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.

Study Overview

• Status: Completed
• Conditions: Glycopyrrolate
• Intervention / Treatment: Drug: Glycopyrrolate; Drug: Glycopyrrolate

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group L; 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.	Drug: Glycopyrrolate; 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.; Drug: Glycopyrrolate; 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.
Experimental: Group H; 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.	Drug: Glycopyrrolate; 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.; Drug: Glycopyrrolate; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum increase of HR	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.	before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection
the maximum increase ratio of HR	The maximum increase ratio of HR =∆HR/[HR at T1]) .	before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HRV frequency indexes	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.	before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection

Collaborators and Investigators

• Sponsor: Zhuan Zhang

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Autonomic nervous system; Heart rate variability; Heart rate; Glycopyrrolate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: 20240123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No