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

Glycopyrrolate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05693246
• Other study ID #: 20221202
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: January 2024
• Source: Yangzhou University
• Contact: zhuan zhang, professor
• Phone: +8615062791355
• Email: zhangzhuancg[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glycopyrrolate

Intervention

Drug:
• Glycopyrrolate
At 10 minutes after endotracheal intubation, the Glycopyrrolate group was injected intravenously with 0.004mg/kg glycopyrrolate.

Other:
• normal saline
At 10 minutes after endotracheal intubation, the Control group was intravenously injected with equal dose of normal saline.

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhuan Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the changes in systolic blood pressure	Record changes in systolic blood pressure	10 minutes after intubation;10 minutes after pneumoperitoneum; 1 hour after pneumoperitoneum; End of pneumoperitoneum for 10 minutes
Primary	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	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