Cesarean SectionPhase 2/3NCT03775655
Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section
A Phase 2/3 study testing Dexmedetomidine in people with Cesarean Section and Spinal Anesthesia, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Spinal Anesthesia, Dexmedetomidine
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 10 Jan 2019
- Phase
- Phase 2/3
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-term pregnant women
- Singleton gestation
- American Society of Anaesthesiologists (ASA) physical status classes II and I
Who cannot join
- Preterm pregnancy (<37 wks. gestation)
- Multiple gestation
- Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications
- Asthma and allergy to non-steroidal anti-inflammatory drugs
- Conditions that prevent spinal anaesthesia
- Failed spinal block and conversion to general anaesthesia
Show all 10Show fewer
- A history of established chronic pain
- Drug addiction
- A psychiatric disorder
- Inability to communicate effectively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section: Randomized Controlled Trial
The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic.
- Conditions
- Cesarean Section, Spinal Anesthesia, Dexmedetomidine
- Being tested
- Dexmedetomidine
- Keywords
- Cesarean Section, Intrathecal Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
10μg dexmedetomidine will be added to the injectate to be injected intrathecally
| Study group | Role | What they receive |
|---|---|---|
| LD-DEX | Active comparator | This group will receive 7mg hyperbaric bupivacaine (about 1.4 ml of hyperbaric bupivacaine 0.5%) and 10μg dexmedetomidine (10 unit by U-100 insulin syringe using a preservative free dexmedetomidine 100μg/ml). Receives: Drug: Dexmedetomidine |
| Control group | No intervention | This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Density of motor and sensory blockade
Measured: Intraoperative
Haemodynamic stability and total doses of IV fluids and vasopressors
Measured: Intraoperative
Time to first postoperative rescue analgesic request
Measured: 24 hour
Secondary outcomes (12)
The intraoperative patient and surgeon satisfaction (successful delivery)
Measured: Intraoperative
The peak sensory level of block
Measured: Intraoperative
Time from intrathecal injection to peak sensory block level
Measured: Intraoperative
The time to two sensory block segment regression
Measured: Intraoperative and 24 hour
Degree and duration of motor block
Measured: Intraoperative and 24 hour
Intraoperative analgesic supplementation during operation
Measured: Intraoperative
Postoperative pain scores for 24 hours
Measured: 24 hour
Frequency and total dose of postoperative analgesics
Measured: 24 hour
Intraoperative and postoperative sedation scores
Measured: Intraoperative and 24 hour
Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation.
Measured: Intraoperative and 24 hour
Hospital in stay
Measured: 24 hour
Time to S1 level sensory regression
Measured: Intraoperative and 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start1 Sep 2018
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Menoufia 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ashraf Nasr, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775655
- Sponsor's protocol ID
- 9076411
- Status last verified
- Jan 2019
- First submitted
- 12 Dec 2018
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03775655
- Acronym / sponsor ID
- 9076411
- Conditions
- Cesarean Section, Spinal Anesthesia, Dexmedetomidine
- Keywords
- Cesarean Section, Intrathecal Dexmedetomidine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 14 Dec 2018 (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.
The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LD-DEX | Active comparator | Drug: DexmedetomidineThis group will receive 7mg hyperbaric bupivacaine (about 1.4 ml of hyperbaric bupivacaine 0.5%) and 10μg dexmedetomidine (10 unit by U-100 insulin syringe using a preservative free dexmedetomidine 100μg/ml). |
| Control group | No intervention | –This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Full-term pregnant women
- Singleton gestation
- American Society of Anaesthesiologists (ASA) physical status classes II and I
Key exclusion criteria (10 listed)
- Preterm pregnancy (<37 wks. gestation)
- Multiple gestation
- Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications
- Asthma and allergy to non-steroidal anti-inflammatory drugs
- Conditions that prevent spinal anaesthesia
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex10μg dexmedetomidine will be added to the injectate to be injected intrathecally | Drug | LD-DEX |
Primary outcome
Density of motor and sensory blockade
Time frame: Intraoperative
Haemodynamic stability and total doses of IV fluids and vasopressors
Time frame: Intraoperative
Time to first postoperative rescue analgesic request
Time frame: 24 hour
12 secondary outcomes
The intraoperative patient and surgeon satisfaction (successful delivery)
Time frame: Intraoperative
The peak sensory level of block
Time frame: Intraoperative
Time from intrathecal injection to peak sensory block level
Time frame: Intraoperative
The time to two sensory block segment regression
Time frame: Intraoperative and 24 hour
Degree and duration of motor block
Time frame: Intraoperative and 24 hour
Intraoperative analgesic supplementation during operation
Time frame: Intraoperative
Postoperative pain scores for 24 hours
Time frame: 24 hour
Frequency and total dose of postoperative analgesics
Time frame: 24 hour
Intraoperative and postoperative sedation scores
Time frame: Intraoperative and 24 hour
Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation.
Time frame: Intraoperative and 24 hour
Hospital in stay
Time frame: 24 hour
Time to S1 level sensory regression
Time frame: Intraoperative and 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine in people with Cesarean Section and Spinal Anesthesia, run by Menoufia 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 8 Oct 2026. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Density of motor and sensory blockade (time frame: Intraoperative). The study lists 3 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 8 Oct 2026.