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

NCT05693246 | Completed

• 1 other identifier: 20221202
• Study Type: interventional
• Target: 52
• 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 objective of this study was to evaluate the effect of glycopyrrolate on oxygenation index in elderly patients undergoing radical surgery for gastrointestinal malignant tumor.

Conditions

Glycopyrrolate

Keywords

Glycopyrrolate; Oxygenation; Pulmonary function; Lung compliance

Outcome Measures

Primary Outcomes (1)

• the oxygenation index

  the oxygenation index(PaO₂ / FiO₂) is calculated and recorded accordingly.

  at the end of surgery

Secondary Outcomes (5)

• the oxygenation index

  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

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 0.006mg/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+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Location

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

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, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

CN (1)