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

NCT05693246 | Unknown

• 1 other identifier: 20221202
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Glycopyrrolate

Keywords

Glycopyrrolate; Perioperative period; Lung compliance; Autonomic nervous system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the changes in oxygenation index

  10 minutes after intubation; 10 minutes after pneumoperitoneum; 1 hour after pneumoperitoneum; End of pneumoperitoneum for 10 minutes

Other Outcomes (1)

• the changes in systolic blood pressure

  10 minutes after intubation;10 minutes after pneumoperitoneum; 1 hour after pneumoperitoneum; End of pneumoperitoneum for 10 minutes

Study Arms (2)

Glycopyrrolate

EXPERIMENTAL

Drug: Glycopyrrolate

Control

PLACEBO COMPARATOR

Other: normal saline

Interventions

Glycopyrrolate DRUG

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

Glycopyrrolate

normal saline OTHER

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

Control

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

Glycopyrrolate; Saline Solution

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

zhuan zhang, professor

CONTACT

+8615062791355; zhangzhuancg@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: :: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: January 20, 2023
• Study Start: October 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

CN (1)