Knee SurgeryNCT07144215
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
A study testing Dexmedetomidine 3 mcg, Dexmedetomidine 4 mcg and Dexmedetomidine 5 mcg in people with Knee Surgery and Pelvic Surgery, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Surgery, Pelvic Surgery, Spinal Aneshtesia
- What is being tested?
- Dexmedetomidine 3 mcg, Dexmedetomidine 4 mcg and Dexmedetomidine 5 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
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
- Being tested
- Dexmedetomidine 3 mcg, Dexmedetomidine 4 mcg, Dexmedetomidine 5 mcg, Dexmedetomidine 6 mcg, Bupivacain hyperbaric 0.5% 12.5 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Dexmedetomidine 6 mcgDrug
Patient received spinal injection of dexmedetomidine 6 mcg.
Bupivacain hyperbaric 0.5% 12.5 mgDrug
Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 3 mcg | Experimental | Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 3 mcg. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Dexmedetomidine 6 mcg; Drug: Bupivacain hyperbaric 0.5% 12.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until the end of the surgery
Secondary outcomes (3)
Hypotension Incidence
Whether the patient experienced drop in blood pressure (systolic, diastolic, and mean arterial pressure) > 20% from base value.
Measured: At the start of surgery until the end of surgery
Bradycardia Incidence
Whether patient experienced drop in heart rate to <50 beat per minute.
Measured: Until the end of surgery
Nausea Incidence
Whether patient experienced persistent nausea that cause vomiting.
Measured: Until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Feb 2025
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee SurgeryStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raden Besthadi Sukmono, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144215
- Sponsor's protocol ID
- ED50DEXMEDETOMIDINE
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07144215
- Acronym / sponsor ID
- ED50DEXMEDETOMIDINE
- Conditions
- Knee Surgery, Pelvic Surgery, Spinal Aneshtesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 3 mcg | Experimental | Drug: Dexmedetomidine 3 mcg, Drug: Bupivacain hyperbaric 0.5% 12.5 mgPatient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 3 mcg. |
| Dexmedetomidine 4 mcg | Experimental | Drug: Dexmedetomidine 4 mcg, Drug: Bupivacain hyperbaric 0.5% 12.5 mgPatient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 4 mcg. |
| Dexmedetomidine 5 mcg | Experimental | Drug: Dexmedetomidine 5 mcg, Drug: Bupivacain hyperbaric 0.5% 12.5 mgPatient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 5 mcg. |
| Dexmedetomidine 6 mcg | Experimental | Drug: Dexmedetomidine 6 mcg, Drug: Bupivacain hyperbaric 0.5% 12.5 mgPatient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 6 mcg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine 3 mcgPatient received spinal injection of dexmedetomidine 3 mcg. | Drug | Dexmedetomidine 3 mcg |
| Dexmedetomidine 4 mcgPatient received spinal injection of dexmedetomidine 4 mcg. | Drug | Dexmedetomidine 4 mcg |
| Dexmedetomidine 5 mcgPatient received spinal injection of dexmedetomidine 5 mcg. | Drug | Dexmedetomidine 5 mcg |
| Dexmedetomidine 6 mcgPatient received spinal injection of dexmedetomidine 6 mcg. | Drug | Dexmedetomidine 6 mcg |
| Bupivacain hyperbaric 0.5% 12.5 mgPatient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg | Drug | Dexmedetomidine 3 mcg, Dexmedetomidine 4 mcg, Dexmedetomidine 5 mcg, Dexmedetomidine 6 mcg |
Primary outcome
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.
3 secondary outcomes
Hypotension Incidence
Time frame: At the start of surgery until the end of surgery
Bradycardia Incidence
Time frame: Until the end of surgery
Nausea Incidence
Time frame: Until the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine 3 mcg, Dexmedetomidine 4 mcg and Dexmedetomidine 5 mcg in people with Knee Surgery and Pelvic Surgery, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Effective Sensory Blockade (≥200 Minutes) (time frame: Until the end of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.