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

NCT06237478 | Completed

• 1 other identifier: 20240123
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glycopyrrolate

Keywords

Glycopyrrolate; Heart rate; Heart rate variability; Autonomic nervous system

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• HRV frequency indexes

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

Study Arms (2)

Group L

EXPERIMENTAL

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

Group H

EXPERIMENTAL

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

Interventions

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.

Group L

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Location

MeSH Terms

Interventions

Glycopyrrolate

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: March 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

CN (1)