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

May 4, 2026 updated by: Zhuan Zhang

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China
        • the Affiliated Hospital of Yangzhou University, Yangzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
Other: normal saline
At 10 minutes after endotracheal intubation, the Control group was intravenously injected with equal dose of normal saline.
Experimental: Glycopyrrolate
Drug: Glycopyrrolate
At 10 minutes after endotracheal intubation, the Glycopyrrolate group was injected intravenously with 0.006mg/kg glycopyrrolate.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the oxygenation index
Time Frame: at the end of surgery
the oxygenation index(PaO₂ / FiO₂) is calculated and recorded accordingly.
at the end of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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
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
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
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)
Time Frame: Baseline (prior to the induction of general anesthesia), and at the end of surgery
Baseline (prior to the induction of general anesthesia), and at the end of surgery
transforming growth factor-β1 (TGF-β1)
Time Frame: Baseline (prior to the induction of general anesthesia), and at the end of surgery
Baseline (prior to the induction of general anesthesia), and at the end of surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the changes in systolic blood pressure
Time Frame: 10 minutes after intubation;10 minutes after pneumoperitoneum; 1 hour after pneumoperitoneum; End of pneumoperitoneum for 10 minutes
Record changes in systolic blood pressure
10 minutes after intubation;10 minutes after pneumoperitoneum; 1 hour after pneumoperitoneum; End of pneumoperitoneum for 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhuan Zhang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20221202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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