Pre-EclampsiaPhase 2/3NCT03391609
Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients
A Phase 2/3 study testing Dexmedetomidine infusion in people with Pre-Eclampsia, run by Assiut University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the effects of dexmedetomidine infusion on the stress response to intubation, postoperative analgesia, and renal functions (urinary output [UOP], creatinine and glomerular filtration rate [GFR]) in preeclamptic patient. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Dexmedetomidine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jun 2017to 1 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 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women
- have mild preeclampsia ( Pre-eclamptic patients will be defined as having hypertension [systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP)≥90 mmHg] accompanied by proteinuria first detected after 20 weeks of gestation).
- Proteinuria is defined as at least 300 mg protein in 24 h urine collection [or ≥1+ dipstick (30 mg/dl) in a single urine sample] ).
- American Society of Anesthesiologists (ASA) physical status of II or III.
- age between 19 and 40 years
Who cannot join
- patient refusal to consent (obsolete).
- pre-existing neurological disease or psychic patients.
- history of cardiac and respiratory system failure.
- co-existing significant renal or liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-operative Dexmedetomidine Infusion in Mild Pre-eclamptic Patients Undergoing Elective Cesarean Section Under General Anesthesia
The purpose of this study is to investigate the effects of dexmedetomidine infusion on the stress response to intubation, postoperative analgesia, and renal functions (urinary output [UOP], creatinine and glomerular filtration rate [GFR]) in preeclamptic patient.
- Conditions
- Pre-Eclampsia
- Being tested
- placebo infusion, Dexmedetomidine infusion
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo infusionDrug
Caesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.
Dexmedetomidine infusionDrug
Caesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Caesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure. Receives: Drug: placebo infusion |
| Dex. group | Active comparator | Caesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure. Receives: Drug: Dexmedetomidine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesia
through VAS score readings
Measured: 24 hours postoperatively
Secondary outcomes (3)
stress response
mean arterial blood pressure
Measured: 24 hours postoperatively
renal function
glomerular filtration rate
Measured: 24 hours postoperatively
untoward events
eclampsia, drug side effects (over sedation, hypotension, bradycardia)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start18 Jun 2017
- Primary completion1 Nov 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mohammad Abd El-Rahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391609
- Sponsor's protocol ID
- 144
- Status last verified
- Feb 2019
- First submitted
- 18 Dec 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Dexmedetomidine Infusion in Mild Pre-eclamptic Patients Undergoing Elective Cesarean Section Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03391609
- Acronym / sponsor ID
- 144
- Conditions
- Pre-Eclampsia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 18 Jun 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 5 Jan 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 purpose of this study is to investigate the effects of dexmedetomidine infusion on the stress response to intubation, postoperative analgesia, and renal functions (urinary output [UOP], creatinine and glomerular filtration rate [GFR]) in preeclamptic patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: placebo infusionCaesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure. |
| Dex. group | Active comparator | Drug: Dexmedetomidine infusionCaesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pregnant women
- have mild preeclampsia ( Pre-eclamptic patients will be defined as having hypertension [systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP)≥90 mmHg] accompanied by proteinuria first detected after 20 weeks of gestation).
- Proteinuria is defined as at least 300 mg protein in 24 h urine collection [or ≥1+ dipstick (30 mg/dl) in a single urine sample] ).
- American Society of Anesthesiologists (ASA) physical status of II or III.
- age between 19 and 40 years
Key exclusion criteria (4 listed)
- patient refusal to consent (obsolete).
- pre-existing neurological disease or psychic patients.
- history of cardiac and respiratory system failure.
- co-existing significant renal or liver disease.
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 |
|---|---|---|
| placebo infusionCaesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure. | Drug | control group |
| Dexmedetomidine infusionCaesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure. | Drug | Dex. group |
Primary outcome
postoperative analgesia
Time frame: 24 hours postoperatively
through VAS score readings
3 secondary outcomes
stress response
Time frame: 24 hours postoperatively
renal function
Time frame: 24 hours postoperatively
untoward events
Time frame: 24 hours postoperatively
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 26 Feb 2019.
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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 infusion in people with Pre-Eclampsia, 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 4 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 26 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
postoperative analgesia (time frame: 24 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 26 Feb 2019.