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OpenTrials
Completed

NCT Number: NCT07144215

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

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.

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Key information

Conditions

Knee Surgery Pelvic Surgery Spinal Aneshtesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUPN Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine 3 mcg

Drug

Patient received spinal injection of dexmedetomidine 3 mcg.

Dexmedetomidine 4 mcg

Drug

Patient received spinal injection of dexmedetomidine 4 mcg.

Dexmedetomidine 5 mcg

Drug

Patient received spinal injection of dexmedetomidine 5 mcg.

Dexmedetomidine 6 mcg

Drug

Patient received spinal injection of dexmedetomidine 6 mcg.

Bupivacain hyperbaric 0.5% 12.5 mg

Drug

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg

Primary outcomes

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

    Time frame: 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 outcomes

  1. Hypotension Incidence

    Time frame: 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.

  2. Bradycardia Incidence

    Time frame: Until the end of surgery

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

  3. Nausea Incidence

    Time frame: Until the end of surgery

    Whether patient experienced persistent nausea that cause vomiting.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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