Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function
1 other identifier
interventional
24
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Mar 2020
Shorter than P25 for early_phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
March 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2020
CompletedFebruary 5, 2020
February 1, 2020
1 month
February 3, 2020
February 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
the observation will be for 24 hours
Study Arms (1)
magnesium sulphate
OTHERAfter 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Male and female patients (age 20-60 years)
- American Society of Anesthesiology(ASA) physical status I-II
- Patients scheduled for elective pelvi-abdominal surgeries
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Beni-Suef University Hospital
Banī Suwayf, 6215, Egypt
Faculty of Medicine, Beni-SuefUniversity
Giza, 6125, Egypt
Faculty of Medicine,Beni-Suef University
Giza, : 62511, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Samaa Abou Alkassem Rashwan
Study Record Dates
First Submitted
February 3, 2020
First Posted
February 5, 2020
Study Start
March 15, 2020
Primary Completion
April 15, 2020
Study Completion
April 15, 2020
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share