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

Ajou University School of Medicine

Status: Completed

Conditions: Spinal Anesthesia; Autonomic Nervous System

Treatments: Drug: Dexmedetomidin; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04142502

MED-INT-19-350

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Propofol group

Active Comparator group

Description:

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

Treatment:

Drug: Propofol

Dexmedetomidine group

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidin