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.
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.
Mexico1 site, 1 recruiting
- 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
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.
- Conditions
- Anesthesia, Dexmedetomidine
- 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 group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | IV 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 B | Placebo comparator | IV 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.
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
Presence of post-operative pain
Patient refers pain (Yes or No)
Measured: Up to 120 minutes
Secondary outcomes (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.
- First posted19 Apr 2022
- Study start31 Jan 2022
- Primary completion10 Jun 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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 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)
Sponsor and investigators
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liliana Serrano Ibarrola, Hospital Central "Dr. Ignacio Morones Prieto"
- Investigators
- Juan Francisco Hernández Sierra, M in C, Study director, Universidad Autonoma de San Luis Potosí
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05335655
- Acronym / sponsor ID
- 24-CEI-001-20160427
- Conditions
- Anesthesia, Dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"University, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 19 Apr 2022 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexmedetomidine injectionIV 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. |
| Group B | Placebo comparator | Drug: Sodium Chloride 0.9% infusionIV 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 injectionAlso: Precedex infusionIV initial bolus and trans operative dexmedetomidine infusion. | Drug | Group A |
| Sodium Chloride 0.9% infusionAlso: PlaceboIV initial bolus and trans operative infusion of 0.9% saline solution. | Drug | Group B |
Primary outcome
Total time of spinal anesthesia with hyperbaric bupivacaine
Time frame: Up to 300 minutes
Time (minutes) from anesthetic onset, until first sign (sensitive/motor) of blockade regression.
Presence of post-operative pain
Time frame: Up to 120 minutes
Patient refers pain (Yes or No)
1 secondary outcome
Adverse effects Adverse Effects
Time frame: Through anesthetic period while administering IV drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- 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.
Juan Francisco Hernández Sierra, M in C study director
Universidad Autonoma de San Luis Potosí
1 site in 1 country: see every site and its status.
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.