Peripheral PerfusionPhase 1/2NCT04688203
Effects Magnesium Sulfate and Labetalol Infusion on Peripheral Perfusion and Pain in Nasal Surgeries
A Phase 1/2 study testing Magnesium Sulfate Injection and Labetalol Injectable Solution in people with Peripheral Perfusion and Postoperative Pain, run by Zagazig University at 1 site in Egypt.
Trial summary
One of main risk of controlled hypotension during nasal surgeries is impaired perfusion. Peripheral perfusion of non-vital organs usually impaired earlier than vital organs. So, evaluation of perfusion of non-vital organ is considered to be adequate measure of patient safety during surgery. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Perfusion, Postoperative Pain
- What is being tested?
- Magnesium Sulfate Injection and Labetalol Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 30 Sep 2021
- Phase
- Phase 1/2
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent from the patient.
- Age: 21-45 years old.
- Sex: both sex (males or females).
- Physical status: ASA 1\& II.
- BMI = (20-30 kg/m2).
- Type of operations: elective nasal surgeries such as septoplasty, endoscopic sinus surgery and polypectomy.
- Duration of surgery ≤ two hours.
Who cannot join
- Altered mental state
- Patients on beta blocker or with known history of allergy to study drugs.
- Advanced hepatic, renal, cardiovascular or respiratory diseases.
- Diabetic patients.
- Patients receiving anticoagulants or on pain killers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Magnesium Sulfate and Labetalol Infusion Used for Induced Hypotension on Peripheral Perfusion and Postoperative Pain in Nasal Surgeries
One of main risk of controlled hypotension during nasal surgeries is impaired perfusion. Peripheral perfusion of non-vital organs usually impaired earlier than vital organs. So, evaluation of perfusion of non-vital organ is considered to be adequate measure of patient safety during surgery.
Many hypotensive agents such as dexmedetomidine, B blockers, magnesium sulfate and nitroglycerine had been used but we are in need to investigate its effects on peripheral perfusion.
Postoperative pain related to nasal surgeries due to surgical trauma itself which induces the release of inflammatory mediators from neuronal and immune cells resulting in peripheral and central sensitization significantly affects recovery of patients. Magnesium sulfate and labetalol have analgesic actions besides their hypotensive effects but with different mechanisms.
Read the detailed description
To compare between the effects of magnesium sulfate and labetalol infusion during induced hypotension on peripheral perfusion and postoperative pain in nasal surgeries
OBJECTIVES:
To measure peripheral perfusion index (PPI) as an indicator for peripheral perfusion To calculate the total postoperative rescue analgesic requirements.
Double -blind randomized comparative Clinical Study. All Patients will be randomly allocated into two equal groups (group M and Group L).
Using computer generated randomization table, each group will be 25 patients.
- Conditions
- Peripheral Perfusion, Postoperative Pain
- Being tested
- Magnesium Sulfate Injection, Labetalol Injectable Solution
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate InjectionDrug
Also called magnesium sulfate
will receive IV bolus dose of 40mg/kg magnesium sulfate in 100 ml saline solution over ten minutes then continuous infusion of 10-15mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.
Labetalol Injectable SolutionDrug
Also called labetalol
will receive IV bolus does of labetalol 0.25 mg/kg over ten minutes then continuous infusion of 0.5-1mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate infudsion | Active comparator | patients will receive IV bolus dose of 40mg/kg magnesium sulfate in 100 ml saline solution over ten minutes then continuous infusion of 10-15mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery. Receives: Drug: Magnesium Sulfate Injection |
| Labetalol infusion | Active comparator | will receive IV bolus does of labetalol 0.25 mg/kg over ten minutes then continuous infusion of 0.5-1mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery. Receives: Drug: Labetalol Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral perfusion index
Peripheral perfusion index by pulse oximertry will be measured at basal, 3minutes after induction, every 10 minutes till end of surgery. It will be calculated by dividing the pulsatile signal to nonpulsatile. The normal range is (0.02% -20%)
Measured: Changes from baseline Peripheral perfusion index at 2 hours.
Secondary outcomes (6)
Mean arterial blood pressure
Mean arterial blood pressure will be recorded at basal, 3 minutes after intubation, and after skin incision then every 10 min till the end of surgery.
Measured: basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery
Heart rate
Heart rate will be recorded at basal, 3 minutes after intubation, and after skin incision then every 10 min till the end of surgery.
Measured: basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery
postoperative Pain intensity
Postoperative Pain will be assessed using Numerical rating Scale (NRS) . A commonly used scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient will be instructed to make a mark along the line to represent the intensity of pain currently being experienced. NRS score 4 or more =pain. Paracetamol 1gm IV will be given every 6 hours as a protocol for pain management will be started at the end of surgery, and IV pethidine 1mg/kg (rescue analgesic) will be given if NRS >4.
Measured: at 30 minutes, 1 hour, 2hours, 4hours, 6hours, 12hours, and 24hours postoperative.
time to first call for pethidine (rescue analgesic)
Time from the stoppage of infusion solution to first call for pethidine (rescue analgesic) will be recorded.
Measured: up to 24hour postoperative
Total pethidine requirements
Total pethidine requirements
Measured: up to 24hour postoperative
Serum lactate level
Serum lactate will be recorded basal and at one hour after extubation. The normal serum lactate ranges from 4.5 to 19.8 mg/dL
Measured: basal and at one hour after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Feb 2021
- Primary completion1 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral PerfusionStudies of the same condition, open and under way.
- More trials run by Zagazig 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alshaimaa Abdel Fattah Kamel, Zagazig University
- Investigators
- Alshaimaa Kamel, M.D, Principal investigator, Faculty of Human medicine, Zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688203
- Sponsor's protocol ID
- 6601
- Status last verified
- Feb 2022
- First submitted
- 20 Dec 2020
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamel AAF, Medhat MM, Salem DAE, Naby SMA. Effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion and postoperative pain in nasal surgery: a randomized controlled trial. Patient Saf Surg. 2022 Aug 19;16(1):27. doi: 10.1186/s13037-022-00336-7.
PubMed 35986325
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnesium Sulfate and Labetalol Infusion Used for Induced Hypotension on Peripheral Perfusion and Postoperative Pain in Nasal Surgeries
- ClinicalTrials.gov ID
- NCT04688203
- Acronym / sponsor ID
- 6601
- Conditions
- Peripheral Perfusion, Postoperative Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 29 Dec 2020 (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.
One of main risk of controlled hypotension during nasal surgeries is impaired perfusion. Peripheral perfusion of non-vital organs usually impaired earlier than vital organs. So, evaluation of perfusion of non-vital organ is considered to be adequate measure of patient safety during surgery.
Many hypotensive agents such as dexmedetomidine, B blockers, magnesium sulfate and nitroglycerine had been used but we are in need to investigate its effects on peripheral perfusion.
Postoperative pain related to nasal surgeries due to surgical trauma itself which induces the release of inflammatory mediators from neuronal and immune cells resulting in peripheral and central sensitization significantly affects recovery of patients. Magnesium sulfate and labetalol have analgesic actions besides their hypotensive effects but with different mechanisms.
Detailed description
To compare between the effects of magnesium sulfate and labetalol infusion during induced hypotension on peripheral perfusion and postoperative pain in nasal surgeries
OBJECTIVES:
To measure peripheral perfusion index (PPI) as an indicator for peripheral perfusion To calculate the total postoperative rescue analgesic requirements.
Double -blind randomized comparative Clinical Study. All Patients will be randomly allocated into two equal groups (group M and Group L).
Using computer generated randomization table, each group will be 25 patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate infudsion | Active comparator | Drug: Magnesium Sulfate Injectionpatients will receive IV bolus dose of 40mg/kg magnesium sulfate in 100 ml saline solution over ten minutes then continuous infusion of 10-15mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery. |
| Labetalol infusion | Active comparator | Drug: Labetalol Injectable Solutionwill receive IV bolus does of labetalol 0.25 mg/kg over ten minutes then continuous infusion of 0.5-1mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent from the patient.
- Age: 21-45 years old.
- Sex: both sex (males or females).
- Physical status: ASA 1\& II.
- BMI = (20-30 kg/m2).
Key exclusion criteria (5 listed)
- Altered mental state
- Patients on beta blocker or with known history of allergy to study drugs.
- Advanced hepatic, renal, cardiovascular or respiratory diseases.
- Diabetic patients.
- Patients receiving anticoagulants or on pain killers.
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 |
|---|---|---|
| Magnesium Sulfate InjectionAlso: magnesium sulfatewill receive IV bolus dose of 40mg/kg magnesium sulfate in 100 ml saline solution over ten minutes then continuous infusion of 10-15mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery. | Drug | Magnesium sulfate infudsion |
| Labetalol Injectable SolutionAlso: labetalolwill receive IV bolus does of labetalol 0.25 mg/kg over ten minutes then continuous infusion of 0.5-1mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery. | Drug | Labetalol infusion |
Primary outcome
Peripheral perfusion index
Time frame: Changes from baseline Peripheral perfusion index at 2 hours.
Peripheral perfusion index by pulse oximertry will be measured at basal, 3minutes after induction, every 10 minutes till end of surgery. It will be calculated by dividing the pulsatile signal to nonpulsatile. The normal range is (0.02% -20%)
6 secondary outcomes
Mean arterial blood pressure
Time frame: basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery
Heart rate
Time frame: basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery
postoperative Pain intensity
Time frame: at 30 minutes, 1 hour, 2hours, 4hours, 6hours, 12hours, and 24hours postoperative.
time to first call for pethidine (rescue analgesic)
Time frame: up to 24hour postoperative
Total pethidine requirements
Time frame: up to 24hour postoperative
Serum lactate level
Time frame: basal and at one hour after extubation
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 24 Feb 2022.
- Derived from this study: PubMed 35986325Kamel AAF, Medhat MM, Salem DAE, Naby SMA. Effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion and postoperative pain in nasal surgery: a randomized controlled trial. Patient Saf Surg. 2022 Aug 19;16(1):27. doi: 10.1186/s13037-022-00336-7.
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Sepsis
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Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit
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Not yet recruitingObservational study
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Not yet recruitingPhase 4
Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery
Postoperative Pain, Caudal Anesthesia
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.
Alshaimaa Kamel, M.D principal investigator
Faculty of Human medicine, Zagazig university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Magnesium Sulfate Injection and Labetalol Injectable Solution in people with Peripheral Perfusion and Postoperative Pain, run by Zagazig 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 7 inclusion and 5 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 24 Feb 2022. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Peripheral perfusion index (time frame: Changes from baseline Peripheral perfusion index at 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04688203, which also lists 1 linked publication.
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 24 Feb 2022.