Postoperative PainPhase 4NCT06315634
Intrathecal Dexmedetomidine vs Midazolame
A Phase 4 study testing Dexmedetomidine, Midazolam and Bupivacain in people with Postoperative Pain, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexmedetomidine, Midazolam and Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2021to 10 Mar 2022
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing lower limb orthopedic cancer surgery.
- ASA I, II, III.
- Age 20 to 70 year
- Healthy volunteers
Who cannot join
- Age less than 20 and older than 70.
- ASA IV, V.
- patients' refusal.
- patients with coagulopathy.
- patients with severe valvular stenosis
- patients with infection at site of injection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
Read the detailed description
Comparison of intrathecal dexmedetomidine plus Bupivacaine vs intrathecal midazolam plus Bupivacaine on duration of sensory and motor blockade and hemodynamic parameters of patients
- Conditions
- Postoperative Pain
- Being tested
- Dexmedetomidine, Midazolam, Bupivacain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Spinal dexmedetomidine
5 micrograms intrathecal dexmedetomidine
MidazolamDrug
Also called Spinal midazolam
2 milligrams intrathecal midazolam
BupivacainDrug
Also called Spinal bupivacaine
12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Heavy Bupivacaine plus normal saline | Active comparator | 2.5 ml of 0.5% hyperbaric Bupivacaine plus 0.5 ml 0.9 % saline Receives: Drug: Bupivacain |
| Heavy Bupivacaine plus dexmedetomidine | Experimental | 2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline Receives: Drug: Dexmedetomidine; Drug: Bupivacain |
| Heavy Bupivacaine plus midazolam | Experimental | 2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline Receives: Drug: Midazolam; Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sensory block
Duration of sensory block after spinal anesthesia by the ability of the patient to demonstrate the pinprick sensation
Measured: 12 hours
Secondary outcomes (5)
Incidence of vomiting occurrence
The patient will be reported in case of vomiting occurrence
Measured: 12 hours
Sedation
Ramsay's sedation score1: anxious, agitated and restlessness, 2: oriented and cooperative, 3: responds to command only, 4: brisk response to loud voice and light glabellar tap, 5: sluggish to no response to light glabellar tap or loud auditory stimulus, 6: no response even to pain
Measured: 12 hours
Change in mean arterial blood pressure
Non invasive blood pressure measurement
Measured: 12 hours
Duration of motor block
Ability of patient to regain full motor power
Measured: 12 hours
Change in heart rate
Heart rate will be compared between the three groups and will be compared with baseline preoperative values in each group
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start15 Mar 2021
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said Nasef Zedan, National Cancer Institute, Egypt
- Investigators
- Mohamed Elwasef, MD, Study director, NCI Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315634
- Sponsor's protocol ID
- AP210330102
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2024
- Last updated
- 18 Mar 2024
- 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 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
- ClinicalTrials.gov ID
- NCT06315634
- Acronym / sponsor ID
- AP210330102
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 18 Mar 2024 (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.
Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
Detailed description
Comparison of intrathecal dexmedetomidine plus Bupivacaine vs intrathecal midazolam plus Bupivacaine on duration of sensory and motor blockade and hemodynamic parameters of patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heavy Bupivacaine plus normal saline | Active comparator | Drug: Bupivacain2.5 ml of 0.5% hyperbaric Bupivacaine plus 0.5 ml 0.9 % saline |
| Heavy Bupivacaine plus dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: Bupivacain2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline |
| Heavy Bupivacaine plus midazolam | Experimental | Drug: Midazolam, Drug: Bupivacain2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing lower limb orthopedic cancer surgery.
- ASA I, II, III.
- Age 20 to 70 year
- Healthy volunteers
Key exclusion criteria (6 listed)
- Age less than 20 and older than 70.
- ASA IV, V.
- patients' refusal.
- patients with coagulopathy.
- patients with severe valvular stenosis
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: Spinal dexmedetomidine5 micrograms intrathecal dexmedetomidine | Drug | Heavy Bupivacaine plus dexmedetomidine |
| MidazolamAlso: Spinal midazolam2 milligrams intrathecal midazolam | Drug | Heavy Bupivacaine plus midazolam |
| BupivacainAlso: Spinal bupivacaine12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine | Drug | Heavy Bupivacaine plus dexmedetomidine, Heavy Bupivacaine plus midazolam, Heavy Bupivacaine plus normal saline |
Primary outcome
Duration of sensory block
Time frame: 12 hours
Duration of sensory block after spinal anesthesia by the ability of the patient to demonstrate the pinprick sensation
5 secondary outcomes
Incidence of vomiting occurrence
Time frame: 12 hours
Sedation
Time frame: 12 hours
Change in mean arterial blood pressure
Time frame: 12 hours
Duration of motor block
Time frame: 12 hours
Change in heart rate
Time frame: 12 hours
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 18 Mar 2024.
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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.
Mohamed Elwasef, MD study director
NCI Egypt
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, Midazolam and Bupivacain in people with Postoperative Pain, run by National Cancer Institute, Egypt 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 18 Mar 2024. 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?
Duration of sensory block (time frame: 12 hours). 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 18 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.