Pain, PostoperativeNCT04697745
Dexamethasone and Dexmedetomidine as an Adjuvant to Spinal Anesthesia for Elective Caesarean Sections
A study testing Intrathecal dexamethasone and Intrathecal dexmedetomidine in people with Pain, Postoperative, run by Benha University.
Trial summary
The main objective of our study is to evaluate analgesic effect of intrathecal dexamethasone and dexmedetomidine in elective caesarean sections Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Intrathecal dexamethasone and Intrathecal dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 30 May 2021
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old )
- Elective cesarean section under spinal anaesthesia
- Gestational age > 37 weeks
- BMI less than 30 kg/m2
Who cannot join
- Patient refusal
- unable to give consent
- age < 18 or > 40
- BMI more than 30 kg/m2
- known allergy to the study medication
- coagulopathies or on anticoagulant medications
- diabetic neuropathy
- patients with psychiatric disorders
About this study
Official title: Comparison Between Analgesic Effect of Dexamethasone and Dexmedetomidine as an Adjuvant to Bupivacaine for Spinal Anesthesia for Elective Caesarean Sections
The main objective of our study is to evaluate analgesic effect of intrathecal dexamethasone and dexmedetomidine in elective caesarean sections
- Conditions
- Pain, Postoperative
- Being tested
- Intrathecal dexamethasone, Intrathecal dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal dexamethasoneDrug
intrathecal adjuvants to bupivacaine
Intrathecal dexmedetomidineDrug
intrathecal adjuvants to bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone intrathecal | Active comparator | Not described Receives: Drug: Intrathecal dexamethasone |
| dexmedetomidine intrathecal | Active comparator | Not described Receives: Drug: Intrathecal dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic effect
Duration of sensory block and time to first analgesic rescue .
.
Measured: Up to 24 hours after surgery
Secondary outcomes (1)
intraoperative complications
Incidince of intraoperative shivering, nausea and vometing
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Mar 2021 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baher Said Elshahat Mohamed Abdelhady, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697745
- Sponsor's protocol ID
- adjuvant to spinal anesthesia
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 6 Jan 2021
- 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 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Analgesic Effect of Dexamethasone and Dexmedetomidine as an Adjuvant to Bupivacaine for Spinal Anesthesia for Elective Caesarean Sections
- ClinicalTrials.gov ID
- NCT04697745
- Acronym / sponsor ID
- adjuvant to spinal anesthesia
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 6 Jan 2021 (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 main objective of our study is to evaluate analgesic effect of intrathecal dexamethasone and dexmedetomidine in elective caesarean sections
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone intrathecal | Active comparator | Drug: Intrathecal dexamethasone |
| dexmedetomidine intrathecal | Active comparator | Drug: Intrathecal dexmedetomidine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old )
- Elective cesarean section under spinal anaesthesia
- Gestational age > 37 weeks
- BMI less than 30 kg/m2
Key exclusion criteria (8 listed)
- Patient refusal
- unable to give consent
- age < 18 or > 40
- BMI more than 30 kg/m2
- known allergy to the study medication
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 |
|---|---|---|
| Intrathecal dexamethasoneintrathecal adjuvants to bupivacaine | Drug | dexamethasone intrathecal |
| Intrathecal dexmedetomidineintrathecal adjuvants to bupivacaine | Drug | dexmedetomidine intrathecal |
Primary outcome
analgesic effect
Time frame: Up to 24 hours after surgery
Duration of sensory block and time to first analgesic rescue . .
1 secondary outcome
intraoperative complications
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal dexamethasone and Intrathecal dexmedetomidine in people with Pain, Postoperative, run by Benha University.
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 8 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
analgesic effect (time frame: Up to 24 hours after surgery). 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 6 Jan 2021.