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

NCT07144215 | Completed

• 1 other identifier: ED50DEXMEDETOMIDINE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Surgery; Pelvic Surgery; Spinal Aneshtesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Until the end of the surgery

Secondary Outcomes (3)

• Hypotension Incidence

  At the start of surgery until the end of surgery

• Bradycardia Incidence

  Until the end of surgery

• Nausea Incidence

  Until the end of surgery

Study Arms (4)

Dexmedetomidine 3 mcg

EXPERIMENTAL

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 3 mcg.

Drug: Dexmedetomidine 3 mcg; Drug: Bupivacain hyperbaric 0.5% 12.5 mg

Dexmedetomidine 4 mcg

EXPERIMENTAL

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 4 mcg.

Drug: Dexmedetomidine 4 mcg; Drug: Bupivacain hyperbaric 0.5% 12.5 mg

Dexmedetomidine 5 mcg

EXPERIMENTAL

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 5 mcg.

Drug: Dexmedetomidine 5 mcg; Drug: Bupivacain hyperbaric 0.5% 12.5 mg

Dexmedetomidine 6 mcg

EXPERIMENTAL

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 6 mcg.

Drug: Dexmedetomidine 6 mcg; Drug: Bupivacain hyperbaric 0.5% 12.5 mg

Interventions

Dexmedetomidine 3 mcg DRUG

Patient received spinal injection of dexmedetomidine 3 mcg.

Dexmedetomidine 3 mcg

Dexmedetomidine 4 mcg DRUG

Patient received spinal injection of dexmedetomidine 4 mcg.

Dexmedetomidine 4 mcg

Dexmedetomidine 5 mcg DRUG

Patient received spinal injection of dexmedetomidine 5 mcg.

Dexmedetomidine 5 mcg

Dexmedetomidine 6 mcg DRUG

Patient received spinal injection of dexmedetomidine 6 mcg.

Dexmedetomidine 6 mcg

Bupivacain hyperbaric 0.5% 12.5 mg DRUG

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg

Dexmedetomidine 3 mcg; Dexmedetomidine 4 mcg; Dexmedetomidine 5 mcg; Dexmedetomidine 6 mcg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUPN Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: February 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)