Clinical trial NCT05693246: Effect of Perioperative Use of Glycopyrrolate on Lung Function in Patients Under General Anesthesia
Official title: Effect of Perioperative Use of Glycopyrrolate on Lung Function in Patients Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glycopyrrolate
Keywords: Glycopyrrolate
Perioperative period
Lung compliance
Autonomic nervous system
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Elderly patients undergoing elective laparoscopic radical surgery for gastrointestinal malignant tumors;
2. ASA Grade I-III;
3. BMI 18 to 30 kg /㎡；
4. Operation time≥2 hours.

Exclusion Criteria:

1. Hypersensitivity to glycopyrrolate；
2. Clinical diagnosis of hepatic and renal insufficiency；
3. Complicated myasthenia gravis；
4. Prolonged QT interval and other abnormal electrocardiogram；
5. History of mechanical ventilation within six months before surgery；
6. Combined with glaucoma；
7. The patient refused.

Primary outcomes:
measure: the changes in lung compliance
timeFrame: 10 minutes after intubation; 10 minutes after pneumoperitoneum; 1 hour after pneumoperitoneum; End of pneumoperitoneum for 10 minutes
Secondary outcomes:
measure: the changes in oxygenation index
timeFrame: 10 minutes after intubation; 10 minutes after pneumoperitoneum; 1 hour after pneumoperitoneum; End of pneumoperitoneum for 10 minutes
Other outcomes:
measure: the changes in systolic blood pressure
timeFrame: 10 minutes after intubation;10 minutes after pneumoperitoneum; 1 hour after pneumoperitoneum; End of pneumoperitoneum for 10 minutes
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References: