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Intraoperative Magnesium Sulfate Administration During Orthotopic Liver Transplantation

The Influence of Intraoperative Magnesium Sulfate Administration on Postoperative Morphine Requirement in Living Donor During Orthotopic Liver Transplantation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717467
Enrollment
60
Registered
2018-10-24
Start date
2019-05-08
Completion date
2021-07-01
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Magnesium sulfate, Morphine requirement, Hepatotomy, Orthotopic liver transplantation

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.

Interventions

DRUGisotonic saline

100 ml of isotonic saline over 15 min immediately before induction of anesthesia and then 15 mg/kg/h by continuous I.V. infusion until the end of operation.

DRUGMagnesium Sulfate

40 mg/kg of magnesium sulfate in 100 ml of isotonic saline over 15 min immediately before induction of anesthesia and then 15 mg/kg/h by continuous I.V. infusion until the end of operation.

Sponsors

Fayoum University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Patient will be randomly assigned to one of the two groups. An independent anesthesiologist who will not be participating in the study prepares the study medications.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Age (18-50). * American Society of Anesthesiology (ASA) physical state I or II. * Normal serum electrolytes.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Morphine consumption24 hours after operationin mg

Secondary

MeasureTime frameDescription
Blood serum magnesium concentration12 hours before operationfrom venous blood sample in mg/dl
Incidence of vomiting48 hours after operationas opioid related side effect
Incidence of respiratory depression48 hours after operationas opioid related side effect
Incidence of somnolence48 hours after operationas opioid related side effect
Incidence of oversedation48 hours after operationas opioid related side effect
Incidence of itching48 hours after operationas opioid related side effect
Incidence of constipation48 hours after operationas opioid related side effect
Incidence of paralytic ileus48 hours after operationas opioid related side effect
Mean arterial pressure1 minute before inductionin mm mercury by invasive blood pressure
Heart rate1 minute before inductionin beat per minute by electrocardiogram
Morphine consumption30 minutes after end of surgeryin milligram
Visual Analog Scale30 minutes after end of surgeryPain score which starting from 0:no pain to 10:Worst pain
Assessment of sedation30 minutes after end of surgeryBy 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
Patient satisfaction level48 hours after end of surgeryBy 5-point scale where 1: very unsatisfactory 2:unsatisfactory 3:neutral 4:satisfactory 5:Excellent
Interleukin 6 level in blood24 hours after operationinflammatory mediator measured from venous blood sample
Interleukin 8 level in blood24 hours after operationinflammatory mediator measured from venous blood sample
Tumor necrosis factor alpha level in blood24 hours after operationinflammatory mediator measured from venous blood sample
Incidence of shivering48 hours after operationas opioid related side effect
Incidence of nausea48 hours after operationas opioid related side effect

Other

MeasureTime frameDescription
Weight1 hour before operation once patient is recruitedin kilogram
body mass index1 hour before operation once patient is recruitedkilogram/meter square
Surgery duration1 minute after operationin hours
Anesthesia duration1 minute after withdrawal of all anestheticsin hours from time of induction to withdrawal of all anesthetics
Height1 hour before operation once patient is recruitedin meters
Age1 hour before operation once patient is recruitedin years

Countries

Egypt

Contacts

Primary ContactAhmed A Lotfy, M.Sc.
lotfy_23@yahoo.com1068061357
Backup ContactHany M Yassin, MD
hmy00@fayoum.edu.eg1023912463

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026