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

NCT04142502 | Completed

• 1 other identifier: MED-INT-19-350
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia; Autonomic Nervous System

Keywords

spinal anesthesia; autonomic nervous system; dexmedetomidine; propofol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Propofol group

ACTIVE COMPARATOR

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

Drug: Propofol

Dexmedetomidine group

ACTIVE COMPARATOR

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

Drug: Dexmedetomidin

Interventions

Propofol DRUG

Propofol as a sedation drug

Also known as: FRESofol MCT inj 1% 500mg/50ml, Fresenium Kabi

Propofol group

Dexmedetomidin DRUG

Dexmedetomidine as a sedation drug

Also known as: Medex inj, 200mcg/2ml, ILSUNG

Dexmedetomidine group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• Ilsung Pharmaceuticals CO.,LTD.: collaborator

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Interventions

Propofol; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• In Kyong Yi, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Propofol group: propofol infusion as sedation drug Dexmedetomidine group: dexmedetomidine infusion as sedation drug

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: January 20, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)