AnesthesiaPhase 2NCT07465185
Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery
A Phase 2 study testing Bupivacaine and Bupivacaine and Dexmedetomidine in people with Anesthesia, run by Benha University at 1 site in Egypt.
Trial summary
Cesarean section (CS) is one of the most frequently performed surgical procedures globally, with an increasing demand for safe and effective anesthesia techniques. Regional anesthesia, particularly intrathecal anesthesia, has become the method of choice for elective cesarean deliveries.The most commonly used local… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Bupivacaine and Bupivacaine and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2026to 1 Sep 2026
- Phase
- Phase 2
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (1) Full-term pregnant women undergoing elective cesarean section under spinal anesthesia. (2) Age: 20 ~ 35 years. (3) ASA physical status II ~ III
Who cannot join
- Multiple pregnancies.
- Cardiovascular disease(e.g., pre-eclampsia and hypertension).
- Serious hepatic dysfunction (Child-Pugh class C).
- serious renal dysfunction (undergoing dialysis before surgery).
- History of alcohol or opioid addiction.
- Contraindication to spinal anesthesia.
- Refusing to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery ;Arandomized Non - Inferiority Study
Cesarean section (CS) is one of the most frequently performed surgical procedures globally, with an increasing demand for safe and effective anesthesia techniques. Regional anesthesia, particularly intrathecal anesthesia, has become the method of choice for elective cesarean deliveries.The most commonly used local anesthetic for intrathecal anesthesia is bupivacaine.Recent studies have focused on adjunctive agents to enhance the efficacy of local anesthetics.
- Conditions
- Anesthesia
- Being tested
- Bupivacaine, Bupivacaine and Dexmedetomidine
- Keywords
- bupivacaine, dexmetomedine, spinal anesthesia, cessarian delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
patient will receive intra-thecal hyperbaric bupivacaine 11 mg(2.2 ml) of 0.5% bupivacaine, with 0.5 ml of normal saline in total volume 2.5 ml.
Bupivacaine and DexmedetomidineDrug
patient will receive 9 mg (1.8 ml) of 0. 5% bupivacaine, with 5 μg of DEX in 0.5ml of normal saline in total volume 2.5 ml.
| Study group | Role | What they receive |
|---|---|---|
| Group (B) | Active comparator | will receive intra-thecal hyperbaric bupivacaine 11 mg(2.2 ml) of 0.5% bupivacaine, with 0.5 ml of normal saline in total volume 2.5 ml. Receives: Drug: Bupivacaine |
| Group (BD) | Active comparator | will receive 9 mg (1.8 ml) of 0. 5% bupivacaine, with 5 μg of DEX in 0.5ml of normal saline in total volume 2.5 ml. Receives: Drug: Bupivacaine and Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of sensory block
time taken from intrathecal injection to sensory regression to S1 dermatome.
Measured: after anesthesia up to 12 hours postoperatively
Secondary outcomes (3)
the onset time of sensory block
time taken from intrathecal injection to the maternal feeling of lower extremities temperature increment or numbness
Measured: during 30 minutes after intrathecal injection
the onset time of motor block
time taken from intrathecal injection to MBS > 1
Measured: during 30 minutes after intrathecal injection
The recovery quality of parturients
ObsQoR-11, score from 0 to 10 in each term, where 0 = strongly agree and 10 = strongly disagree, the higher of the score, the higher of recovery quality
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start15 Mar 2026
- Primary completion15 Aug 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Benha 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmed Abdel Fatah, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465185
- Sponsor's protocol ID
- RC 17-2-2026
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Sep 2026
- Results posted
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery ;Arandomized Non - Inferiority Study
- ClinicalTrials.gov ID
- NCT07465185
- Acronym / sponsor ID
- RC 17-2-2026
- Conditions
- Anesthesia
- Keywords
- bupivacaine, dexmetomedine, spinal anesthesia, cessarian delivery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 11 Mar 2026 (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.
Cesarean section (CS) is one of the most frequently performed surgical procedures globally, with an increasing demand for safe and effective anesthesia techniques. Regional anesthesia, particularly intrathecal anesthesia, has become the method of choice for elective cesarean deliveries.The most commonly used local anesthetic for intrathecal anesthesia is bupivacaine.Recent studies have focused on adjunctive agents to enhance the efficacy of local anesthetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (B) | Active comparator | Drug: Bupivacainewill receive intra-thecal hyperbaric bupivacaine 11 mg(2.2 ml) of 0.5% bupivacaine, with 0.5 ml of normal saline in total volume 2.5 ml. |
| Group (BD) | Active comparator | Drug: Bupivacaine and Dexmedetomidinewill receive 9 mg (1.8 ml) of 0. 5% bupivacaine, with 5 μg of DEX in 0.5ml of normal saline in total volume 2.5 ml. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) Full-term pregnant women undergoing elective cesarean section under spinal anesthesia. (2) Age: 20 ~ 35 years. (3) ASA physical status II ~ III
Key exclusion criteria (7 listed)
- Multiple pregnancies.
- Cardiovascular disease(e.g., pre-eclampsia and hypertension).
- Serious hepatic dysfunction (Child-Pugh class C).
- serious renal dysfunction (undergoing dialysis before surgery).
- History of alcohol or opioid addiction.
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 |
|---|---|---|
| Bupivacainepatient will receive intra-thecal hyperbaric bupivacaine 11 mg(2.2 ml) of 0.5% bupivacaine, with 0.5 ml of normal saline in total volume 2.5 ml. | Drug | Group (B) |
| Bupivacaine and Dexmedetomidinepatient will receive 9 mg (1.8 ml) of 0. 5% bupivacaine, with 5 μg of DEX in 0.5ml of normal saline in total volume 2.5 ml. | Drug | Group (BD) |
Primary outcome
the duration of sensory block
Time frame: after anesthesia up to 12 hours postoperatively
time taken from intrathecal injection to sensory regression to S1 dermatome.
3 secondary outcomes
the onset time of sensory block
Time frame: during 30 minutes after intrathecal injection
the onset time of motor block
Time frame: during 30 minutes after intrathecal injection
The recovery quality of parturients
Time frame: 24 hours post-operatively
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 4 Sep 2026.
- 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.
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 study testing Bupivacaine and Bupivacaine and Dexmedetomidine in people with Anesthesia, run by Benha 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 7 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 4 Sep 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 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.
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?
the duration of sensory block (time frame: after anesthesia up to 12 hours postoperatively). 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 4 Sep 2026.