Intraoperative Magnesium Sulfate Administration During Orthotopic Liver Transplantation
- Registration Number
- NCT03717467
- Lead Sponsor
- Fayoum University Hospital
- Brief Summary
The aim of study is to assess the effect of intraoperative use of magnesium sulfate in liver donating patients in reducing post-operative morphine requirements in early postoperative 24 hour in adult living liver donor.The authors hypothesize that magnesium sulfate can be used to efficiently reduce postoperative morphine consumption in the early 24 hours postoperatively as evident in other surgery types.
- Detailed Description
Introduction A lot of recent trials emphasized that perioperative magnesium sulfate (MgSO4) infusion has general anesthetic properties that could reduce anesthetic drug consumption and postoperative analgesia requirements in several types of surgery. Optimal post-operative pain control is necessary for early mobilization, improved respiratory function, and deep venous thrombosis. Administration of multimodal analgesics could limit the excessive use of systemic opioid analgesia especially (morphine), which has a high rate of postoperative side effects as sedation, respiratory depression, ileus, nausea, vomiting, constipation, urine retention, and itching. Therefore, medications and adjuvant drugs reducing the need for opioids have become widely used as parts of multimodal analgesia. Post-operative pain management begins with pre-operative planning and formulating a pain management plan that is tailored to an individual patient's liver function, respiratory and coagulation status, comorbidities and extent of resection.
Anesthetic technique:
Patients will be premedicated with tablet of alprazolam 0.25 mg the night before and 2 hours before surgery. Upon arrival in operating room usual monitoring will be established including heart rate, blood pressure, electrocardiogram (ECG),and temperature. After induction of anesthesia, an arterial line will be inserted for continuous monitoring of blood pressure and frequent blood gas analysis. End-tidal carbon dioxide (capnography) will be attached. General anesthesia will be administered using propofol 2 mg/kg, morphine 0.1 mg/kg and atracurium besylate 0.5 mg/kg followed by oral endotracheal intubation. Maintenance of general anesthesia with a mixture of isoflurane and 50% oxygen in air, morphine 2 mg/ h, mechanical ventilation will be adjusted to keep arterial oxygen saturation \< 95 % and end-tidal carbon dioxide between 35 and 40 mmHg. Atracurium (0.15 mg/kg) will be administered every 30 min.
Baseline intravenous infusion rate of lactated ringers solution will be set at (6ml/ kg/h) in both groups, additional solution will be infused if required. Magnesium sulfate infusion and anesthetic agents will be discontinued at the end of operation. The postoperative residual neuromuscular blockade will be reversed by using neostigmine 0.04 mg/kg and atropine 0.02 mg/kg. Then the patient will be extubated and transferred to the post-anesthesia care unit (PACU) for 1-hour observation.
Statistical analysis:
Statistical analysis will be done using Statistical Package for Social Sciences (SPSS) version 19 for Windows software. Data will be collected from all patients during and after anesthesia. Descriptive statistics (mean, standard deviation, or median and ranges) will be calculated. Comparative statistics between the two groups will be applied. Unpaired t-test will be used to compare the mean values between the two groups. The Kolmogorov-Smirnov test will be implemented to check the normality of continuous data distribution (P ≤ 0.05) Mann-Whitney-U test will be used to compare difference between the two groups for non-parametric variables (e.g.VAS). While the Chi-square test will be used to compare the categorical variables between both groups. The significant result will be considered when P value was less than (0.05).
Sample size calculations of this trial will be done upon the following assumption, α = 0.05 β = 0.2, effect size will be =0.7.The effect size is calculated by using G\*Power software version 3.1.9.2 (Institute of Experimental Psychology, Heinrich Heine University, Dusseldorf, German) and the authors found that 25 patients in each group have a power of 80% and plan to recruit 30 patients per group to account for possible dropout.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Age (18-50).
- American Society of Anesthesiology (ASA) physical state I or II.
- Normal serum electrolytes.
- Impaired hepatic or renal functions.
- Various degree of heart block.
- Hypertension
- Diabetes
- Myopathy or any neurological disorder.
- History of long term opioid use
- Patients treated with calcium channel blockers
- Patients with known allergy to drug used.
- Pregnant woman
- Obesity (Body Mass Index > 30).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S group isotonic saline Isotonic saline as placebo will be given. M group Magnesium Sulfate Magnesium sulfate will be given
- Primary Outcome Measures
Name Time Method Postoperative Morphine consumption 24 hours after operation in mg
- Secondary Outcome Measures
Name Time Method Interleukin 8 level in blood 24 hours after operation inflammatory mediator measured from venous blood sample
Mean arterial pressure 48 hours after end of surgery in mm mercury by invasive blood pressure
Assessment of sedation 48 hours after end of surgery By 5-point sedation Ramsay score where 5:aroused only by shaking 4:difficult response to verbal 3:mostly sleeping but easily aroused 2:drowsy 1:awake
Tumor necrosis factor alpha level in blood 24 hours after operation inflammatory mediator measured from venous blood sample
Incidence of respiratory depression 48 hours after operation as opioid related side effect
Incidence of oversedation 48 hours after operation as opioid related side effect
Incidence of itching 48 hours after operation as opioid related side effect
Incidence of paralytic ileus 48 hours after operation as opioid related side effect
Heart rate 48 hours after end of surgery in beat per minute by electrocardiogram
Patient satisfaction level 48 hours after end of surgery By 5-point scale where 1: very unsatisfactory 2:unsatisfactory 3:neutral 4:satisfactory 5:Excellent
Interleukin 6 level in blood 24 hours after operation inflammatory mediator measured from venous blood sample
Incidence of somnolence 48 hours after operation as opioid related side effect
Morphine consumption 48 hours after end of surgery in milligram
Visual Analog Scale 48 hours after end of surgery Pain score which starting from 0:no pain to 10:Worst pain
Blood serum magnesium concentration 15 minutes after operation from venous blood sample in mg/dl
Incidence of shivering 48 hours after operation as opioid related side effect
Incidence of vomiting 48 hours after operation as opioid related side effect
Incidence of nausea 48 hours after operation as opioid related side effect
Incidence of constipation 48 hours after operation as opioid related side effect
Trial Locations
- Locations (1)
Sheikh Zayed hospital
🇪🇬Giza, Egypt
Sheikh Zayed hospital🇪🇬Giza, EgyptHany M Yassin, MDContact1111363602hmy00@fayoum.edu.egYasser S Mostafa, MDContact1010509735ysm03@fayoum.edu.eg