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Intraoperative Magnesium Sulfate Administration During Orthotopic Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717467
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hany M Yassin, MD, 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: isotonic saline Drug: Magnesium Sulfate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Prevention
Official Title: The Influence of Intraoperative Magnesium Sulfate Administration on Postoperative Morphine Requirement in Living Donor During Orthotopic Liver Transplantation
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: S group
Isotonic saline as placebo will be given.
Drug: isotonic 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.
Other Name: Saline group

Active Comparator: M group
Magnesium sulfate will be given
Drug: Magnesium 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.
Other Name: Magnesium group




Primary Outcome Measures :
  1. Postoperative Morphine consumption [ Time Frame: 24 hours after operation ]
    in mg


Secondary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: 1 minute before induction ]
    in mm mercury by invasive blood pressure

  2. Heart rate [ Time Frame: 1 minute before induction ]
    in beat per minute by electrocardiogram

  3. Mean arterial pressure [ Time Frame: 30 seconds before intubation ]
    in mm mercury by invasive blood pressure

  4. Heart rate [ Time Frame: 30 seconds before intubation ]
    in beat per minute by electrocardiogram

  5. Mean arterial pressure [ Time Frame: 5 minutes after beginning of surgery ]
    in mm mercury by invasive blood pressure

  6. Heart rate [ Time Frame: 5 minutes after beginning of surgery ]
    in beat per minute by electrocardiogram

  7. Mean arterial pressure [ Time Frame: 15 minutes after beginning of surgery ]
    in mm mercury by invasive blood pressure

  8. Heart rate [ Time Frame: 15 minutes after beginning of surgery ]
    in beat per minute by electrocardiogram

  9. Mean arterial pressure [ Time Frame: 30 minutes after beginning of surgery ]
    in mm mercury by invasive blood pressure

  10. Heart rate [ Time Frame: 30 minutes after beginning of surgery ]
    in beat per minute by electrocardiogram

  11. Mean arterial pressure [ Time Frame: 60 minutes after beginning of surgery ]
    in mm mercury by invasive blood pressure

  12. Heart rate [ Time Frame: 60 minutes after beginning of surgery ]
    in beat per minute by electrocardiogram

  13. Mean arterial pressure [ Time Frame: 120 minutes after beginning of surgery ]
    in mm mercury by invasive blood pressure

  14. Heart rate [ Time Frame: 120 minutes after beginning of surgery ]
    in beat per minute by electrocardiogram

  15. Mean arterial pressure [ Time Frame: 30 minutes after end of surgery ]
    in mm mercury by invasive blood pressure

  16. Heart rate [ Time Frame: 30 minutes after end of surgery ]
    in beat per minute by electrocardiogram

  17. Morphine consumption [ Time Frame: 30 minutes after end of surgery ]
    in milligram

  18. Visual Analog Scale [ Time Frame: 30 minutes after end of surgery ]
    Pain score which starting from 0:no pain to 10:Worst pain

  19. Assessment of sedation [ Time Frame: 30 minutes 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

  20. Mean arterial pressure [ Time Frame: 4 hours after end of surgery ]
    in mm mercury by invasive blood pressure

  21. Heart rate [ Time Frame: 4 hours after end of surgery ]
    in beat per minute by electrocardiogram

  22. Morphine consumption [ Time Frame: 4 hours after end of surgery ]
    in milligram

  23. Visual Analog Scale [ Time Frame: 4 hours after end of surgery ]
    Pain score which starting from 0:no pain to 10:Worst pain

  24. Assessment of sedation [ Time Frame: 4 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

  25. Mean arterial pressure [ Time Frame: 24 hours after end of surgery ]
    in mm mercury by invasive blood pressure

  26. Heart rate [ Time Frame: 24 hours after end of surgery ]
    in beat per minute by electrocardiogram

  27. Morphine consumption [ Time Frame: 24 hours after end of surgery ]
    in milligram

  28. Visual Analog Scale [ Time Frame: 24 hours after end of surgery ]
    Pain score which starting from 0:no pain to 10:Worst pain

  29. Assessment of sedation [ Time Frame: 24 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

  30. Mean arterial pressure [ Time Frame: 48 hours after end of surgery ]
    in mm mercury by invasive blood pressure

  31. Heart rate [ Time Frame: 48 hours after end of surgery ]
    in beat per minute by electrocardiogram

  32. Morphine consumption [ Time Frame: 48 hours after end of surgery ]
    in milligram

  33. Visual Analog Scale [ Time Frame: 48 hours after end of surgery ]
    Pain score which starting from 0:no pain to 10:Worst pain

  34. Assessment of sedation [ Time Frame: 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

  35. Patient satisfaction level [ Time Frame: 48 hours after end of surgery ]
    By 5-point scale where 1: very unsatisfactory 2:unsatisfactory 3:neutral 4:satisfactory 5:Excellent

  36. Blood serum magnesium concentration [ Time Frame: 12 hours before operation ]
    from venous blood sample in mg/dl

  37. Blood serum magnesium concentration [ Time Frame: 15 minutes after operation ]
    from venous blood sample in mg/dl

  38. Interleukin 6 level in blood [ Time Frame: 24 hours after operation ]
    inflammatory mediator measured from venous blood sample

  39. Interleukin 8 level in blood [ Time Frame: 24 hours after operation ]
    inflammatory mediator measured from venous blood sample

  40. Tumor necrosis factor alpha level in blood [ Time Frame: 24 hours after operation ]
    inflammatory mediator measured from venous blood sample

  41. Incidence of shivering [ Time Frame: 48 hours after operation ]
    as opioid related side effect

  42. Incidence of nausea [ Time Frame: 48 hours after operation ]
    as opioid related side effect

  43. Incidence of vomiting [ Time Frame: 48 hours after operation ]
    as opioid related side effect

  44. Incidence of respiratory depression [ Time Frame: 48 hours after operation ]
    as opioid related side effect

  45. Incidence of somnolence [ Time Frame: 48 hours after operation ]
    as opioid related side effect

  46. Incidence of oversedation [ Time Frame: 48 hours after operation ]
    as opioid related side effect

  47. Incidence of itching [ Time Frame: 48 hours after operation ]
    as opioid related side effect

  48. Incidence of constipation [ Time Frame: 48 hours after operation ]
    as opioid related side effect

  49. Incidence of paralytic ileus [ Time Frame: 48 hours after operation ]
    as opioid related side effect


Other Outcome Measures:
  1. Age [ Time Frame: 1 hour before operation once patient is recruited ]
    in years

  2. Height [ Time Frame: 1 hour before operation once patient is recruited ]
    in meters

  3. Weight [ Time Frame: 1 hour before operation once patient is recruited ]
    in kilogram

  4. body mass index [ Time Frame: 1 hour before operation once patient is recruited ]
    kilogram/meter square

  5. Surgery duration [ Time Frame: 1 minute after operation ]
    in hours

  6. Anesthesia duration [ Time Frame: 1 minute after withdrawal of all anesthetics ]
    in hours from time of induction to withdrawal of all anesthetics



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717467


Contacts
Layout table for location contacts
Contact: Ahmed A Lotfy, M.Sc. 1068061357 ext +20 lotfy_23@yahoo.com
Contact: Hany M Yassin, MD 1023912463 ext +20 hmy00@fayoum.edu.eg

Locations
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Egypt
Sheikh Zayed hospital Recruiting
Giza, Egypt, 12573
Contact: Hany M Yassin, MD    1111363602 ext +20    hmy00@fayoum.edu.eg   
Contact: Yasser S Mostafa, MD    1010509735 ext +20    ysm03@fayoum.edu.eg   
Sponsors and Collaborators
Fayoum University Hospital
Investigators
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Study Chair: Mostafa S Elhamamsy, MD Faculty of medicine, Fayoum University
Study Director: Ahmed M Yassin, MD Faculty of medicine, Beni-suef University
Study Director: Abeer S Goda, MD Faculty of medicine, Fayoum University
Principal Investigator: Hany M Yassin, MD Faculty of medicine, Fayoum University

Publications:

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Responsible Party: Hany M Yassin, MD, Associate professor of anesthesia, Fayoum University Hospital
ClinicalTrials.gov Identifier: NCT03717467    
Other Study ID Numbers: D129
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hany M Yassin, MD, Fayoum University Hospital:
Magnesium sulfate
Morphine requirement
Hepatotomy
Orthotopic liver transplantation
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Magnesium Sulfate
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents