Effect of Perioperative Use of Glycopyrrolate on Lung Function in Patients Under General Anesthesia

Study Overview
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Brief Summary
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Gastrointestinal tumor is one of the highest incidence of malignant tumors in our country, with the incidence increasing year by year. Laparoscopic gastrointestinal surgery ,due to having less bleeding ,small trauma ,Rapid recovery ,has become the main means for the treatment of gastrointestinal surgery. Under general anesthesia, mechanical ventilation can lead to repeated mechanical dilation of alveoli, which can lead to mechanical injury of alveolar epithelium, reduce lung compliance, affect lung function, and increase postoperative complications and hospital stay of patients. Glycopyrrolate acts selectively on M1 and M3 receptors, and is 3-5 times more selective to M3 and M1 receptors than M2 receptors. Therefore, as preoperative medication for elderly patients, it has less effect on the cardiovascular system and can stabilize the heart rate,compared with atropine.However, its influence on the respiratory system in the field of anesthesia is only limited to the study of inhibiting glandular secretion at present, and there are no clear reports on the study of respiratory mechanics .The purpose of this study was to investigate the effects of glycopyrrolate on lung function and respiratory mechanics in elderly patients after general anesthesia, in order to guide clinical medication.

Official Title
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Effect of Perioperative Use of Glycopyrrolate on Lung Function in Patients Under General Anesthesia

Conditions
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Glycopyrrolate

Intervention / Treatment
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* Drug: Glycopyrrolate
* Other: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly patients undergoing elective laparoscopic radical gastrectomy; ASA Grade I-III; BMI 18 to 30 kg /㎡； Operation time≥2 hours. Exclusion Criteria: Hypersensitivity to glycopyrrolate； Clinical diagnosis of hepatic and renal insufficiency； Complicated myasthenia gravis； Prolonged QT interval and other abnormal electrocardiogram； History of mechanical ventilation within six months before surgery； Combined with glaucoma； The patient refused.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glycopyrrolate<br> | Drug: Glycopyrrolate<br>* At 10 minutes after endotracheal intubation, the Glycopyrrolate group was injected intravenously with 0.004mg/kg glycopyrrolate.<br>|
| Placebo Comparator: Control<br> | Other: normal saline<br>* At 10 minutes after endotracheal intubation, the Control group was intravenously injected with equal dose of normal saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes in lung compliance | Lung compliance refers to the degree to which the lungs change under external forces | 10 minutes after intubation; 10 minutes after pneumoperitoneum; 1 hour after pneumoperitoneum; End of pneumoperitoneum for 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes in oxygenation index | Oxygenation index is an important indicator of lung function | 10 minutes after intubation; 10 minutes after pneumoperitoneum; 1 hour after pneumoperitoneum; End of pneumoperitoneum for 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycopyrrolate, Perioperative period, Lung compliance