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

Effect of Perioperative Use of Glycopyrrolate on Lung Function in Elderly Patients Undergoing Laparoscopic Surgery For Gastrointestinal Cancer

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 objective of this study was to evaluate the effect of glycopyrrolate on oxygenation index in elderly patients undergoing radical surgery for gastrointestinal malignant tumor.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China
      • the Affiliated Hospital of Yangzhou University, Yangzhou University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. aged 65 yrs or elder;
2. gender unlimited;
3. American Society of Anesthesiologists (ASA) class I to III;
4. an expected surgical duration of at least 2 hrs.

Exclusion Criteria:

1. refusal to participate;
2. known allergy to glycopyrrolate;
3. severe hepatic or renal insufficiency;
4. myasthenia gravis;
5. angle-closure glaucoma;
6. tachycardia detected on the preoperative electrocardiogram (ECG);
7. contraindications to epidural anesthesia;
8. a history of mechanical ventilation within the past six months;
9. severe respiratory disease or restricted thoracic mobility such as thoracic deformity.

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 0.006mg/kg glycopyrrolate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the oxygenation index	the oxygenation index(PaO₂ / FiO₂) is calculated and recorded accordingly.	at the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the oxygenation index	the oxygenation index(PaO₂ / FiO₂) is calculated and recorded accordingly.	immediately before the intravenous administration of glycopyrrolate or normal saline, 10 minutes after the establishment of CO2 pneumoperitoneum, and 1 hour after the initiation of CO2 pneumoperitoneum
dynamic lung compliance		immediately before the intravenous administration of glycopyrrolate or normal saline, 10 minutes after the establishment of CO₂ pneumoperitoneum, 1 hour after the initiation of CO₂ pneumoperitoneum, and at the end of surgery
the alveolar-arterial oxygen gradient		immediately before the intravenous administration of glycopyrrolate or normal saline, 10 minutes after the establishment of CO₂ pneumoperitoneum, 1 hour after the initiation of CO₂ pneumoperitoneum, and at the end of surgery
clara cell secretory protein 16 (CC16)		Baseline (prior to the induction of general anesthesia), and at the end of surgery
transforming growth factor-β1 (TGF-β1)		Baseline (prior to the induction of general anesthesia), and at the end of surgery

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, 2023
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): July 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): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pulmonary function; Oxygenation; Glycopyrrolate; Lung compliance
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Glycopyrrolate; Saline Solution
• 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