ED50 of Dexmedetomidine as an Adjuvant to 0.5% Hyperbaric Bupivacaine 12.5 mg for Spinal Anesthesia in Hip and Knee Surgery: An Up-and-Down Method Approach

Indonesia University40 enrolled

Overview

Determine ED50 dexmedetomidine adjuvant that can provide spinal anesthetic sensory blockade duration of 200 minutes on knee and pelvis surgery with up-and-down method.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Knee Surgery Pelvic Surgery Spinal Aneshtesia

Interventions

Dexmedetomidine 3 mcgDRUG

Patient received spinal injection of dexmedetomidine 3 mcg.

Dexmedetomidine 4 mcgDRUG

Patient received spinal injection of dexmedetomidine 4 mcg.

Dexmedetomidine 5 mcgDRUG

Patient received spinal injection of dexmedetomidine 5 mcg.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18-60 years old * Pelvic or knee surgery patient with American Society of Anesthesiologists physical status I - III with epidural spinal anesthesia * Body mass index 18-35 kg/m2 * Body height 150-180 cm * Willing to become a research participant Exclusion Criteria: * Have a history of allergy to bupivacaine or dexmedetomidine * Have sensory or motoric disabilities in the lower extremity contralateral to the surgery area * Have a history of congestive heart failure and/or heart rhythm disorder * Have regional anesthesia contraindication

Locations (1)

RSUPN Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Outcomes

Primary Outcomes

Number of Participants With Effective Sensory Blockade (≥200 Minutes)

Effectiveness is defined as a sensory blockade duration of at least 200 minutes from administration of spinal anesthesia with adjuvant dexmedetomidine to regression of sensory level to the T12 dermatome. Participants with blockade duration \<200 minutes will be considered not effective.

Time frame: Until the end of the surgery

Secondary Outcomes

Hypotension Incidence

Whether the patient experienced drop in blood pressure (systolic, diastolic, and mean arterial pressure) \> 20% from base value.

Time frame: At the start of surgery until the end of surgery

Bradycardia Incidence

Whether patient experienced drop in heart rate to \<50 beat per minute.

Time frame: Until the end of surgery

Nausea Incidence

Whether patient experienced persistent nausea that cause vomiting.

Time frame: Until the end of surgery

Data from ClinicalTrials.gov

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