Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function
Primary Purpose
the Effect of Intraoperative Magnesium Infusion on Postoperative Cognitive Functions in Adult Patients After Elective Pelvi-abdominal Surgeries
Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulfate
Sponsored by
About this trial
This is an interventional diagnostic trial for the Effect of Intraoperative Magnesium Infusion on Postoperative Cognitive Functions in Adult Patients After Elective Pelvi-abdominal Surgeries
Eligibility Criteria
Inclusion Criteria:
- Male and female patients (age 20-60 years)
- American Society of Anesthesiology(ASA) physical status I-II
- Patients scheduled for elective pelvi-abdominal surgeries
Exclusion Criteria:
- Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
- Patients with uncontrolled hypertension or diabetes
- History of hypersensitivity to the drugs to be used
- Control MMSE score ≤23
- Women who are pregnant or breastfeeding
- Patients taking Ca2+ channel blockers, opioids, antidepressants, or antipsychotics or alcohol
- Patients having difficulty understanding , vision or hearing problems or CNS disorder as parkinson's disease .
- Morbidly obese patients with a body mass index of >40
- Patients who refused to be involved within the scope of the research.
Sites / Locations
- Beni-Suef University HospitalRecruiting
- Faculty of Medicine, Beni-SuefUniversityRecruiting
- Faculty of Medicine,Beni-Suef UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
magnesium sulphate
Arm Description
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
Outcomes
Primary Outcome Measures
magnesium infusion on postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT04256057
First Posted
February 3, 2020
Last Updated
February 3, 2020
Sponsor
Beni-Suef University
1. Study Identification
Unique Protocol Identification Number
NCT04256057
Brief Title
Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function
Official Title
Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function After Pelvi-abdominal Surgeries :an Observational Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2020 (Anticipated)
Primary Completion Date
April 15, 2020 (Anticipated)
Study Completion Date
April 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef 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
The aimof this study is to observe the effect of intraoperative magnesium infusion on peri-operative pain and postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.
Detailed Description
This study will be conducted at Beni-Suef University Hospital after approval of the anesthesiology, surgical ICU and pain management department, and the local ethics and research committee, and obtaining written informed consents from the patients .
The inclusion criteria:
Male and female patients (age 20-60 years)
American Society of Anesthesiology(ASA) physical status I-II
Patients scheduled for elective pelvi-abdominal surgeries
The Exclusion criteria
Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
Patients with uncontrolled hypertension or diabetes
History of hypersensitivity to the drugs to be used
Control MMSE score ≤23
Women who are pregnant or breastfeeding
Patients taking Ca2+ channel blockers, opioids, antidepressants, or antipsychotics or alcohol
Patients having difficulty understanding , vision or hearing problems or CNS disorder as parkinson's disease .
Morbidly obese patients with a body mass index of >40
Patients who refused to be involved within the scope of the research. Management of the patients in the operation room All patients will be informed about the tests and written informed consent will be obtained from each of them. The MMSE will be applied. After arrival to the operation theater the monitors will be applied including will be applied including 5 leads ECG, non invasive arterial blood pressure and pulse oximetry. Urinary catheter will be inserted for urine output monitoring. Train of four (TOF) monitoring and Bispectral index (BIS) monitoring will be done in order to evaluate the depth of hypnosis (A-2000 Bispectral Index, Aspect Medical Systems, the Netherlands).
Following 100% oxygen of 5 L/min for 3 min, 1% lidocaine at 0.5 mg/kg will be given intravenously in order to prevent potential injection pain due to propofol and to suppress hemodynamic response to endotracheal intubation. Propofol 2 mg/kg, midazolam 0.03 mg/kg, fentanyl 3μg/kg and 0.6 mg /kg atracurium will be given followed by intubation and Mechanical ventilation with 6 mL/kg tidal volume and a frequency of 8-12/min with total of 4 L/min in 40% O2 air mixture to keep EtCO2 between 36 and 40 mmHg. Anesthesia will be maintained using oxygen and 1-1.5 minimum alveolar concentration (MAC) of isoflurane.
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery .24 In case of a patient with hypotension (mean arterial pressure ˂55 mmHg), 5 mg ephedrine will be injected so that the mean arterial pressure could reach higher than 55 mm Hg. If arrhythmia occured in any of the patients during operation, proper treatment will be be performed and the patient will be excluded from the study. The magnesium sulphate and anaesthetic agent infusions will be discontinued at skin closure. The relaxant effect of magnesium sulfate will be considered so train of four (TOF) monitoring will be used to monitor the muscle relaxation during the surgery and patients will be extubated at the end of the operation based on the TOF > 0.9 to ensure the complete reversal of relaxants by neostigmin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Effect of Intraoperative Magnesium Infusion on Postoperative Cognitive Functions in Adult Patients After Elective Pelvi-abdominal Surgeries
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
magnesium sulphate
Arm Type
Other
Arm Description
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
Primary Outcome Measure Information:
Title
magnesium infusion on postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.
Description
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
Time Frame
the observation will be for 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients (age 20-60 years)
American Society of Anesthesiology(ASA) physical status I-II
Patients scheduled for elective pelvi-abdominal surgeries
Exclusion Criteria:
Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
Patients with uncontrolled hypertension or diabetes
History of hypersensitivity to the drugs to be used
Control MMSE score ≤23
Women who are pregnant or breastfeeding
Patients taking Ca2+ channel blockers, opioids, antidepressants, or antipsychotics or alcohol
Patients having difficulty understanding , vision or hearing problems or CNS disorder as parkinson's disease .
Morbidly obese patients with a body mass index of >40
Patients who refused to be involved within the scope of the research.
Facility Information:
Facility Name
Beni-Suef University Hospital
City
Banī Suwayf
ZIP/Postal Code
6215
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samaa Rashwan, MD
Phone
0201270159125
Email
samaarashwan1971@gmail.com
Email
fom@med.bsu.edu.eg
Facility Name
Faculty of Medicine, Beni-SuefUniversity
City
Giza
ZIP/Postal Code
6125
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samaa Rashwan, MD
Phone
0201270159125
Email
samakassemrashwan@gmaail.com
Facility Name
Faculty of Medicine,Beni-Suef University
City
Giza
ZIP/Postal Code
: 62511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samaa Rashwan, MD
Phone
0201270159125
Email
samaarashwan1971@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function
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