Spinal Anesthesia DurationNCT03143010
Comparison of Different Doses of Dexmedetomidine Effect in the Duration of Spinal Anesthesia
A study testing intrathecal Dexmedetomidine, Dexmedetomidine 1.5 micrograms and Dexmedetomidine 3 micrograms in people with Spinal Anesthesia Duration, run by Cairo University at 1 site in Egypt.
Trial summary
Small doses of dexmedetomidine1.5,3, 5µg used in combination with bupivacaine, in humans for spinal anesthesia has been shown to produce a more rapid onset of motor block, and a longer duration of motor and sensory block with preserved hemodynamic stability and lack of sedation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Anesthesia Duration
- What is being tested?
- intrathecal Dexmedetomidine, Dexmedetomidine 1.5 micrograms and Dexmedetomidine 3 micrograms
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 7 May 2017to 30 Jul 2017
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients' physical status by the American Association of Anesthesiology (ASA): ASA I, II, III, undergoing Lower abdominal surgeries of maximum duration 2hrs
Who cannot join
- patients who refuse regional anesthesia or patient with bleeding tendency, taking α2- adrenergic agonist, labile hypertension, uncontrolled cardiac disease, heart block/dysrhythmia, difficulty in communication e.g. mental retardation or deafness, body weight more than 120kg or height less than 150cm, allergic to any of the drugs used in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Giza Governorate, 1234
HASSAN M ALI, LECTURER, +201001733687, hassan364@hotmail.com
About this study
Small doses of dexmedetomidine1.5,3, 5µg used in combination with bupivacaine, in humans for spinal anesthesia has been shown to produce a more rapid onset of motor block, and a longer duration of motor and sensory block with preserved hemodynamic stability and lack of sedation.
Read the detailed description
Spinal anesthesia has many advantages such as reducing the metabolic stress response to surgery, reduction in blood loss, decrease in the incidence of venous thromboembolism, reduction in pulmonary compromise (particularly in patients with advanced pulmonary disease),return of bowel function rapidly, allow hospital discharge early and the ability to monitor the patient's mental status, but the limited duration of action is one of its disadvantages. Intrathecal α2-agonists prolong the duration of action of local anesthetics and reduce the total required dose.(1, 2) Dexmedetomidine is a centrally acting highly specific α2 -agonist and its α2/α1 selectivity are 8 times higher than that of clonidine.(3) It is commonly used as a sedative, preemptive analgesic,(4) to decrease the incidence of postoperative nausea, vomiting (PONV)(5) and to maintain stable hemodynamics(6). It also has been used as an additive to local anesthetics in peripheral nerve blocks, brachial plexus block7, subarachnoid anesthesia and caudal anesthesia (8).
Local anesthetics have been widely used in medical practice to produce anesthesia, analgesia and for pain management. Nowadays, minor surgical operations have been done under local anesthesia outside the operating theaters, in this area monitoring and resuscitation facilities of the case are suboptimal compared to operating rooms. The complications of local anesthesia are different from localized reactions such as urticaria, edema, and dermatitis to systemic absorption leading to severe cardiovascular collapse and neurological toxicity. The incidence of local anesthetics to produce systemic toxicity decreased in the past 30 years, from 0.2 to 0.01 %.( 9) Recently, patient safety changes a clinician's perspective on understanding the pharmacology of drug interactions and complications of local anesthetics. The safety of local anesthetic usage has improved owing to the introduction of newer agents (eg; Ropivacaine and Levobupivacaine). (10) Levobupivacaine is a long-acting local anesthetic similar to that of Bupivacaine in a pharmacological structure. Bupivacaine, a widely used local anesthetic in regional anesthesia presents in a commercial preparation as a racemic mixture (50:50) of its two enantiomers, Levobupivacaine, S (-) isomer and destroy- bupivacaine, R (+) isomer.
Levobupivacaine has been shown to have a safer pharmacological profile (11) with less cardiac and neurotoxic adverse effects. (12) Small doses of dexmedetomidine 5µg used in combination with Levobupivacaine, in humans for spinal anesthesia has been shown to produce a more rapid onset of motor block, and a longer duration of motor and sensory block with preserved hemodynamic stability and lack of sedation2.
- Conditions
- Spinal Anesthesia Duration
- Being tested
- intrathecal Dexmedetomidine, Dexmedetomidine 1.5 micrograms, Dexmedetomidine 3 micrograms, Dexmedetomidine 5 micrograms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal DexmedetomidineDrug
Also called saline intrathecally
injection of different doses of Dexmedetomidine intrathecally received 3mL (15mg) of 0.5% levobupivacaine +0.5mL normal saline.
Dexmedetomidine 1.5 microgramsDrug
Also called Dexmedetomidine 1.5 micrograms intrathecally
injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 1.5 micrograms of Dexmedetomidine.
Dexmedetomidine 3 microgramsDrug
Also called Dexmedetomidine 3 micrograms intrathecally
injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 3 micrograms of Dexmedetomidine.
Dexmedetomidine 5 microgramsDrug
Also called Dexmedetomidine 5 micrograms intrathecally
injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 5 micrograms of Dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | intrathecal Dexmedetomidine received 3mL (15mg) of 0.5% levobupivacaine +0.5mL normal saline . Receives: Drug: intrathecal Dexmedetomidine |
| 1.5 DEX | Experimental | Dexmedetomidine 1.5 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (1.5μg) dexmedetomidine Receives: Drug: Dexmedetomidine 1.5 micrograms |
| 3 DEX | Experimental | Dexmedetomidine 3 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (3μg) dexmedetomidine Receives: Drug: Dexmedetomidine 3 micrograms |
| 5 DEX | Experimental | Dexmedetomidine 5 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (5μg) dexmedetomidine Receives: Drug: Dexmedetomidine 5 micrograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of sensory block
time from onset of spinal to full recovery
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start7 May 2017
- Primary completion30 Jul 2017 (estimated)
- Study completion30 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthesia DurationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143010
- Sponsor's protocol ID
- Dexmedetomidine12
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Doses of Dexmedetomidine Effect in the Duration of Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03143010
- Acronym / sponsor ID
- Dexmedetomidine12
- Conditions
- Spinal Anesthesia Duration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 May 2017 (actual)
- Primary completion
- 30 Jul 2017 (estimated)
- Study completion
- 30 Jul 2017 (estimated)
- First posted
- 8 May 2017 (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.
Small doses of dexmedetomidine1.5,3, 5µg used in combination with bupivacaine, in humans for spinal anesthesia has been shown to produce a more rapid onset of motor block, and a longer duration of motor and sensory block with preserved hemodynamic stability and lack of sedation.
Detailed description
Spinal anesthesia has many advantages such as reducing the metabolic stress response to surgery, reduction in blood loss, decrease in the incidence of venous thromboembolism, reduction in pulmonary compromise (particularly in patients with advanced pulmonary disease),return of bowel function rapidly, allow hospital discharge early and the ability to monitor the patient's mental status, but the limited duration of action is one of its disadvantages. Intrathecal α2-agonists prolong the duration of action of local anesthetics and reduce the total required dose.(1, 2) Dexmedetomidine is a centrally acting highly specific α2 -agonist and its α2/α1 selectivity are 8 times higher than that of clonidine.(3) It is commonly used as a sedative, preemptive analgesic,(4) to decrease the incidence of postoperative nausea, vomiting (PONV)(5) and to maintain stable hemodynamics(6). It also has been used as an additive to local anesthetics in peripheral nerve blocks, brachial plexus block7, subarachnoid anesthesia and caudal anesthesia (8).
Local anesthetics have been widely used in medical practice to produce anesthesia, analgesia and for pain management. Nowadays, minor surgical operations have been done under local anesthesia outside the operating theaters, in this area monitoring and resuscitation facilities of the case are suboptimal compared to operating rooms. The complications of local anesthesia are different from localized reactions such as urticaria, edema, and dermatitis to systemic absorption leading to severe cardiovascular collapse and neurological toxicity. The incidence of local anesthetics to produce systemic toxicity decreased in the past 30 years, from 0.2 to 0.01 %.( 9) Recently, patient safety changes a clinician's perspective on understanding the pharmacology of drug interactions and complications of local anesthetics. The safety of local anesthetic usage has improved owing to the introduction of newer agents (eg; Ropivacaine and Levobupivacaine). (10) Levobupivacaine is a long-acting local anesthetic similar to that of Bupivacaine in a pharmacological structure. Bupivacaine, a widely used local anesthetic in regional anesthesia presents in a commercial preparation as a racemic mixture (50:50) of its two enantiomers, Levobupivacaine, S (-) isomer and destroy- bupivacaine, R (+) isomer.
Levobupivacaine has been shown to have a safer pharmacological profile (11) with less cardiac and neurotoxic adverse effects. (12) Small doses of dexmedetomidine 5µg used in combination with Levobupivacaine, in humans for spinal anesthesia has been shown to produce a more rapid onset of motor block, and a longer duration of motor and sensory block with preserved hemodynamic stability and lack of sedation2.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: intrathecal Dexmedetomidineintrathecal Dexmedetomidine received 3mL (15mg) of 0.5% levobupivacaine +0.5mL normal saline . |
| 1.5 DEX | Experimental | Drug: Dexmedetomidine 1.5 microgramsDexmedetomidine 1.5 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (1.5μg) dexmedetomidine |
| 3 DEX | Experimental | Drug: Dexmedetomidine 3 microgramsDexmedetomidine 3 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (3μg) dexmedetomidine |
| 5 DEX | Experimental | Drug: Dexmedetomidine 5 microgramsDexmedetomidine 5 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (5μg) dexmedetomidine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients' physical status by the American Association of Anesthesiology (ASA): ASA I, II, III, undergoing Lower abdominal surgeries of maximum duration 2hrs
Key exclusion criteria (1 listed)
- patients who refuse regional anesthesia or patient with bleeding tendency, taking α2- adrenergic agonist, labile hypertension, uncontrolled cardiac disease, heart block/dysrhythmia, difficulty in communication e.g. mental retardation or deafness, body weight more than 120kg or height less than 150cm, allergic to any of the drugs used in the study
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 |
|---|---|---|
| intrathecal DexmedetomidineAlso: saline intrathecallyinjection of different doses of Dexmedetomidine intrathecally received 3mL (15mg) of 0.5% levobupivacaine +0.5mL normal saline. | Drug | control group |
| Dexmedetomidine 1.5 microgramsAlso: Dexmedetomidine 1.5 micrograms intrathecallyinjection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 1.5 micrograms of Dexmedetomidine. | Drug | 1.5 DEX |
| Dexmedetomidine 3 microgramsAlso: Dexmedetomidine 3 micrograms intrathecallyinjection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 3 micrograms of Dexmedetomidine. | Drug | 3 DEX |
| Dexmedetomidine 5 microgramsAlso: Dexmedetomidine 5 micrograms intrathecallyinjection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 5 micrograms of Dexmedetomidine. | Drug | 5 DEX |
Primary outcome
duration of sensory block
Time frame: 6 hours
time from onset of spinal to full recovery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrathecal Dexmedetomidine, Dexmedetomidine 1.5 micrograms and Dexmedetomidine 3 micrograms in people with Spinal Anesthesia Duration, run by Cairo University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 9 May 2017. 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 Egypt. 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.
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 Hassan Ali, lecturer (1001733687, hassan364@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of sensory block (time frame: 6 hours). 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 9 May 2017.