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CompletedNCT05693246Updated May 8, 2026

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

An interventional study of Glycopyrrolate and normal saline in Glycopyrrolate, sponsored by Zhuan Zhang. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Zhuan Zhang · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glycopyrrolate

Keywords

  • Glycopyrrolate
  • Oxygenation
  • Pulmonary function
  • Lung compliance
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Glycopyrrolate

    Drug: Glycopyrrolate

  • Placebo comparator
    Control

    Other: normal saline

Interventions

  • DrugGlycopyrrolate

    At 10 minutes after endotracheal intubation, the Glycopyrrolate group was injected intravenously with 0.006mg/kg glycopyrrolate.

  • Othernormal saline

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

05

What researchers measure

Primary outcomes

  1. the oxygenation index

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

    Time frame: at the end of surgery

Secondary outcomes

  1. the oxygenation index

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

    Time frame: 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

  2. dynamic lung compliance

    Time frame: 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

  3. the alveolar-arterial oxygen gradient

    Time frame: 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

  4. clara cell secretory protein 16 (CC16)

    Time frame: Baseline (prior to the induction of general anesthesia), and at the end of surgery

  5. transforming growth factor-β1 (TGF-β1)

    Time frame: Baseline (prior to the induction of general anesthesia), and at the end of surgery

06

Study locations

1 site
  • the Affiliated Hospital of Yangzhou University, Yangzhou University
    Yangzhou, Jiangsu, China
07

Registry details

Key details

Study ID
NCT05693246
Lead sponsor
Zhuan Zhang
Responsible party
Zhuan Zhang (Principal Investigator, Yangzhou University) — Sponsor-investigator
First posted
Jan 20, 2023
Start date
Oct 1, 2023
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024
Last update
May 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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