Epidural Analgesics for ComparisonPhase 4NCT04174872
Epidural Anesthesia for Gynecological Surgeries
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Epidural Analgesics for Comparison, run by Cairo University at 1 site in Egypt.
Trial summary
Regional anesthesia is the preferred mode of anesthesia for major abdominal surgeries in present times. Gynecological surgeries are often associated with severe pain requiring a well-planned analgesia regimen to ensure adequate patient-comfort, early mobilization, and to decrease stay time in the… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epidural Analgesics for Comparison
- What is being tested?
- Dexmedetomidine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 1 Jun 2021
- Phase
- Phase 4
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients of ASA I-II.
- Aged 18-55 years undergoing elective gynecological surgeries
Who cannot join
- Patient refusal.
- Patients with history of diabetes mellitus, cardiac disease, hypertension, chronic obstructive respiratory disease, coagulation abnormalities, spinal deformities, patients allergic to amide type of local anesthetics, localized skin sepsis, neurological disease, hepatic and renal diseases, peripheral neuropathy and psychiatric diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Surgical ICU, and Pain Management
Cairo, 11562
About this study
Official title: A Comparative Study Between Dexmedetomidine and Midazolam as Adjuvant to Bupivacaine During Epidural Anesthesia For Elective Gynecological Operations
Regional anesthesia is the preferred mode of anesthesia for major abdominal surgeries in present times. Gynecological surgeries are often associated with severe pain requiring a well-planned analgesia regimen to ensure adequate patient-comfort, early mobilization, and to decrease stay time in the hospital/post-anesthesia care unit (PACU) enabling patients to return to their normal activities quicker. Dexmedetomidine has been approved by Food and Drug Administration (FDA) as a short-term sedative for mechanically ventilated intensive care unit (ICU) patients as it has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. Epidural administration of preservative free midazolam induces antinociceptive effects in humans, when midazolam is added it acts through gamma amino-butyric acid (GABA) receptors and enhances the affinity of GABA receptors. Midazolam is involved in the release of endogenous opioids acting on spinal delta receptors so antinociceptive effects of morphine like substances are potentiated when epidural midazolam is added. Studies have revealed that use of epidural midazolam provides effective analgesia in adults. So, the present study will evaluate the additive analgesic effects of epidural midazolam in combination with bupivacaine in elective gynecologic surgeries and compare the results with the use of bupivacaine with dexmedetomidine and observe the quality of epidural anesthesia with occurrence of side effects.
- Conditions
- Epidural Analgesics for Comparison
- Being tested
- Dexmedetomidine, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
it has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. It is now being used as a neuraxial adjuvant that can be used as an effective adjuvant in epidural anaesthesia as it intensifys the motor block and prolongs the duration of postoperative analgesia.
MidazolamDrug
Midazolam has been reported to have a spinally mediated analgesic effect. Clinically, single-shot epidural or spinal administration of midazolam has been shown to have an analgesic effect on perioperative pain.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Other | It has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. It is now being used as a neuraxial adjuvant that can be used as an effective adjuvant in epidural anaesthesia as it intensifys the motor block and prolongs the duration of postoperative analgesia. Receives: Drug: Dexmedetomidine; Drug: Midazolam |
| Midazolam | Other | Midazolam has been reported to have a spinally mediated analgesic effect. Clinically, single-shot epidural or spinal administration of midazolam has been shown to have an analgesic effect on perioperative pain. Receives: Drug: Dexmedetomidine; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of sensory blockade
time interval from epidural injection of drugs to sensory blockade at T10
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Dec 2019
- Primary completion1 Feb 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural Analgesics for ComparisonStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Ali Abdelhaleem Abdelrahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174872
- Sponsor's protocol ID
- ME-2001
- Status last verified
- Aug 2021
- First submitted
- 18 Nov 2019
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Dexmedetomidine and Midazolam as Adjuvant to Bupivacaine During Epidural Anesthesia For Elective Gynecological Operations
- ClinicalTrials.gov ID
- NCT04174872
- Acronym / sponsor ID
- ME-2001
- Conditions
- Epidural Analgesics for Comparison
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 22 Nov 2019 (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.
Regional anesthesia is the preferred mode of anesthesia for major abdominal surgeries in present times. Gynecological surgeries are often associated with severe pain requiring a well-planned analgesia regimen to ensure adequate patient-comfort, early mobilization, and to decrease stay time in the hospital/post-anesthesia care unit (PACU) enabling patients to return to their normal activities quicker. Dexmedetomidine has been approved by Food and Drug Administration (FDA) as a short-term sedative for mechanically ventilated intensive care unit (ICU) patients as it has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. Epidural administration of preservative free midazolam induces antinociceptive effects in humans, when midazolam is added it acts through gamma amino-butyric acid (GABA) receptors and enhances the affinity of GABA receptors. Midazolam is involved in the release of endogenous opioids acting on spinal delta receptors so antinociceptive effects of morphine like substances are potentiated when epidural midazolam is added. Studies have revealed that use of epidural midazolam provides effective analgesia in adults. So, the present study will evaluate the additive analgesic effects of epidural midazolam in combination with bupivacaine in elective gynecologic surgeries and compare the results with the use of bupivacaine with dexmedetomidine and observe the quality of epidural anesthesia with occurrence of side effects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Other | Drug: Dexmedetomidine, Drug: MidazolamIt has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. It is now being used as a neuraxial adjuvant that can be used as an effective adjuvant in epidural anaesthesia as it intensifys the motor block and prolongs the duration of postoperative analgesia. |
| Midazolam | Other | Drug: Dexmedetomidine, Drug: MidazolamMidazolam has been reported to have a spinally mediated analgesic effect. Clinically, single-shot epidural or spinal administration of midazolam has been shown to have an analgesic effect on perioperative pain. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female patients of ASA I-II.
- Aged 18-55 years undergoing elective gynecological surgeries
Key exclusion criteria (2 listed)
- Patient refusal.
- Patients with history of diabetes mellitus, cardiac disease, hypertension, chronic obstructive respiratory disease, coagulation abnormalities, spinal deformities, patients allergic to amide type of local anesthetics, localized skin sepsis, neurological disease, hepatic and renal diseases, peripheral neuropathy and psychiatric diseases.
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: precedexit has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. It is now being used as a neuraxial adjuvant that can be used as an effective adjuvant in epidural anaesthesia as it intensifys the motor block and prolongs the duration of postoperative analgesia. | Drug | Dexmedetomidine, Midazolam |
| MidazolamMidazolam has been reported to have a spinally mediated analgesic effect. Clinically, single-shot epidural or spinal administration of midazolam has been shown to have an analgesic effect on perioperative pain. | Drug | Dexmedetomidine, Midazolam |
Primary outcome
Onset of sensory blockade
Time frame: Eight months
time interval from epidural injection of drugs to sensory blockade at T10
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 3 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Epidural Analgesics for Comparison, run by Cairo 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 2 inclusion and 2 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 3 Aug 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Onset of sensory blockade (time frame: Eight months). 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 3 Aug 2021.