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

Glycopyrrolate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06237478
• Other study ID #: 20240123
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glycopyrrolate

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhuan Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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