Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia

Spinal Anesthesia Clinical Trial

— ANS  

Official title:

Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142502
• Other study ID #: MED-INT-19-350
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases parasympathetic activity and increases sympathetic activity. These imbalance of autonomic nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which are used for sedation during spinal anesthesia, also affect autonomic nervous system, but the exact effects are not well known. The purpose of this study is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia.

Description:

Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases parasympathetic activity and increases sympathetic activity. These imbalance of autonomic nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which are used for sedation during spinal anesthesia, also affect autonomic nervous system but the exact effects are not well known. Moreoever, the effect of spinal anesthesia combined with sedation agent on autonomic nervous system has not been evaluated. The purpose of this study is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia. The current study is prospective randomized pilot study. Patients are assigned to propofol group and dexmedetomidine group. Using electrocardiaogram analysis, the change of autonomic nervous system will be measured from preoperative to end of surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• age 20~60 years old

• Scheduled lower extremity surgery under spinal anesthesia

Exclusion Criteria:

• Arryhthmia

• Uncooperative patients

• Diabetes

• On medication: beta blocker, psychiatric medicine

• Thyroid function abnormality

Related Conditions & MeSH terms

• Autonomic Nervous System
• Spinal Anesthesia

Intervention

Drug:
• Propofol
Propofol as a sedation drug
• Dexmedetomidin
Dexmedetomidine as a sedation drug

Locations

Country	Name	City	State
Korea, Republic of	Ajou university school of medicine	Suwon	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Ajou University School of Medicine	Ilsung Pharmaceuticals CO.,LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serial heart rate variability	Serial change of frequency domain results from EKG RR interval Baseline: before entering the operating room T0: Preinduction T1: 10 minutes after spinal anesthesia T2: 10 minutes after starting sedation T3: 20 minutes after starting sedationi; Frequency domain results Total power (ms2) Low frequency (ms2) High frequency (ms2) LF/HF ratio	40 minutes (before entering the operating room ~ 20 minutes after starting sedation