GlycopyrrolateNCT05693246
Effect of Perioperative Use of Glycopyrrolate on Lung Function in Patients Under General Anesthesia
A study testing Glycopyrrolate and normal saline in people with Glycopyrrolate, run by Zhuan Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Glycopyrrolate
- What is being tested?
- Glycopyrrolate and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- refusal to participate;
- known allergy to glycopyrrolate;
- severe hepatic or renal insufficiency;
- myasthenia gravis;
- angle-closure glaucoma;
- tachycardia detected on the preoperative electrocardiogram (ECG);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu
About this study
Official title: 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.
- Conditions
- Glycopyrrolate
- Being tested
- Glycopyrrolate, normal saline
- Keywords
- Glycopyrrolate, Oxygenation, Pulmonary function, Lung compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycopyrrolateDrug
At 10 minutes after endotracheal intubation, the Glycopyrrolate group was injected intravenously with 0.006mg/kg glycopyrrolate.
normal salineOther
At 10 minutes after endotracheal intubation, the Control group was intravenously injected with equal dose of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Glycopyrrolate | Experimental | Not described Receives: Drug: Glycopyrrolate |
| Control | Placebo comparator | Not described Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the oxygenation index
the oxygenation index(PaO₂ / FiO₂) is calculated and recorded accordingly.
Measured: at the end of surgery
Secondary outcomes (5)
the oxygenation index
the oxygenation index(PaO₂ / FiO₂) is calculated and recorded accordingly.
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline (prior to the induction of general anesthesia), and at the end of surgery
transforming growth factor-β1 (TGF-β1)
Measured: Baseline (prior to the induction of general anesthesia), and at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Oct 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlycopyrrolateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuan Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693246
- Sponsor's protocol ID
- 20221202
- Status last verified
- Apr 2026
- First submitted
- 3 Dec 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Use of Glycopyrrolate on Lung Function in Elderly Patients Undergoing Laparoscopic Surgery For Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT05693246
- Acronym / sponsor ID
- 20221202
- Conditions
- Glycopyrrolate
- Keywords
- Glycopyrrolate, Oxygenation, Pulmonary function, Lung compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Zhuan ZhangUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycopyrrolate | Experimental | Drug: Glycopyrrolate |
| Control | Placebo comparator | Other: normal saline |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- refusal to participate;
- known allergy to glycopyrrolate;
- severe hepatic or renal insufficiency;
- myasthenia gravis;
- angle-closure glaucoma;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlycopyrrolateAt 10 minutes after endotracheal intubation, the Glycopyrrolate group was injected intravenously with 0.006mg/kg glycopyrrolate. | Drug | Glycopyrrolate |
| normal salineAt 10 minutes after endotracheal intubation, the Control group was intravenously injected with equal dose of normal saline. | Other | Control |
Primary outcome
the oxygenation index
Time frame: at the end of surgery
the oxygenation index(PaO₂ / FiO₂) is calculated and recorded accordingly.
5 secondary outcomes
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
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
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
clara cell secretory protein 16 (CC16)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycopyrrolate and normal saline in people with Glycopyrrolate, run by Zhuan Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the oxygenation index (time frame: at the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.