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

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.

Study Overview

• Status: Recruiting
• Conditions: Glycopyrrolate
• Intervention / Treatment: Drug: Glycopyrrolate; Other: normal saline

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: zhuan zhang, professor; Phone Number: +8615062791355; Email: zhangzhuancg@163.com

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China
      • Recruiting
      • the Affiliated Hospital of Yangzhou University, Yangzhou University
      • Contact: Zhuan Zhang, professor; Phone Number: +8615062791355 +8615062791355; Email: zhangzhuancg@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhuan Zhang

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: December 3, 2022
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Autonomic nervous system; Glycopyrrolate; Lung compliance; Perioperative period
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: 20221202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No