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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04142502
Acronym
ANS
Enrollment
60
Registered
2019-10-29
Start date
2020-01-20
Completion date
2021-12-31
Last updated
2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia, Autonomic Nervous System

Keywords

spinal anesthesia, autonomic nervous system, dexmedetomidine, propofol

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.

Interventions

Dexmedetomidine as a sedation drug

DRUGPropofol

Propofol as a sedation drug

Sponsors

Ilsung Pharmaceuticals CO.,LTD.
CollaboratorUNKNOWN
Ajou University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serial heart rate variability40 minutes (before entering the operating room ~ 20 minutes after starting sedationSerial 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026