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Postoperative PainNCT03717467

Intraoperative Magnesium Sulfate Administration During Orthotopic Liver Transplantation

A study testing isotonic saline and Magnesium Sulfate in people with Postoperative Pain, run by Fayoum University Hospital at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
isotonic saline and Magnesium Sulfate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
8 May 2019to 1 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Impaired hepatic or renal functions.
  • Various degree of heart block.
  • Hypertension
  • Diabetes
  • Myopathy or any neurological disorder.
  • History of long term opioid use
Show all 10Show fewer
  • Patients treated with calcium channel blockers
  • Patients with known allergy to drug used.
  • Pregnant woman
  • Obesity (Body Mass Index > 30).

Trial locations and contacts

1 site in 1 country.

Ahmed A Lotfy, M.Sc. contact

1068061357 ext. +20

lotfy_23@yahoo.com

Egypt1 site, 1 recruiting
  • Sheikh Zayed hospital

    Giza, 12573

    Hany M Yassin, MD, 1111363602 ext. +20, hmy00@fayoum.edu.eg

    Yasser S Mostafa, MD, 1010509735 ext. +20, ysm03@fayoum.edu.eg

    Recruiting

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
isotonic saline, Magnesium Sulfate
Keywords
Magnesium sulfate, Morphine requirement, Hepatotomy, Orthotopic liver transplantation
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • isotonic salineDrug

    Also called Saline group

    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.

  • Magnesium SulfateDrug

    Also called Magnesium group

    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.

Study groups in NCT03717467
Study groupRoleWhat they receive
S groupPlacebo comparatorIsotonic saline as placebo will be given.
Receives: Drug: isotonic saline
M groupActive comparatorMagnesium sulfate will be given
Receives: Drug: Magnesium Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Morphine consumption

    in mg

    Measured: 24 hours after operation

Secondary outcomes (49)
  1. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 1 minute before induction

  2. Heart rate

    in beat per minute by electrocardiogram

    Measured: 1 minute before induction

  3. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 30 seconds before intubation

  4. Heart rate

    in beat per minute by electrocardiogram

    Measured: 30 seconds before intubation

  5. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 5 minutes after beginning of surgery

  6. Heart rate

    in beat per minute by electrocardiogram

    Measured: 5 minutes after beginning of surgery

  7. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 15 minutes after beginning of surgery

  8. Heart rate

    in beat per minute by electrocardiogram

    Measured: 15 minutes after beginning of surgery

  9. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 30 minutes after beginning of surgery

  10. Heart rate

    in beat per minute by electrocardiogram

    Measured: 30 minutes after beginning of surgery

  11. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 60 minutes after beginning of surgery

  12. Heart rate

    in beat per minute by electrocardiogram

    Measured: 60 minutes after beginning of surgery

  13. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 120 minutes after beginning of surgery

  14. Heart rate

    in beat per minute by electrocardiogram

    Measured: 120 minutes after beginning of surgery

  15. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 30 minutes after end of surgery

  16. Heart rate

    in beat per minute by electrocardiogram

    Measured: 30 minutes after end of surgery

  17. Morphine consumption

    in milligram

    Measured: 30 minutes after end of surgery

  18. Visual Analog Scale

    Pain score which starting from 0:no pain to 10:Worst pain

    Measured: 30 minutes after end of surgery

  19. Assessment of sedation

    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

    Measured: 30 minutes after end of surgery

  20. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 4 hours after end of surgery

  21. Heart rate

    in beat per minute by electrocardiogram

    Measured: 4 hours after end of surgery

  22. Morphine consumption

    in milligram

    Measured: 4 hours after end of surgery

  23. Visual Analog Scale

    Pain score which starting from 0:no pain to 10:Worst pain

    Measured: 4 hours after end of surgery

  24. Assessment of sedation

    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

    Measured: 4 hours after end of surgery

  25. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 24 hours after end of surgery

  26. Heart rate

    in beat per minute by electrocardiogram

    Measured: 24 hours after end of surgery

  27. Morphine consumption

    in milligram

    Measured: 24 hours after end of surgery

  28. Visual Analog Scale

    Pain score which starting from 0:no pain to 10:Worst pain

    Measured: 24 hours after end of surgery

  29. Assessment of sedation

    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

    Measured: 24 hours after end of surgery

  30. Mean arterial pressure

    in mm mercury by invasive blood pressure

    Measured: 48 hours after end of surgery

  31. Heart rate

    in beat per minute by electrocardiogram

    Measured: 48 hours after end of surgery

  32. Morphine consumption

    in milligram

    Measured: 48 hours after end of surgery

  33. Visual Analog Scale

    Pain score which starting from 0:no pain to 10:Worst pain

    Measured: 48 hours after end of surgery

  34. Assessment of sedation

    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

    Measured: 48 hours after end of surgery

  35. Patient satisfaction level

    By 5-point scale where 1: very unsatisfactory 2:unsatisfactory 3:neutral 4:satisfactory 5:Excellent

    Measured: 48 hours after end of surgery

  36. Blood serum magnesium concentration

    from venous blood sample in mg/dl

    Measured: 12 hours before operation

  37. Blood serum magnesium concentration

    from venous blood sample in mg/dl

    Measured: 15 minutes after operation

  38. Interleukin 6 level in blood

    inflammatory mediator measured from venous blood sample

    Measured: 24 hours after operation

  39. Interleukin 8 level in blood

    inflammatory mediator measured from venous blood sample

    Measured: 24 hours after operation

  40. Tumor necrosis factor alpha level in blood

    inflammatory mediator measured from venous blood sample

    Measured: 24 hours after operation

  41. Incidence of shivering

    as opioid related side effect

    Measured: 48 hours after operation

  42. Incidence of nausea

    as opioid related side effect

    Measured: 48 hours after operation

  43. Incidence of vomiting

    as opioid related side effect

    Measured: 48 hours after operation

  44. Incidence of respiratory depression

    as opioid related side effect

    Measured: 48 hours after operation

  45. Incidence of somnolence

    as opioid related side effect

    Measured: 48 hours after operation

  46. Incidence of oversedation

    as opioid related side effect

    Measured: 48 hours after operation

  47. Incidence of itching

    as opioid related side effect

    Measured: 48 hours after operation

  48. Incidence of constipation

    as opioid related side effect

    Measured: 48 hours after operation

  49. Incidence of paralytic ileus

    as opioid related side effect

    Measured: 48 hours after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2018
  2. Study start8 May 2019
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03717467
Sponsor's protocol ID
D129
Status last verified
Nov 2020
First submitted
22 Oct 2018
Last updated
9 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gucyetmez B, Atalan HK, Aslan S, Yazar S, Polat KY. Effects of Intraoperative Magnesium Sulfate Administration on Postoperative Tramadol Requirement in Liver Transplantation: A Prospective, Double-Blind Study. Transplant Proc. 2016 Oct;48(8):2742-2746. doi: 10.1016/j.transproceed.2016.08.033.

    PubMed 27788811
  • Demiroglu M, Un C, Ornek DH, Kici O, Yildirim AE, Horasanli E, Baskan S, Fikir E, Gamli M, Dikmen B. The Effect of Systemic and Regional Use of Magnesium Sulfate on Postoperative Tramadol Consumption in Lumbar Disc Surgery. Biomed Res Int. 2016;2016:3216246. doi: 10.1155/2016/3216246. Epub 2016 Jan 28.

    PubMed 27022607
  • Sousa AM, Rosado GM, Neto Jde S, Guimaraes GM, Ashmawi HA. Magnesium sulfate improves postoperative analgesia in laparoscopic gynecologic surgeries: a double-blind randomized controlled trial. J Clin Anesth. 2016 Nov;34:379-84. doi: 10.1016/j.jclinane.2016.05.006. Epub 2016 Jun 5.

    PubMed 27687417
  • Yassin HM, Abd Elmoneim AT, El Moutaz H. The Analgesic Efficiency of Ultrasound-Guided Rectus Sheath Analgesia Compared with Low Thoracic Epidural Analgesia After Elective Abdominal Surgery with a Midline Incision: A Prospective Randomized Controlled Trial. Anesth Pain Med. 2017 Jun 10;7(3):e14244. doi: 10.5812/aapm.14244. eCollection 2017 Jun.

    PubMed 28856110
  • Karbasy SH, Derakhshan P. Effects of opium addiction on level of sensory block in spinal anesthesia with bupivacaine for lower abdomen and limb surgery: a case-control study. Anesth Pain Med. 2014 Nov 26;4(5):e21571. doi: 10.5812/aapm.21571. eCollection 2014 Dec.

    PubMed 25798378

Questions about this trial

What is this clinical trial studying?

A study testing isotonic saline and Magnesium Sulfate in people with Postoperative Pain, run by Fayoum University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmed A Lotfy, M.Sc. (1068061357 ext. +20, lotfy_23@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Morphine consumption (time frame: 24 hours after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03717467, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.

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