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

NCT ID: NCT04142502

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2021-12-31

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.

Conditions

Spinal Anesthesia; Autonomic Nervous System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Propofol group

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

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol as a sedation drug

Dexmedetomidine group

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidin

Intervention Type: DRUG

Dexmedetomidine as a sedation drug

Interventions

Propofol

Propofol as a sedation drug

Intervention Type: DRUG

Dexmedetomidin

Dexmedetomidine as a sedation drug

Intervention Type: DRUG

Other Intervention Names

FRESofol MCT inj 1% 500mg/50ml, Fresenium Kabi; Medex inj, 200mcg/2ml, ILSUNG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ilsung Pharmaceuticals CO.,LTD.

UNKNOWN

Sponsor Role: collaborator

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

In-kyong Yi

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In Kyong Yi, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

Ajou university school of medicine

Suwon, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

MED-INT-19-350

Identifier Type: -

Identifier Source: org_study_id