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

Not Applicable

Completed

• Conditions: Knee Surgery; Pelvic Surgery; Spinal Aneshtesia
• Interventions: Drug: Dexmedetomidine 3 mcg; Drug: Dexmedetomidine 4 mcg; Drug: Dexmedetomidine 5 mcg; Drug: Dexmedetomidine 6 mcg; Drug: Bupivacain hyperbaric 0.5% 12.5 mg

• Registration Number: NCT07144215
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31
• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-20
• Study First Posted: 2025-08-27
• Last Update Submitted: 2025-08-29
• Last Update Posted: 2025-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine 3 mcg	Dexmedetomidine 3 mcg	Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 3 mcg.
Dexmedetomidine 3 mcg	Bupivacain hyperbaric 0.5% 12.5 mg	Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 3 mcg.
Dexmedetomidine 4 mcg	Dexmedetomidine 4 mcg	Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 4 mcg.
Dexmedetomidine 4 mcg	Bupivacain hyperbaric 0.5% 12.5 mg	Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 4 mcg.
Dexmedetomidine 5 mcg	Dexmedetomidine 5 mcg	Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 5 mcg.
Dexmedetomidine 5 mcg	Bupivacain hyperbaric 0.5% 12.5 mg	Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 5 mcg.
Dexmedetomidine 6 mcg	Dexmedetomidine 6 mcg	Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 6 mcg.
Dexmedetomidine 6 mcg	Bupivacain hyperbaric 0.5% 12.5 mg	Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 6 mcg.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Effective Sensory Blockade (≥200 Minutes)	Until the end of the surgery	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.

Secondary Outcome Measures

Name	Time	Method
Hypotension Incidence	At the start of surgery until the end of surgery	Whether the patient experienced drop in blood pressure (systolic, diastolic, and mean arterial pressure) \> 20% from base value.
Bradycardia Incidence	Until the end of surgery	Whether patient experienced drop in heart rate to \<50 beat per minute.
Nausea Incidence	Until the end of surgery	Whether patient experienced persistent nausea that cause vomiting.

Trial Locations

Locations (1)

RSUPN Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, Jakarta Special Capital Region, Indonesia