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Cesarean SectionPhase 3NCT03067896

Dexmedetomidine Versus Magnesium Sulphate for Caesarean Delivery

A Phase 3 study testing Bupivacaine, Dexmedetomidine and Magnesium Sulfate in people with Cesarean Section, run by Assiut 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Regional anesthesia has become more popular in cesarean deliveries because most of the parturients prefer being awake during the birth process. In addition, regional anesthesia may be a safer method than general. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cesarean Section
What is being tested?
Bupivacaine, Dexmedetomidine and Magnesium Sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteEgypt
Study dates
Jun 2015to Mar 2017
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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18 to 45 years
  • Undergo elective cesarean section under spinal anesthesia.
  • ASA physical status Ӏ-ӀӀ .
  • Singleton pregnancy .
  • At least 36 weaks gestation .

Who cannot join

  • Women with a history of cardiac , liver , or kidney diseases .
  • Women with allergy to amide local anesthetics or medications included in the study .
  • Women with any neurological problem .
  • Any contraindication of regional anesthesia .
  • Women with evidence of intrauterine growth restriction or fetal compromise .
  • Failed or insatisfactory spinal block .

Trial locations and contacts

1 site in 1 country.

MOHAMED F. MOSTAFA, MD contact

01001123062 ext. 002

mo7_fathy@yahoo.com

Egypt1 site, 1 recruiting
  • Ahmed Talaat Ahmed

    Asyut, 71111

    ahmed talaat, 01062716629

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Adding Dexmedetomidine Versus Magnesium Sulphate to Intrathecal Bupivacaine on Spinal Block and Neonatal Outcome in Uncomplicated Caesarean Delivery

Regional anesthesia has become more popular in cesarean deliveries because most of the parturients prefer being awake during the birth process. In addition, regional anesthesia may be a safer method than general. In spinal anesthesia local anesthetics alone may not be enough for an effective postoperative analgesia and hemodynamic stability of the patient wich is crucial during cesarean section. So far many adjuvants have been used to augment the analgesia produced by intrathecal local anesthetics and to reduce their adverse effects .

Various intrathecal adjuvants to local anaesthetics have found to improve the quality and extend duration of spinal block. Prolongation of duration of spinal block is desirable both for long procedures and for postoperative pain relief. Efficacy and safty of intrathecal magnesium as analgesic adjuvant has been tested by several clinical trails in recent years.Antinociceptive effect of magnesium appears to be relevant for the management of chronic and post operative pain. These effects are primarily based on regulation of calcium influx in to the cell. Magnesium blocks calcium influx and non competitively antagonizes NMDA channels. NMDA receptor signelling plays an impartent in determining the duration of acute pain3).) addition of magnesium to spinal anaesthesia improved postoperative analgesia in orthopedic setting. addition of intrathecal magnesium sulfate to 10 mg bupivacaine plus 25µg fentanyl prolonged spinal anaesthesia in patients undergoing lower extremity surgery.

Read more

Dexmedetomidine is a highly selective 2-adrenergic agonist which has been used as pre-medication and as an adjuvant to general anesthesia.Dexmedetomidine have several beneficial actions during perioperative period. They decrease sympathetic tone with attenuation of the neuroendocrine and haemodynamic response to anaesthesia and surgery, reduce anaesthetic and opiod requirement, cause sedation and analgesia. Dexmedetomidine was first introduced into clinical practice as a short term intravenous sedative in intensive care. Like any other adjuvant dexmedetomidine is not free from adverse effects. Use of dexmedetomidine is often associated with a decrease in heart rate and blood pressure.Dexmedetomidine was used to enhance the analgesic property of local anaesthetics like lidocaine bupivacaine and ropivacaine. In vivo and in vitro studies indicated that these local anaesthetics had significant neurotoxicity. Dexmedetomidine showed protective or growth promoting properties in tissues, including nerve cells from cortex. Intrathecal dexmedetomidine has a neuroprotective effect similar to methylprednisolone.

The mechanism by which intrathecal alpha 2-adrenergic agonists prolong the motor and sensory block of local anesthetics is not clear. It may be an additive or synergistic effect secondary to the different mechanisms of action of local anesthetic and alpha 2 adrenergic agonist. The local anesthetics act by blocking sodium channels, whereas the alpha 2 adrenergic agonist acts by binding to pre synapyic C fibre and post synaptic dorsal horn neurons. Intrathecal alpha 2 adrenergic agonist produce analgesia by depressing the realease of C fibre transmission by hyperpolarization of post synaptic dorsal horn neurons. Li et al observed that Glutamate is involved in excitatory neurotransmission nociception and plays an essential role in relaying noxious stimuli in the spinal cord. Intrathecal injection of alpha 2 adrenergic agonists produces potent antinociceptive effects by altering spinal neurotransmitter release and effectively treats acute pain.

Being tested
Bupivacaine, Dexmedetomidine, Magnesium Sulfate
Keywords
spinal block, stress response, dexmedetomidine, intrathecally
Medical subject headings
Fractures, Stress

What participants receive

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

  • BupivacaineDrug

    Patients will receive intrathecal hyperbaric bupivacaine 12.5 mg in 2.5 ml

  • DexmedetomidineDrug

    Patients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with dexmdetomidine 5 µg in 0.5 ml normal saline

  • Magnesium SulfateDrug

    Patients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml magnesium sulfate 50 mg in 0.5 ml normal saline

Study groups in NCT03067896
Study groupRoleWhat they receive
Group CActive comparatorPatients will receive intrathecal hyperbaric bupivacaine 12.5 mg in 2.5 ml
Receives: Drug: Bupivacaine
Group DActive comparatorPatients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with dexmdetomidine 5 µg in 0.5 ml normal saline .
Receives: Drug: Dexmedetomidine
Group MActive comparatorPatients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with magnesium sulfate 50 mg in 0.5 ml normal saline .
Receives: Drug: Magnesium Sulfate

What is being measured

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

  1. Visual Analogue Scale

    analgesia will be given if VAS is 4 or more

    Measured: 6 hours

Secondary outcomes (2)
  1. heart rate

    effect of study drugs on the maternal heart rate

    Measured: 6 hours

  2. blood pressure

    effect of study drugs on the maternal mean blood pressure

    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 posted1 Mar 2017
  2. Study startJun 2015
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03067896
Sponsor's protocol ID
assuit university
Status last verified
Feb 2017
First submitted
12 Jul 2015
Last updated
1 Mar 2017
Results posted
No
Individual data sharing
Undecided

Publications

  • Mostafa MF, Herdan R, Fathy GM, Hassan ZEAZ, Galal H, Talaat A, Ibrahim AK. Intrathecal dexmedetomidine versus magnesium sulphate for postoperative analgesia and stress response after caesarean delivery; randomized controlled double-blind study. Eur J Pain. 2020 Jan;24(1):182-191. doi: 10.1002/ejp.1476. Epub 2019 Sep 12.

    PubMed 31461801

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bupivacaine, Dexmedetomidine and Magnesium Sulfate in people with Cesarean Section, run by Assiut 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 5 inclusion and 6 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 1 Mar 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. 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 MOHAMED F. MOSTAFA, MD (01001123062 ext. 002, mo7_fathy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (time frame: 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067896, which also lists 1 linked publication.

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 1 Mar 2017.

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