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

NCT ID: NCT05693246

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-03-30

Brief Summary

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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 purpose of this study was to investigate the effects of glycopyrrolate on lung function and respiratory mechanics in elderly patients after general anesthesia, in order to guide clinical medication.

Detailed Description

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Conditions

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Glycopyrrolate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Glycopyrrolate

Group Type EXPERIMENTAL

Glycopyrrolate

Intervention Type DRUG

At 10 minutes after endotracheal intubation, the Glycopyrrolate group was injected intravenously with 0.004mg/kg glycopyrrolate.

Control

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

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

Interventions

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Glycopyrrolate

At 10 minutes after endotracheal intubation, the Glycopyrrolate group was injected intravenously with 0.004mg/kg glycopyrrolate.

Intervention Type DRUG

normal saline

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Elderly patients undergoing elective laparoscopic radical surgery for gastrointestinal malignant tumors;
2. ASA Grade I-III;
3. BMI 18 to 30 kg /㎡;
4. Operation time≥2 hours.

Exclusion Criteria

1. Hypersensitivity to glycopyrrolate;
2. Clinical diagnosis of hepatic and renal insufficiency;
3. Complicated myasthenia gravis;
4. Prolonged QT interval and other abnormal electrocardiogram;
5. History of mechanical ventilation within six months before surgery;
6. Combined with glaucoma;
7. The patient refused.
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhuan Zhang

OTHER

Sponsor Role lead

Responsible Party

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Zhuan Zhang

:: Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zhuan zhang, professor

Role: CONTACT

+8615062791355

Facility Contacts

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Zhuan Zhang, professor

Role: primary

+8615062791355 ext. +8615062791355

Other Identifiers

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20221202

Identifier Type: -

Identifier Source: org_study_id

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