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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Talaat Ahmed
Asyut, 71111
ahmed talaat, 01062716629
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.
- Conditions
- Cesarean Section
- 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 group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Patients will receive intrathecal hyperbaric bupivacaine 12.5 mg in 2.5 ml Receives: Drug: Bupivacaine |
| Group D | Active comparator | Patients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with dexmdetomidine 5 µg in 0.5 ml normal saline . Receives: Drug: Dexmedetomidine |
| Group M | Active comparator | Patients 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.
Visual Analogue Scale
analgesia will be given if VAS is 4 or more
Measured: 6 hours
Secondary outcomes (2)
heart rate
effect of study drugs on the maternal heart rate
Measured: 6 hours
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.
- First posted1 Mar 2017
- Study startJun 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed talaat ahmed aly, Assiut University
- Investigators
- Zain E. Hassan, MD, Study director, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Dexmedetomidine Versus Magnesium Sulphate to Intrathecal Bupivacaine on Spinal Block and Neonatal Outcome in Uncomplicated Caesarean Delivery
- ClinicalTrials.gov ID
- NCT03067896
- Acronym / sponsor ID
- assuit university
- Conditions
- Cesarean Section
- Keywords
- spinal block, stress response, dexmedetomidine, intrathecally
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 1 Mar 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Drug: BupivacainePatients will receive intrathecal hyperbaric bupivacaine 12.5 mg in 2.5 ml |
| Group D | Active comparator | Drug: DexmedetomidinePatients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with dexmdetomidine 5 µg in 0.5 ml normal saline . |
| Group M | Active comparator | Drug: Magnesium SulfatePatients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with magnesium sulfate 50 mg in 0.5 ml normal saline . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 45 years
- Undergo elective cesarean section under spinal anesthesia.
- ASA physical status Ӏ-ӀӀ .
- Singleton pregnancy .
- At least 36 weaks gestation .
Key exclusion criteria (6 listed)
- 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 .
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 |
|---|---|---|
| BupivacainePatients will receive intrathecal hyperbaric bupivacaine 12.5 mg in 2.5 ml | Drug | Group C |
| DexmedetomidinePatients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with dexmdetomidine 5 µg in 0.5 ml normal saline | Drug | Group D |
| Magnesium SulfatePatients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml magnesium sulfate 50 mg in 0.5 ml normal saline | Drug | Group M |
Primary outcome
Visual Analogue Scale
Time frame: 6 hours
analgesia will be given if VAS is 4 or more
2 secondary outcomes
heart rate
Time frame: 6 hours
blood pressure
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Derived from this study: PubMed 31461801Mostafa 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.
- 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.
Zain E. Hassan, MD study director
Assiut University
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 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.