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

Not Applicable

Completed

• Conditions: Spinal Anesthesia; Autonomic Nervous System
• Interventions: Drug: Propofol; Drug: Dexmedetomidin

• Registration Number: NCT04142502
• Lead Sponsor: Ajou University School of Medicine

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Study Start: 2020-01-20
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age 20~60 years old
• Scheduled lower extremity surgery under spinal anesthesia

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Exclusion Criteria

• Arryhthmia
• Uncooperative patients
• Diabetes
• On medication: beta blocker, psychiatric medicine
• Thyroid function abnormality

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol group	Propofol	Using propofol as a sedation drug Infusion rate control Effect site concentration 0.3\~1.0 mg/ml using target concentration infusion Bispectral index 60\~80
Dexmedetomidine group	Dexmedetomidin	Using dexmedetomidine as a sedation drug First 10 minutes 1.0 mcg/kg loading After 10 minutes 0.3-1.0 mcg/kg/hr maintenance Bispectral index 60\~80

Primary Outcome Measures

Name	Time	Method
Serial heart rate variability	40 minutes (before entering the operating room ~ 20 minutes after starting sedation	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

Trial Locations

Locations (1)

Ajou university school of medicine; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of