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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05693246
Enrollment
52
Registered
2023-01-20
Start date
2023-10-01
Completion date
2024-07-30
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycopyrrolate

Keywords

Glycopyrrolate, Oxygenation, Pulmonary function, Lung compliance

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.

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.

Sponsors

Zhuan Zhang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

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.

Design outcomes

Primary

MeasureTime frameDescription
the oxygenation indexat the end of surgerythe oxygenation index(PaO₂ / FiO₂) is calculated and recorded accordingly.

Secondary

MeasureTime frameDescription
the oxygenation indeximmediately 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 pneumoperitoneumthe oxygenation index(PaO₂ / FiO₂) is calculated and recorded accordingly.
dynamic lung complianceimmediately 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 gradientimmediately 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026