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NCT Number: NCT04142502

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

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.

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Key information

Conditions

Spinal Anesthesia Autonomic Nervous System

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Propofol as a sedation drug

Other names: FRESofol MCT inj 1% 500mg/50ml, Fresenium Kabi

Dexmedetomidin

Drug

Dexmedetomidine as a sedation drug

Other names: Medex inj, 200mcg/2ml, ILSUNG

Primary outcomes

  1. Serial heart rate variability

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Collaborators

  • Ilsung Pharmaceuticals CO.,LTD.

Registry information

Official study title

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

Acronym: ANS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2019
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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