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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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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.

Hassan Ali, lecturer contact

1001733687

hassan364@hotmail.com

Bassant Hassan, lecturer contact

+201001733687

hassan364@hotmail.com

Egypt1 site, 1 recruiting
  • Cairo University

    Cairo, Giza Governorate, 1234

    HASSAN M ALI, LECTURER, +201001733687, hassan364@hotmail.com

    Recruiting

Other trials in Egypt

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.

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 groups in NCT03143010
Study groupRoleWhat they receive
control groupPlacebo comparatorintrathecal Dexmedetomidine received 3mL (15mg) of 0.5% levobupivacaine +0.5mL normal saline .
Receives: Drug: intrathecal Dexmedetomidine
1.5 DEXExperimentalDexmedetomidine 1.5 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (1.5μg) dexmedetomidine
Receives: Drug: Dexmedetomidine 1.5 micrograms
3 DEXExperimentalDexmedetomidine 3 micrograms received 3mL (15mg) of 0.5% levobupivacaine +0.5ml (3μg) dexmedetomidine
Receives: Drug: Dexmedetomidine 3 micrograms
5 DEXExperimentalDexmedetomidine 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.

  1. 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.

  1. First posted8 May 2017
  2. Study start7 May 2017
  3. Primary completion30 Jul 2017 (estimated)
  4. Study completion30 Jul 2017 (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 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)
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

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.

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