Cesarean SectionNCT06785285
Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section
A study testing Dexmedetomidine in people with Cesarean Section, run by Sohag University at 1 site in Egypt.
Trial summary
The quality of the spinal anesthesia has beenreported to be improved by the addition of opioids (such as morphine, fentanyl and sufentanil) and other drugs (such as dexmedetomidine, clonidine, magnesium sulfate (Mg), neostigmine, ketamine, and midazolam). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 10 Oct 2024
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women in the childbearing period
- aged 18 to 40 years
- Gestational age ≥37 weeks of pregnancy
- ASA I and II candidates for elective cesarean section under spinal anesthesia.
Who cannot join
- The patients with emergency conditions,
- Contraindication of spinal anesthesia,
- History of valvular heart disease,
- History of allergy or sensitivity to applied drugs and
- Patients with placenta previa
- Failed blockade or need for induction of general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
The quality of the spinal anesthesia has beenreported to be improved by the addition of opioids (such as morphine, fentanyl and sufentanil) and other drugs (such as dexmedetomidine, clonidine, magnesium sulfate (Mg), neostigmine, ketamine, and midazolam).
Opioids such as fentanyl in combination with bupivacaine improvesthe quality of intraoperative and early postoperative subarachnoid block. Although, fentanylensures superior quality of analgesia, it is associated with many side effects. This has directed theresearch toward the use of newer and betteradjuvants for spinal anesthesia such as clonidineand dexmedetomidine
Read the detailed description
Spinal anesthesia is still the first choice for cesarean section due to its deep sensoryblock as well as fewer side effects on mother and fetus. Despite many benefits ofthismethod, it has a short duration and cannot provide sufficient postoperativeanalgesia.Adequate postoperative analgesia plays a crucial role in cesarean delivery because itallows better breastfeeding and caring for newborns.
Dexmedetomidine is a relatively newer highly selectivealpha-2 adrenoceptor agonist agent that producesanalgesic and sedative effects. It has also been used asan adjuvant in Spinal anesthesia resulting in prolonged duration ofblock and improved postoperative analgesia without anyassociated hypotension or other adverse events
Fentanyl is a synthetic opioid with central action,which is used widely for pain control. Intrathecal fentanyl is usually added to other local anesthetics to increase anesthesia and analgesia. It has improved spinal anesthesia and reduced the anesthetic drug-related side effects including pruritus,nausea, and vomiting.
Adjuvant drugs added to the intrathecal bupivacaine can decrease the dose of local anesthetics and guarantee sensory and motor block. Intrathecal adjuvants include fentanyl and dexmedetomidine as receptor agonists, which have sedative, analgesic, perioperative sympatholytic, anesthetic-sparing, and hemodynamic-stabilizing properties.
- Conditions
- Cesarean Section
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called fentanyl 25 ug
To compare the effects of fentanyl and dexmedetomidine when used as adjuvants to intrathecal bupivacaine in elective cesarean section, assessing their impact on the onset and duration of spinal anesthesia, quality of analgesia, hemodynamic stability, incidence of side effects, and neonatal outcomes
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | About 30 patients received Dexmeditomidine 5 ug and added to it 10 mg hyperbaric bupivicaine 0.5 % . Receives: Drug: Dexmedetomidine |
| Group B | Active comparator | About 30 patients received fentanyl 25 ug and added to it 10 mg hyperbaric bupivicaine 0.5 % . Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief
Patient's pain score will be assessed using visual analogue scale (VAS); scored from 0-10 (where 0=no pain and 10=the worst pain imaginable) during the recovery room (T0) and at one, three, and six hours (T1, T3, and T6) in the postoperative period.
Measured: from 0 hours to 6 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start1 Mar 2024
- Primary completion1 Oct 2024
- Study completion10 Oct 2024
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 Sohag 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Samir Esmail, Sohag University
- Investigators
- Nehal samir esmail, Lecturer, Principal investigator, Sohag University, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785285
- Sponsor's protocol ID
- Nehal Samir
- Status last verified
- Mar 2024
- First submitted
- 27 Nov 2024
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section
- ClinicalTrials.gov ID
- NCT06785285
- Acronym / sponsor ID
- Nehal Samir
- Conditions
- Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 21 Jan 2025 (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 quality of the spinal anesthesia has beenreported to be improved by the addition of opioids (such as morphine, fentanyl and sufentanil) and other drugs (such as dexmedetomidine, clonidine, magnesium sulfate (Mg), neostigmine, ketamine, and midazolam).
Opioids such as fentanyl in combination with bupivacaine improvesthe quality of intraoperative and early postoperative subarachnoid block. Although, fentanylensures superior quality of analgesia, it is associated with many side effects. This has directed theresearch toward the use of newer and betteradjuvants for spinal anesthesia such as clonidineand dexmedetomidine
Detailed description
Spinal anesthesia is still the first choice for cesarean section due to its deep sensoryblock as well as fewer side effects on mother and fetus. Despite many benefits ofthismethod, it has a short duration and cannot provide sufficient postoperativeanalgesia.Adequate postoperative analgesia plays a crucial role in cesarean delivery because itallows better breastfeeding and caring for newborns.
Dexmedetomidine is a relatively newer highly selectivealpha-2 adrenoceptor agonist agent that producesanalgesic and sedative effects. It has also been used asan adjuvant in Spinal anesthesia resulting in prolonged duration ofblock and improved postoperative analgesia without anyassociated hypotension or other adverse events
Fentanyl is a synthetic opioid with central action,which is used widely for pain control. Intrathecal fentanyl is usually added to other local anesthetics to increase anesthesia and analgesia. It has improved spinal anesthesia and reduced the anesthetic drug-related side effects including pruritus,nausea, and vomiting.
Adjuvant drugs added to the intrathecal bupivacaine can decrease the dose of local anesthetics and guarantee sensory and motor block. Intrathecal adjuvants include fentanyl and dexmedetomidine as receptor agonists, which have sedative, analgesic, perioperative sympatholytic, anesthetic-sparing, and hemodynamic-stabilizing properties.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: DexmedetomidineAbout 30 patients received Dexmeditomidine 5 ug and added to it 10 mg hyperbaric bupivicaine 0.5 % . |
| Group B | Active comparator | Drug: DexmedetomidineAbout 30 patients received fentanyl 25 ug and added to it 10 mg hyperbaric bupivicaine 0.5 % . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women in the childbearing period
- aged 18 to 40 years
- Gestational age ≥37 weeks of pregnancy
- ASA I and II candidates for elective cesarean section under spinal anesthesia.
Key exclusion criteria (6 listed)
- The patients with emergency conditions,
- Contraindication of spinal anesthesia,
- History of valvular heart disease,
- History of allergy or sensitivity to applied drugs and
- Patients with placenta previa
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: fentanyl 25 ugTo compare the effects of fentanyl and dexmedetomidine when used as adjuvants to intrathecal bupivacaine in elective cesarean section, assessing their impact on the onset and duration of spinal anesthesia, quality of analgesia, hemodynamic stability, incidence of side effects, and neonatal outcomes | Drug | Group A, Group B |
Primary outcome
Pain Relief
Time frame: from 0 hours to 6 hours after the procedure
Patient's pain score will be assessed using visual analogue scale (VAS); scored from 0-10 (where 0=no pain and 10=the worst pain imaginable) during the recovery room (T0) and at one, three, and six hours (T1, T3, and T6) in the postoperative period.
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 21 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
Not yet recruiting
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
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Implementation of a Disparities in Labor Outcomes Dashboard
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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.
Nehal samir esmail, Lecturer principal investigator
Sohag University, Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Cesarean Section, run by Sohag 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 4 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: finished, as of the sponsor's last update on 21 Jan 2025. 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.
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?
Pain Relief (time frame: from 0 hours to 6 hours after the procedure). 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 21 Jan 2025.