Mean Arterial PressureEarly Phase 1NCT06621004
Low Dose Magnesium Sulphate
A Early Phase 1 study testing Patients will receive propranolol 1-2 mg. and Patient receives magnesium sulphate in people with Mean Arterial Pressure, run by Ain Shams University at 1 site in Egypt.
Trial summary
This clinical trial aims to compare Patients who receive propranolol 1-2 mg to Patients who receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mg/kg to see if IV magnesium can stability mean arterial blood pressure and heart rate in patients undergoing nasal surgeries as well as the quality of… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Mean Arterial Pressure
- What is being tested?
- Patients will receive propranolol 1-2 mg. and Patient receives magnesium sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2024to 31 Jan 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing rhinoplasty or functional endoscopic sinus surgery (FESS) operation under general anesthesia
- ASA I or II
- Duration of surgery will be 1-2 hours
Who cannot join
- Hypertension,
- Myasthenia gravis or other muscular disease,
- Impaired kidney or liver functions,
- History of drug or alcohol abuse,
- History of antidepressant and calcium channel blocker use,
- Mental retardation and hysterical patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Low Dose Magnesium Sulphate in Nasal Surgery
This clinical trial aims to compare Patients who receive propranolol 1-2 mg to Patients who receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mg/kg to see if IV magnesium can stability mean arterial blood pressure and heart rate in patients undergoing nasal surgeries as well as the quality of postoperative analgesia, degree of sedation mean arterial blood pressure and HR will be recorded intraoperative and Participants will be asked to rate the pain at the first, second, fourth, sixth and 24th postoperative hour using the VAS score.
- Analgesic requirements: The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded.
- Sedation score: the degree of sedation will be assessed using the Ramsy sedation score
Read the detailed description
This prospective, randomized controlled clinical trial aims to establish the effect of magnesium sulphate during nasal surgery regarding deliberate hypotension, postoperative analgesia and sedation with minimal side effects.
this study will be conducted in the plastic surgery and ENT operating rooms at ASUH 130 patients undergoing rhinoplasty or functional endoscopic sinus surgery (FESS) operation under general anaesthesia.
patients will be allocated into 2 groups 65 patients each using a computer-generated randomization list.
Group (P): Patients will receive propranolol 1-2 mg. Group (PM): Patients will receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mg/kg.
- ABP and HR are continuously monitored and will be recorded before the start of anaesthesia (T1), after intubation (T2), at skin incision (T3), at manipulation of nasal bones (T4), at extubation (T5), before discharge to PACU (T6), and after 30 min in PACU.
- Surgical duration (time from skin incision till skin closure).
- Extubation time (from the end of anaesthesia to extubation)
- Modified Alderete score will be assessed and recorded every 5 minutes until discharge. Patients will be discharged upon achieving an Aldrete score of ≥ 9.
- The time to discharge will be recorded.
- VAS score for pain:
- Analgesic requirements: The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded.
- Sedation score: the degree of sedation will be assessed using the Ramsy sedation score where all be recorded
- Conditions
- Mean Arterial Pressure
- Being tested
- Patients will receive propranolol 1-2 mg., Patient receives magnesium sulphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will receive propranolol 1-2 mg.Drug
Patients will receive propranolol 1-2 mg. prepared in a 10 ml syringe (100 ug/ml).
Patient receives magnesium sulphateDrug
Magnesium sulphate 10%: 1g ampoule (10ml), will be prepared in a syringe pump to be given at a rate of 40 ml/hr . Another syringe of 10 ml 0.9% sodium chloride will be prepared to be given in group (P).
| Study group | Role | What they receive |
|---|---|---|
| propranolol | Active comparator | 1 mg propranolol will be prepared in a 10 ml syringe (100 ug/ml). Propranolol will be given 200-300 ug bolus followed by increments of 100 ug until MABP becomes 50-60 mmHg and HR 50 - 70 b/ m. Receives: Drug: Patients will receive propranolol 1-2 mg. |
| propranolol and magnesium sulphate | Active comparator | 1g MgSo3 ampoule (10ml) will be prepared in a syringe pump to be given at a rate of 40 ml/hr in the group and 1 mg propranolol will be prepared in a 10 ml syringe (100 ug/ml). Propranolol will be given 200-300 ug bolus followed by increments of 100 ug until MABP becomes 50-60 mmHg and HR 50 - 70 b/ m. Receives: Drug: Patients will receive propranolol 1-2 mg.; Drug: Patient receives magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial blood pressure
mmHg
Measured: intraoperative
Secondary outcomes (1)
analgesia
Visual analogue score
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start25 Aug 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mean Arterial PressureStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, MD, Ain Shams University
- Investigators
- Rania M Hussien, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621004
- Sponsor's protocol ID
- FMASU R205/2024
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Magnesium Sulphate in Nasal Surgery
- ClinicalTrials.gov ID
- NCT06621004
- Acronym / sponsor ID
- FMASU R205/2024
- Conditions
- Mean Arterial Pressure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 1 Oct 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.
This clinical trial aims to compare Patients who receive propranolol 1-2 mg to Patients who receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mg/kg to see if IV magnesium can stability mean arterial blood pressure and heart rate in patients undergoing nasal surgeries as well as the quality of postoperative analgesia, degree of sedation mean arterial blood pressure and HR will be recorded intraoperative and Participants will be asked to rate the pain at the first, second, fourth, sixth and 24th postoperative hour using the VAS score.
- Analgesic requirements: The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded.
- Sedation score: the degree of sedation will be assessed using the Ramsy sedation score
Detailed description
This prospective, randomized controlled clinical trial aims to establish the effect of magnesium sulphate during nasal surgery regarding deliberate hypotension, postoperative analgesia and sedation with minimal side effects.
this study will be conducted in the plastic surgery and ENT operating rooms at ASUH 130 patients undergoing rhinoplasty or functional endoscopic sinus surgery (FESS) operation under general anaesthesia.
patients will be allocated into 2 groups 65 patients each using a computer-generated randomization list.
Group (P): Patients will receive propranolol 1-2 mg. Group (PM): Patients will receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mg/kg.
- ABP and HR are continuously monitored and will be recorded before the start of anaesthesia (T1), after intubation (T2), at skin incision (T3), at manipulation of nasal bones (T4), at extubation (T5), before discharge to PACU (T6), and after 30 min in PACU.
- Surgical duration (time from skin incision till skin closure).
- Extubation time (from the end of anaesthesia to extubation)
- Modified Alderete score will be assessed and recorded every 5 minutes until discharge. Patients will be discharged upon achieving an Aldrete score of ≥ 9.
- The time to discharge will be recorded.
- VAS score for pain:
- Analgesic requirements: The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded.
- Sedation score: the degree of sedation will be assessed using the Ramsy sedation score where all be recorded
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propranolol | Active comparator | Drug: Patients will receive propranolol 1-2 mg.1 mg propranolol will be prepared in a 10 ml syringe (100 ug/ml). Propranolol will be given 200-300 ug bolus followed by increments of 100 ug until MABP becomes 50-60 mmHg and HR 50 - 70 b/ m. |
| propranolol and magnesium sulphate | Active comparator | Drug: Patients will receive propranolol 1-2 mg., Drug: Patient receives magnesium sulphate1g MgSo3 ampoule (10ml) will be prepared in a syringe pump to be given at a rate of 40 ml/hr in the group and 1 mg propranolol will be prepared in a 10 ml syringe (100 ug/ml). Propranolol will be given 200-300 ug bolus followed by increments of 100 ug until MABP becomes 50-60 mmHg and HR 50 - 70 b/ m. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients undergoing rhinoplasty or functional endoscopic sinus surgery (FESS) operation under general anesthesia
- ASA I or II
- Duration of surgery will be 1-2 hours
Key exclusion criteria (6 listed)
- Hypertension,
- Myasthenia gravis or other muscular disease,
- Impaired kidney or liver functions,
- History of drug or alcohol abuse,
- History of antidepressant and calcium channel blocker use,
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 |
|---|---|---|
| Patients will receive propranolol 1-2 mg.Patients will receive propranolol 1-2 mg. prepared in a 10 ml syringe (100 ug/ml). | Drug | propranolol, propranolol and magnesium sulphate |
| Patient receives magnesium sulphateMagnesium sulphate 10%: 1g ampoule (10ml), will be prepared in a syringe pump to be given at a rate of 40 ml/hr . Another syringe of 10 ml 0.9% sodium chloride will be prepared to be given in group (P). | Drug | propranolol and magnesium sulphate |
Primary outcome
mean arterial blood pressure
Time frame: intraoperative
mmHg
1 secondary outcome
analgesia
Time frame: 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Rania M Hussien principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Patients will receive propranolol 1-2 mg. and Patient receives magnesium sulphate in people with Mean Arterial Pressure, run by Ain Shams 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 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: enrolling by invitation, as of the sponsor's last update on 9 Oct 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
mean arterial blood pressure (time frame: intraoperative). 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 9 Oct 2024.