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

NCT06237478 — Not applicable, Completed, 54 participants, Zhuan Zhang

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Registry	NCT06237478
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: triple, prevention
Enrollment	54 (Actual)
Sponsor	Zhuan Zhang (Other)
Conditions	Glycopyrrolate
Interventions	Glycopyrrolate (Drug)
Dates	start 2023-03-01, primary completion 2023-06-30, completion 2023-06-30, first posted 2024-02-01, last updated 2024-02-01
Locations	1 site in China

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Group L	Experimental	Drug: Glycopyrrolate	The HR at 10 minutes after the start of surgery was considered as the baseline HR. Patients were divided into two groups based on their baseline HR: Group L: Baseline HR 40-60 beats/min.
Group H	Experimental	Drug: Glycopyrrolate	The HR at 10 minutes after the start of surgery was considered as the baseline HR. Patients were divided into two groups based on their baseline HR: Group H: Baseline HR 60-100 beats/min.

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.
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 H.

+Outcome measures

Primary outcomes

The maximum increase of HR [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.
the maximum increase ratio of HR [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

HRV frequency indexes [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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou, Jiangsu	China

My Notes

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