Effects Magnesium Sulfate and Labetalol Infusion on Peripheral Perfusion and Pain in Nasal Surgeries
Primary Purpose
Peripheral Perfusion, Postoperative Pain
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulfate Injection
Labetalol Injectable Solution
Sponsored by
About this trial
This is an interventional prevention trial for Peripheral Perfusion
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Alshaimaa Abdel Fattah Kamel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Magnesium sulfate infudsion
Labetalol infusion
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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%)
Secondary Outcome Measures
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.
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.
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.
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.
Total pethidine requirements
Total pethidine requirements
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
Full Information
NCT ID
NCT04688203
First Posted
December 20, 2020
Last Updated
February 23, 2022
Sponsor
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT04688203
Brief Title
Effects Magnesium Sulfate and Labetalol Infusion on Peripheral Perfusion and Pain in Nasal Surgeries
Official Title
Effects of Magnesium Sulfate and Labetalol Infusion Used for Induced Hypotension on Peripheral Perfusion and Postoperative Pain in Nasal Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Perfusion, Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium sulfate infudsion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Labetalol infusion
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate Injection
Other Intervention Name(s)
magnesium sulfate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Labetalol Injectable Solution
Other Intervention Name(s)
labetalol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peripheral perfusion index
Description
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%)
Time Frame
Changes from baseline Peripheral perfusion index at 2 hours.
Secondary Outcome Measure Information:
Title
Mean arterial blood pressure
Description
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.
Time Frame
basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery
Title
Heart rate
Description
Heart rate will be recorded at basal, 3 minutes after intubation, and after skin incision then every 10 min till the end of surgery.
Time Frame
basal then at 3 minutes after intubation, and after skin incision then every 10 minutes till the end of surgery
Title
postoperative Pain intensity
Description
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.
Time Frame
at 30 minutes, 1 hour, 2hours, 4hours, 6hours, 12hours, and 24hours postoperative.
Title
time to first call for pethidine (rescue analgesic)
Description
Time from the stoppage of infusion solution to first call for pethidine (rescue analgesic) will be recorded.
Time Frame
up to 24hour postoperative
Title
Total pethidine requirements
Description
Total pethidine requirements
Time Frame
up to 24hour postoperative
Title
Serum lactate level
Description
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
Time Frame
basal and at one hour after extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshaimaa Kamel, M.D
Organizational Affiliation
Faculty of Human medicine, Zagazig university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alshaimaa Abdel Fattah Kamel
City
Zagazig
ZIP/Postal Code
002055
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
35986325
Citation
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.
Results Reference
derived
Learn more about this trial
Effects Magnesium Sulfate and Labetalol Infusion on Peripheral Perfusion and Pain in Nasal Surgeries
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