PPCs The purpose of this 3-year follow-up study is to investigate whether prophylactically penehyclidine hydrochloride inhalation can affect the 3-year outcomes in high-risk patients recruited in the previous randomized controlled trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None