HypotensionPhase 1NCT05880693
Comparisons Between Dexmedetomidine and Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries
A Phase 1 study testing Dexmedetomidine and Magnesium sulfate in people with Hypotension, run by mohamed at 1 site in Egypt.
Trial summary
General anesthesia organizes the best option for controlled blood pressure during rhinoplasty surgery. The primary agent applied in controlling hypotension should have particular unique characteristics. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension
- What is being tested?
- Dexmedetomidine and Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 May 2023
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 years old
- ASA (American Society of Anesthesiologists) grading I and II
- patients undergo rhinoplasty surgery under general anesthesia
Who cannot join
- The pregnant ladies
- patients suffering from hypertension ischemic heart diseases renal insufficiency, neuromuscular diseases, hepatic impairment
- cerebrovascular inadequacy and diabetic neuropathy, coagulopathies,
- patients taking antiplatelets
- Refused study,
- patients of age < 18 or > 60 were unauthorized from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries
General anesthesia organizes the best option for controlled blood pressure during rhinoplasty surgery. The primary agent applied in controlling hypotension should have particular unique characteristics. The dexmedetomidine central and peripheral sympatholytic performance is usually indicated by low blood pressure and low heart rate. magnesium sulfate is among the best agents used.
Read the detailed description
This is a prospective comparative randomized study. 56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality. The amount of blood loss during the entire process was measured. The score of pain was evaluated using the NRS rating scale. Sedation score through Ramsey sedation score. The time required for the first requirement of analgesia was also recorded as well as intraoperative and postoperative problems.
- Conditions
- Hypotension
- Being tested
- Dexmedetomidine, Magnesium sulfate
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called magnesium sulfate
Group 1 received dexmedetomidine
Magnesium sulfateDrug
the group 2 received magnesium sulfate
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | The first group (group 1): (n= 28): Received a loading dose of dexmedetomidine 1 μg/kg in a normal saline 0.9% solution of 100 ml 10 minutes before anesthesia induction and then a 0.4 ug/kg/h via syringe infusion pump during the time of surgery.
. Receives: Drug: Dexmedetomidine |
| group 2 | Experimental | The second group (group 2): (n= 28): Received magnesium sulfate 30 mg/kg as a loading dose in a saline 0.9% solution of 100 ml infusion through the syringe pump10 minutes before anesthesia induction and then a 10 mg/kg/h via syringe infusion pump during the time of surgery Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was to determine the bleeding score
The primary outcome was to determine the bleeding score, the secondary outcomes included the mean arterial pressure as well as heart rate aiming to arrive at a surgical field free from the blood through controlled Hypotension, determination of surgeon satisfaction, and operation time, they also aided in anesthesia recovery through the use of the Aldrete score, Ramsey sedation score, and the first analgesia postoperative requirement.
Measured: 24 hours postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Jan 2022
- Primary completion1 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor-investigator, mohamed, Al-Azhar University
- Investigators
- Mohamed GA aboelsuod, Principal investigator, AZHAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880693
- Sponsor's protocol ID
- Sameh
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 31 May 2023
- 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 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries
- ClinicalTrials.gov ID
- NCT05880693
- Acronym / sponsor ID
- Sameh
- Conditions
- Hypotension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- mohamedUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 30 May 2023 (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.
General anesthesia organizes the best option for controlled blood pressure during rhinoplasty surgery. The primary agent applied in controlling hypotension should have particular unique characteristics. The dexmedetomidine central and peripheral sympatholytic performance is usually indicated by low blood pressure and low heart rate. magnesium sulfate is among the best agents used.
Detailed description
This is a prospective comparative randomized study. 56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality. The amount of blood loss during the entire process was measured. The score of pain was evaluated using the NRS rating scale. Sedation score through Ramsey sedation score. The time required for the first requirement of analgesia was also recorded as well as intraoperative and postoperative problems.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality.
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: DexmedetomidineThe first group (group 1): (n= 28): Received a loading dose of dexmedetomidine 1 μg/kg in a normal saline 0.9% solution of 100 ml 10 minutes before anesthesia induction and then a 0.4 ug/kg/h via syringe infusion pump during the time of surgery. . |
| group 2 | Experimental | Drug: Magnesium sulfateThe second group (group 2): (n= 28): Received magnesium sulfate 30 mg/kg as a loading dose in a saline 0.9% solution of 100 ml infusion through the syringe pump10 minutes before anesthesia induction and then a 10 mg/kg/h via syringe infusion pump during the time of surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years old
- ASA (American Society of Anesthesiologists) grading I and II
- patients undergo rhinoplasty surgery under general anesthesia
Key exclusion criteria (6 listed)
- The pregnant ladies
- patients suffering from hypertension ischemic heart diseases renal insufficiency, neuromuscular diseases, hepatic impairment
- cerebrovascular inadequacy and diabetic neuropathy, coagulopathies,
- patients taking antiplatelets
- Refused study,
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: magnesium sulfateGroup 1 received dexmedetomidine | Drug | group 1 |
| Magnesium sulfatethe group 2 received magnesium sulfate | Drug | group 2 |
Primary outcome
The primary outcome was to determine the bleeding score
Time frame: 24 hours postoperative period
The primary outcome was to determine the bleeding score, the secondary outcomes included the mean arterial pressure as well as heart rate aiming to arrive at a surgical field free from the blood through controlled Hypotension, determination of surgeon satisfaction, and operation time, they also aided in anesthesia recovery through the use of the Aldrete score, Ramsey sedation score, and the first analgesia postoperative requirement.
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 31 May 2023.
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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 GA aboelsuod principal investigator
AZHAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine and Magnesium sulfate in people with Hypotension, run by mohamed 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 3 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 31 May 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The primary outcome was to determine the bleeding score (time frame: 24 hours postoperative period). 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 31 May 2023.