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Completed

NCT Number: NCT05693246

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

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Glycopyrrolate

Drug

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

Normal Saline

Other

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

Primary outcomes

  1. the oxygenation index

    Time frame: at the end of surgery

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

Secondary outcomes

  1. the oxygenation index

    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

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

  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

Sponsors and collaborators

Lead sponsor

Zhuan Zhang

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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