CClinicalTrials.gg
CompletedNCT07144215Updated Sep 5, 2025

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

An interventional study of Dexmedetomidine 3 mcg and Dexmedetomidine 4 mcg in Knee Surgery, Pelvic Surgery and Spinal Aneshtesia, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2025, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Surgery
  • Pelvic Surgery
  • Spinal Aneshtesia
03

In context

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Dexmedetomidine 3 mcg

    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

  • Experimental
    Dexmedetomidine 4 mcg

    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

  • Experimental
    Dexmedetomidine 5 mcg

    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

  • Experimental
    Dexmedetomidine 6 mcg

    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

  • DrugDexmedetomidine 3 mcg

    Patient received spinal injection of dexmedetomidine 3 mcg.

  • DrugDexmedetomidine 4 mcg

    Patient received spinal injection of dexmedetomidine 4 mcg.

  • DrugDexmedetomidine 5 mcg

    Patient received spinal injection of dexmedetomidine 5 mcg.

  • DrugDexmedetomidine 6 mcg

    Patient received spinal injection of dexmedetomidine 6 mcg.

  • DrugBupivacain hyperbaric 0.5% 12.5 mg

    Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg

06

What researchers measure

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.

    Time frame: Until the end of the surgery

Secondary outcomes

  1. 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

  2. Bradycardia Incidence

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

    Time frame: Until the end of surgery

  3. Nausea Incidence

    Whether patient experienced persistent nausea that cause vomiting.

    Time frame: Until the end of surgery

07

Study locations

1 site
  • RSUPN Cipto Mangunkusumo
    Jakarta Pusat, Jakarta Special Capital Region 10430, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07144215
Lead sponsor
Indonesia University
Responsible party
Raden Besthadi Sukmono (Anesthesiologist, Indonesia University) — Principal investigator
First posted
Aug 27, 2025
Start date
Feb 1, 2025
Primary completion
May 31, 2025
Completion
May 31, 2025
Last update
Sep 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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