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AnesthesiaPhase 3NCT05335655

IV Dexmedetomidine in the Duration of Spinal Anesthesia With Hyperbaric Bupivacaine: Double Blind Randomized Trial.

A Phase 3 study testing Dexmedetomidine injection and Sodium Chloride 0.9% infusion in people with Anesthesia and Dexmedetomidine, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Introduction: Spinal anesthesia produces sensitive and motor block according to the administered local anesthetic. The total duration of surgical anesthesia depends on the dose, intrinsic properties of the anesthetic, and the use of additional drugs. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesia, Dexmedetomidine
What is being tested?
Dexmedetomidine injection and Sodium Chloride 0.9% infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteMexico
Study dates
31 Jan 2022to 15 Jun 2022
Phase
Phase 3
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Previously accepted and signed informed consent.
  • Age between 18 and 65 years
  • Male or female
  • ASA classified I or II
  • Undergoing elective lower limb orthopedic surgery
  • Neuraxial anesthesia with 10 mg of spinal bupivacaine (2ml at 0.5%)
  • Inert epidural catheter

Who cannot join

  • Basal heart rate lower than 55 beats per minute
  • Basal mean arterial pressure (MAP) lower than 65 mmHg
  • Non-compensated heart disease
  • Sinus bradycardia
  • Drug allergy or intolerance
  • Contraindication for neuraxial blockade
Show all 12Show fewer
  • Coagulopathy
  • Lumbar structural pathology and/or vertebral instrumentation
  • Local active infection at punction site
  • Thrombocytopenia (lower than 80 K platelets)
  • Non-controlled psychiatric disease
  • Patients that receive drugs such as NSAIDs, acetaminophen and/or opioids within less than 3 hours prior to the procedure

Trial locations and contacts

1 site in 1 country.

Liliana Serrano Ibarrola, MD contact

+52 3313270064

ibarrola_92@hotmail.com

Juan Francisco Hernández Sierra, M in C contact

+52 4443082889

kiko_hdzs@hotmail.com

Mexico1 site, 1 recruiting
  • Hospital Central Dr Ignacio Morones Prieto

    San Luis Potosí City, 78210

    Liliana Serrano Ibarrola, MD, +52 3313270064, ibarrola_92@hotmail.com

    Juan Francisco Hernández Sierra, M in C, +52 4443082889

    Recruiting

Other trials in Mexico

About this study

Official title: Use of Intravenous Dexmedetomidine as an Adjuvant to Extend the Duration of Spinal Anesthesia With Hyperbaric Bupivacaine in Orthopedic Surgery in Hospital Central "Dr. Ignacio Morones Prieto": Double Blind Randomized Trial.

Introduction: Spinal anesthesia produces sensitive and motor block according to the administered local anesthetic. The total duration of surgical anesthesia depends on the dose, intrinsic properties of the anesthetic, and the use of additional drugs. Dexmedetomidine is an alpha-2 adrenergic agonist that has sedative and analgesic effects. The specific action site in the spinal cord receptors and in the locus coeruleus provide as well hypnotic and sympatholytic characteristics. The combination of spinal anesthesia and intravenous dexmedetomidine is a safe option for hemodynamically stable patients undergoing elective surgery. Material and methods: Double blind randomized trial. The objective is to time and compare the total duration of neuraxial blockade with spinal hyperbaric bupivacaine plus intravenous dexmedetomidine, against hyperbaric bupivacaine by itself. 60 patients shall be included, between the ages of 18 and 65 years, classified by the American Society of Anesthesiologists (ASA) I and II, undergoing lower limb elective orthopedic procedure, with spinal anesthesia plus epidural catheter. 50% of the patients (group A) will receive spinal hyperbaric bupivacaine and IV dexmedetomidine at 0.5 mcg/kg (real weight), and the other 50% (group B) will receive spinal hyperbaric bupivacaine plus IV 0.9% saline solution in equivalent volume.

Read the detailed description

Neuraxial blockade is produced by interrupting nervous impulse transmission with the administration of a local anesthetic. When the drug in injected directly into the subarachnoid space, it passes through the pia mater and enters the Virchow-Robin orifices all the way to the nerve ganglion of the deepest dorsal roots. This nerve endings are highly accessible and easily anesthetized, even with a low dose of local anesthetic, in comparison with the extradural nerves. The speed of the spinal blockade depends on the size, surface, and degree of myelination of the fibers exposed to the anesthetic. However, the regression or termination of the desired effect appears because of the decrease in drug concentration within the cerebrospinal fluid, which happens when the blood vessels inside the pia mater absorb the substances into the systemic circulation to be metabolized and excreted. The rate of elimination depends on the distribution of local anesthetic; while the diffusion surface is larger, the drug exposure to the vessels increases, and thus the time of action will be shorter.

Bupivacaine is one of the most used local anesthetics for spinal anesthesia, with high protein binding and a slow onset because of it relatively elevated pKa. The standard doses for clinical practice make it appropriate for surgical procedures that take 2.5 to 3 hours. The administration of complementary drugs such as dexmedetomidine altogether with the local anesthetic allows a reduction in the dosage, as well as in the requirements for analgesics and sedative drugs along the procedure and through the first hours of the postoperative period.

Dexmedetomidine properly carries its mechanism of action in the pre and post synaptic alpha-2 receptors along the dorsal horn of the spinal cord, decreasing the release of neurotransmitters and thus the pulsatile transmission of impulses. On the other hand, when administered as an IV infusion, this alpha agonist has shown the ability to reach light sedation levels, easily reversed by verbal or tactile stimulus. When acting at the locus coeruleus presynaptic spots, the effect of trans and postoperative analgesia can also be consistently observed. Because of these characteristics, the benefits of intravenous dexmedetomidine have been recently tested over the length and quality of spinal anesthesia with local anesthetics, by being administered as bolus and then as maintenance infusion at variable doses per kilogram.

This therapeutic alternative has been applied during several types of infraumbilical surgeries, such as varicocelectomy, hernioplasty, orchiectomy, and lower limb interventions, without the risk of producing nausea, vomiting, headache, or shivering. The use of this adjuvant provides longer lasting nervous blockade, as well higher time for postoperative analgesia, which helps to reduce the consumption of sedative drugs and opioids since the beginning of the intervention until up to the following first 24 hours. Finally, the undesired effects that have been reported in some populations when receiving this drug (hypotension and bradycardia), appear unfrequently and can be easily reversed with the use of common prescription hemodynamic drugs (atropine, ephedrine).

However, it is common to observe differing therapeutic responses following drug administration during daily clinical practice, which can be often attributed to interindividual differences in drug pharmacokinetics, linked to race, ethnicity, and social habits, that can develop enzymatic variations or genetic polymorphisms. Currently, there are many bibliographic references that support the theories that punctually describe these changes in pharmacological responses between ethnic groups, which is why there is a constant need for testing the efficacy and safety of certain drugs, to improve patient safety and clinical outcomes in all the medical fields.

In this case, the objective of our trial is to evaluate the clinical response to the therapeutic scheme based on intravenous dexmedetomidine added to spinal anesthesia. We expect to determine if this drug could and should be considered regularly as an adjuvant to prolong the duration and improve the anesthetic and analgesic conditions of neuraxial blockade with intrathecal bupivacaine in orthopedic lower limb surgery.

Being tested
Dexmedetomidine injection, Sodium Chloride 0.9% infusion

What participants receive

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

  • Dexmedetomidine injectionDrug

    Also called Precedex infusion

    IV initial bolus and trans operative dexmedetomidine infusion.

  • Sodium Chloride 0.9% infusionDrug

    Also called Placebo

    IV initial bolus and trans operative infusion of 0.9% saline solution.

Study groups in NCT05335655
Study groupRoleWhat they receive
Group AActive comparatorIV bolus of dexmedetomidine, blindly administered and tittered to 0.5mcg per kilogram (real weight), diluted in 10 ml of 0.9% saline solution during 15 minutes before the spinal block. Once the anesthetic effect is confirmed, the maintenance IV infusion, based on dexmedetomidine 100 mcg diluted in 100 ml of 0.9% saline solution tittered at 0.5 mcg per kilogram per hour (real weight), begins.
Receives: Drug: Dexmedetomidine injection
Group BPlacebo comparatorIV 10 ml initial bolus of 0.9% saline solution during the 15 minutes before the spinal block. Once de anesthetic effect is confirmed, the maintenance infusion of IV 0.9% saline solution (100 ml in equivalent dosage per hour) begins.
Receives: Drug: Sodium Chloride 0.9% infusion

What is being measured

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

  1. Total time of spinal anesthesia with hyperbaric bupivacaine

    Time (minutes) from anesthetic onset, until first sign (sensitive/motor) of blockade regression.

    Measured: Up to 300 minutes

  2. Presence of post-operative pain

    Patient refers pain (Yes or No)

    Measured: Up to 120 minutes

Secondary outcomes (1)
  1. Adverse effects Adverse Effects

    Hypotension and/or Bradycardia during drug infusion

    Measured: Through anesthetic period while administering IV drug

Timeline

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

  1. First posted19 Apr 2022
  2. Study start31 Jan 2022
  3. Primary completion10 Jun 2022 (estimated)
  4. Study completion15 Jun 2022 (estimated)

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05335655
Sponsor's protocol ID
24-CEI-001-20160427
Status last verified
Jun 2022
First submitted
23 Mar 2022
Last updated
13 Jun 2022
Results posted
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 3 study testing Dexmedetomidine injection and Sodium Chloride 0.9% infusion in people with Anesthesia and Dexmedetomidine, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.

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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 13 Jun 2022. 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 Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liliana Serrano Ibarrola, MD (+52 3313270064, ibarrola_92@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total time of spinal anesthesia with hyperbaric bupivacaine (time frame: Up to 300 minutes). The study lists 2 primary outcomes in all. 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 Jun 2022.

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