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Arthropathy of KneePhase 4NCT04307290

Dexmedetomidine on Tourniquet Induced -Systemic Effects

A Phase 4 study testing Dexmedetomidine Hydrochloride, or Saline in people with Arthropathy of Knee and Spinal Anesthesia, run by Wonkwang University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Eighty patients were randomly assigned to either control (CON) or dexmedetomidine (DEX) group. DEX group received a loading dose of 0.5 µg/ kg of intravenous dexmedetomidine over 10 minutes, followed by a continuous infusion of 0.5 µg/kg/h until completion of the surgery. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Arthropathy of Knee, Spinal Anesthesia, Tourniquet
What is being tested?
Dexmedetomidine Hydrochloride, or Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteSouth Korea
Study dates
3 Feb 2020to 5 Mar 2020
Phase
Phase 4
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients aged between 20 and 80 years, American Society of Anesthesiologists (ASA) physical status class I-III, who were scheduled to undergo elective TKA

Who cannot join

  • Patients with history of rheumatoid arthritis, diabetes mellitus, hepatic or renal disease, allergy to drug being studied, heart block greater than first degree, left ventricle ejection fraction < 55%, or chronic administration of anti-inflammatory drugs, or opioids were excluded. Patients with tourniquet times of less than 60 minutes or longer than 150 minutes or with conversion to general anesthesia during surgery

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • WonwangUH

    Iksan, Jeollabuk-do, 570-711

Other trials in South Korea

About this study

Official title: The Impact of Dexmedetomidine on Tourniquet Induced -Systemic Effects in Total Knee Arthroplasty Under Spinal Anesthesia-prospective Study.

Eighty patients were randomly assigned to either control (CON) or dexmedetomidine (DEX) group. DEX group received a loading dose of 0.5 µg/ kg of intravenous dexmedetomidine over 10 minutes, followed by a continuous infusion of 0.5 µg/kg/h until completion of the surgery. CON group received the same calculated volume of normal saline. Pain outcomes, metabolic and coagulative changes after tourniquet application, and after tourniquet release were investigated.

Read the detailed description

A total of 80 patients aged between 20 and 80 years, American Society of Anesthesiologists (ASA) physical status class I-III, who were scheduled to undergo elective TKA were enrolled in this study. Patients with history of rheumatoid arthritis, diabetes mellitus, hepatic or renal disease, allergy to drug being studied, heart block greater than first degree, left ventricle ejection fraction < 55%, or chronic administration of anti-inflammatory drugs, or opioids were excluded. Patients with tourniquet times of less than 60 minutes or longer than 150 minutes or with conversion to general anesthesia during surgery were also excluded.

Randomization Randomization sequence was created using Stata 9.0 (Stata Corp, College Station, TX, USA) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 4. Assignments were concealed in sealed envelopes. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups: DEX group (n = 40) received intravenous dexmedetomidine (0.5 μg/kg bolus over 10 minutes, followed by 0.5 μg/kg/h infusion from 10 min before the start of surgery to the end of surgery), and CON group (n = 40) received an equivalent volume of normal saline bolus and infusion as placebo until the end of surgery.

Patients, attending anesthesiologists responsible for patient care, and nurses were all blinded to the anesthetic agent during the study period.

Anesthesia and perioperative care Standard monitoring included electrocardiography, noninvasive arterial blood pressure monitoring, and pulse oximetry. All patients received spinal anesthesia performed by an attending anesthesiologist and 500 mL Ringer's lactate solution was administered for hydration before spinal anesthesia.

Spinal anesthesia was performed in the lateral decubitus position with the operative knee uppermost. These patients received an intrathecal injection of 0.5% bupivacaine 15 mg in 5% glucose at the level of L4-5 via using a 25-gauge needle. Patients were then turned to the supine position and the level of sensory block evaluated by pinprick.

Peak level of sensory block, sensory dermatome at tourniquet pain, time between tourniquet application and onset of pain, and tourniquet pain were performed by an independent researcher at 5, 10, 15 and 20 min after the spinal injection and then at 10-minutes intervals until the complete resolution of the sensory block.

The affected extremity in all patients was exsanguinated with an Esmarch bandage, and a tourniquet was applied at a pressure of 300 mmHg during surgery.

When a poorly localized, diffuse pain is felt by the patient at variable times after tourniquet inflation, despite adequate sensory blockade during surgery, it was considered to be induced by the tourniquet if it was unrelated to the surgical field, described as tourniquet pain in the affected extremity. Supplemental analgesia with intravenous fentanyl 100 μg was to be administered if any patient experienced tourniquet pain at any time during the procedure. General anesthesia would be induced if intravenous fentanyl supplementation was insufficient. The need for supplemental intravenous fentanyl and any conversion to general anesthesia were recorded.

When intraoperative bleeding occurred, volume replacement with Ringer's lactate solution was managed according to the decision of an attending anesthesiologist instead of blood products.

Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) and heart rate (HR) were monitored every five minutes until the end of surgery.

Hypotension was defined as a 30% reduction of basal MAP, which was treated with ephedrine 5 mg iv. When the HR was <50 beats/minute (bradycardia), glycopyrrolate 0.2 mg was administered intravenously.

Before the start of surgery, femoral nerve block to reduce postoperative pain were performed using a bolus of 20 mL of ropivacaine 0.75%. Concurrently, patient-controlled analgesia (PCA) pump containing fentanyl 1000 μg, ketorolac 150 mg, and ramosetron 0.6 mg in a total volume of 150 mL of saline was set to deliver a basal infusion of 2 mL/h and bolus doses of 1 mL, with a 15-min lockout period for postoperative analgesia. PCA volume consumed at 24 and 48 hours after surgery and total PCA volume consumed for 48 hr after surgery. Postoperative pain intensity at rest was measured using a 100 mm linear visual analog scale (VAS). The VAS score for pain at rest was measured at 24 and 48 hours after surgery.

Fentanyl 100 μg was administered for a pain VAS ≥ 50 or ketorolac 30 mg was given for a pain VAS < 50 or upon patient request.

Measurements of metabolic, coagulative and temperature changes. The arterial blood samples were obtained from a radial artery at 1 minute just before the start of spinal anesthesia as a baseline and at 10 min after tourniquet release.

5 mL of blood samples were extracted through radial artery and then 1 mL were collected in the heparinized syringe; following this, the remaining blood samples were immediately sent through the pneumatic tube system, guaranteeing their processing in the least amount of time possible, not greater than 5 minutes by institutional standards. The metabolic variables included pH, lactate, calcium, potassium, bicarbonate, CO2, base excess and coagulative change included antithrombin III activity.

Tympanic temperature measurements were made using Braun Thermoscan (Thermoscan Inc., San Diego, CA) inserted into the auditory canal at 1 minute just before the start of spinal anesthesia as a baseline and at 10 minutes after tourniquet release

Being tested
Dexmedetomidine Hydrochloride, or Saline
Medical subject headings
Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine Hydrochloride, or SalineDrug

    Also called precedex

    drug infusion from 10 min before the start of surgery to the end of surgery

Study groups in NCT04307290
Study groupRoleWhat they receive
DEX groupExperimentalreceived intravenous dexmedetomidine (0.5 μg/kg bolus over 10 minutes, followed by 0.5 μg/kg/h infusion from 10 min before the start of surgery to the end of surgery
Receives: Drug: Dexmedetomidine Hydrochloride, or Saline
CON groupPlacebo comparatorreceived an equivalent volume of normal saline bolus and infusion as placebo until the end of surgery.
Receives: Drug: Dexmedetomidine Hydrochloride, or Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total PCA volume consumed

    patient-controlled analgesia (PCA) pump containing fentanyl 1000 μg, ketorolac 150 mg, and ramosetron 0.6 mg in a total volume of 150 mL of saline was set to deliver a basal infusion of 2 mL/h and bolus doses of 1 mL, with a 15-min lockout period for postoperative analgesia.

    Measured: for 48 hours after surgery

Secondary outcomes (5)
  1. hemodynamic variable

    Systolic blood pressure ((mmHg)), diastolic blood pressure ((mmHg)), mean arterial blood pressure ((mmHg)) were monitored every five minutes until the end of surgery.

    Measured: baseline, 10 min, 30 min, 60min after tourniquet application and 10 min after tourniquet release

  2. heart rate (hemodynamic variable)

    heart rate (beats/min) was monitored every five minutes until the end of surgery.

    Measured: baseline, 10 min, 30 min, 60min after tourniquet application and 10 min after tourniquet release

  3. Number of participants with metabolic variables

    5 mL of blood samples were extracted through radial artery and then 1 mL were collected in the heparinized syringe; following this, the remaining blood samples were immediately sent through the pneumatic tube system, guaranteeing their processing in the least amount of time possible, not greater than 5 minutes by institutional standards. The metabolic variables included pH, lactate(Mm/L), calcium(mg/dl), potassium(mEq/L), bicarbonate(Mm/L), CO2(mmHg)

    Measured: baseline, 10 min after tourniquet release

  4. coagulative variable

    coagulative change included antithrombin III activity (%).

    Measured: baseline, 10 min after tourniquet release

  5. body temperature

    Tympanic temperature measurements were made using Braun Thermoscan inserted into the auditory canal

    Measured: at 1 min just before the start of spinal anesthesia as a baseline and at 10 min after tourniquet release.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2020
  2. Study start3 Feb 2020
  3. Primary completion10 Feb 2020
  4. Study completion5 Mar 2020

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
dexmedetomidine (0.5 μg/kg bolus over 10 minutes, followed by 0.5 μg/kg/h infusion from 10 min before the start of surgery to the end of surgery), and CON group (n = 40) received an equivalent volume of normal saline bolus and infusion as placebo until the end of surgery.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04307290
Sponsor's protocol ID
WonkwangUH6
Status last verified
Mar 2020
First submitted
9 Mar 2020
Last updated
13 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine Hydrochloride, or Saline in people with Arthropathy of Knee and Spinal Anesthesia, run by Wonkwang University Hospital at 1 site in South Korea.

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 1 inclusion and 1 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 13 Mar 2020. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

total PCA volume consumed (time frame: for 48 hours after 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 13 Mar 2020.

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