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OpenTrials
Completed

NCT Number: NCT06237478

Effects of Glycopyrrolate on Heart Rate and Heart Rate Variability in Patients With Different Basic Heart Rate

Glycopyrrolate is an anticholinergic medication commonly used in respiratory medicine for treating chronic obstructive pulmonary disease (COPD), bronchial asthma, and other conditions . In the perioperative period, it is often administered before anesthesia to reduce secretions in the salivary glands, bronchi, and pharynx . It is used during the recovery period to counteract the muscarinic effects of anticholinesterase inhibitors and can also be employed to prevent/treat vagal reflexes and related arrhythmias induced by surgery or medications .

Heart rate (HR) is influenced by both the sympathetic and parasympathetic nervous systems. The baseline HR of different patients may vary due to differing levels of sympathetic and parasympathetic nerve activity within the body. It remains unclear whether patients with different baseline HRs exhibit varying degrees of HR elevation after the administration of glycopyrrolate(i.e.,the parasympathetic activity in vivo is antagonized). The primary aim of this study is to explore the impact of glycopyrrolate administration on HR in patients with different baseline HRs. The secondary objective is to investigate the effects of glycopyrrolate on heart rate variability (HRV) in patients with different baseline HR.

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Key information

Conditions

Age range

18 year–65 year

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

  • 1.Weight not restricted; 2.American Society of Anesthesiologists (ASA) status I or II; 3.The operative time≥1 h; 4.Undergoing orthopedic or urological surgery.

Exclusion criteria

  • 1.allergy to glycopyrrolate; 2.laparoscopic surgery; 3.liver or kidney dysfunction; 4.pre-existing abnormal electrocardiogram such as bradycardia; 5.concomitant glaucoma; 6.patients refusal to participate.

Treatment and study plan

Glycopyrrolate

Drug

At the timepoint of 10 min after operation beginning (T1), the basic HR, MAP and the HRV frequency indexes were recorded. Then glycopyrrolate 0.006 mg/kg was injected intravenously in Group L.

Primary outcomes

  1. The maximum increase of HR

    Time frame: before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection

    Calculation of the maximum increase of HR (∆HR): The increase in heart rate (HR) at 30 minutes after the administration of glycopyrrolate (T2) compared to 10 minutes after the start of surgery (T1) was calculated as the maximum increase of HR.

  2. the maximum increase ratio of HR

    Time frame: before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection

    The maximum increase ratio of HR =∆HR/[HR at T1]) .

Secondary outcomes

  1. HRV frequency indexes

    Time frame: before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection

    HRV frequency indexes included Low frequency power (LF, 0.04-0.15 Hz), High frequency power (HF, 0.15-0.4 Hz) and LF/HF.

Sponsors and collaborators

Lead sponsor

Zhuan Zhang

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

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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