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.
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.
Egypt1 site, 1 recruiting
- 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
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.
- Conditions
- Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| S group | Placebo comparator | Isotonic saline as placebo will be given. Receives: Drug: isotonic saline |
| M group | Active comparator | Magnesium 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.
Postoperative Morphine consumption
in mg
Measured: 24 hours after operation
Secondary outcomes (49)
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 1 minute before induction
Heart rate
in beat per minute by electrocardiogram
Measured: 1 minute before induction
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 30 seconds before intubation
Heart rate
in beat per minute by electrocardiogram
Measured: 30 seconds before intubation
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 5 minutes after beginning of surgery
Heart rate
in beat per minute by electrocardiogram
Measured: 5 minutes after beginning of surgery
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 15 minutes after beginning of surgery
Heart rate
in beat per minute by electrocardiogram
Measured: 15 minutes after beginning of surgery
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 30 minutes after beginning of surgery
Heart rate
in beat per minute by electrocardiogram
Measured: 30 minutes after beginning of surgery
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 60 minutes after beginning of surgery
Heart rate
in beat per minute by electrocardiogram
Measured: 60 minutes after beginning of surgery
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 120 minutes after beginning of surgery
Heart rate
in beat per minute by electrocardiogram
Measured: 120 minutes after beginning of surgery
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 30 minutes after end of surgery
Heart rate
in beat per minute by electrocardiogram
Measured: 30 minutes after end of surgery
Morphine consumption
in milligram
Measured: 30 minutes after end of surgery
Visual Analog Scale
Pain score which starting from 0:no pain to 10:Worst pain
Measured: 30 minutes after end of surgery
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
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 4 hours after end of surgery
Heart rate
in beat per minute by electrocardiogram
Measured: 4 hours after end of surgery
Morphine consumption
in milligram
Measured: 4 hours after end of surgery
Visual Analog Scale
Pain score which starting from 0:no pain to 10:Worst pain
Measured: 4 hours after end of surgery
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
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 24 hours after end of surgery
Heart rate
in beat per minute by electrocardiogram
Measured: 24 hours after end of surgery
Morphine consumption
in milligram
Measured: 24 hours after end of surgery
Visual Analog Scale
Pain score which starting from 0:no pain to 10:Worst pain
Measured: 24 hours after end of surgery
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
Mean arterial pressure
in mm mercury by invasive blood pressure
Measured: 48 hours after end of surgery
Heart rate
in beat per minute by electrocardiogram
Measured: 48 hours after end of surgery
Morphine consumption
in milligram
Measured: 48 hours after end of surgery
Visual Analog Scale
Pain score which starting from 0:no pain to 10:Worst pain
Measured: 48 hours after end of surgery
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
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
Blood serum magnesium concentration
from venous blood sample in mg/dl
Measured: 12 hours before operation
Blood serum magnesium concentration
from venous blood sample in mg/dl
Measured: 15 minutes after operation
Interleukin 6 level in blood
inflammatory mediator measured from venous blood sample
Measured: 24 hours after operation
Interleukin 8 level in blood
inflammatory mediator measured from venous blood sample
Measured: 24 hours after operation
Tumor necrosis factor alpha level in blood
inflammatory mediator measured from venous blood sample
Measured: 24 hours after operation
Incidence of shivering
as opioid related side effect
Measured: 48 hours after operation
Incidence of nausea
as opioid related side effect
Measured: 48 hours after operation
Incidence of vomiting
as opioid related side effect
Measured: 48 hours after operation
Incidence of respiratory depression
as opioid related side effect
Measured: 48 hours after operation
Incidence of somnolence
as opioid related side effect
Measured: 48 hours after operation
Incidence of oversedation
as opioid related side effect
Measured: 48 hours after operation
Incidence of itching
as opioid related side effect
Measured: 48 hours after operation
Incidence of constipation
as opioid related side effect
Measured: 48 hours after operation
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.
- First posted24 Oct 2018
- Study start8 May 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany M Yassin, MD, Fayoum University Hospital
- Investigators
- Mostafa S Elhamamsy, MD, Study chair, Faculty of medicine, Fayoum UniversityAhmed M Yassin, MD, Study director, Faculty of medicine, Beni-suef UniversityAbeer S Goda, MD, Study director, Faculty of medicine, Fayoum UniversityHany M Yassin, MD, Principal investigator, Faculty of medicine, Fayoum University
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 27788811Demiroglu 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 27022607Sousa 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 27687417Yassin 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 28856110Karbasy 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Intraoperative Magnesium Sulfate Administration on Postoperative Morphine Requirement in Living Donor During Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT03717467
- Acronym / sponsor ID
- D129
- Conditions
- Postoperative Pain
- Keywords
- Magnesium sulfate, Morphine requirement, Hepatotomy, Orthotopic liver transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S group | Placebo comparator | Drug: isotonic salineIsotonic saline as placebo will be given. |
| M group | Active comparator | Drug: Magnesium SulfateMagnesium sulfate will be given |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age (18-50).
- American Society of Anesthesiology (ASA) physical state I or II.
- Normal serum electrolytes.
Key exclusion criteria (10 listed)
- Impaired hepatic or renal functions.
- Various degree of heart block.
- Hypertension
- Diabetes
- Myopathy or any neurological disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isotonic salineAlso: Saline group100 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. | Drug | S group |
| Magnesium SulfateAlso: Magnesium group40 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. | Drug | M group |
Primary outcome
Postoperative Morphine consumption
Time frame: 24 hours after operation
in mg
49 secondary outcomes
Mean arterial pressure
Time frame: 1 minute before induction
Heart rate
Time frame: 1 minute before induction
Mean arterial pressure
Time frame: 30 seconds before intubation
Heart rate
Time frame: 30 seconds before intubation
Mean arterial pressure
Time frame: 5 minutes after beginning of surgery
Heart rate
Time frame: 5 minutes after beginning of surgery
Mean arterial pressure
Time frame: 15 minutes after beginning of surgery
Heart rate
Time frame: 15 minutes after beginning of surgery
Mean arterial pressure
Time frame: 30 minutes after beginning of surgery
Heart rate
Time frame: 30 minutes after beginning of surgery
Mean arterial pressure
Time frame: 60 minutes after beginning of surgery
Heart rate
Time frame: 60 minutes after beginning of surgery
Mean arterial pressure
Time frame: 120 minutes after beginning of surgery
Heart rate
Time frame: 120 minutes after beginning of surgery
Mean arterial pressure
Time frame: 30 minutes after end of surgery
Heart rate
Time frame: 30 minutes after end of surgery
Morphine consumption
Time frame: 30 minutes after end of surgery
Visual Analog Scale
Time frame: 30 minutes after end of surgery
Assessment of sedation
Time frame: 30 minutes after end of surgery
Mean arterial pressure
Time frame: 4 hours after end of surgery
Heart rate
Time frame: 4 hours after end of surgery
Morphine consumption
Time frame: 4 hours after end of surgery
Visual Analog Scale
Time frame: 4 hours after end of surgery
Assessment of sedation
Time frame: 4 hours after end of surgery
Mean arterial pressure
Time frame: 24 hours after end of surgery
Heart rate
Time frame: 24 hours after end of surgery
Morphine consumption
Time frame: 24 hours after end of surgery
Visual Analog Scale
Time frame: 24 hours after end of surgery
Assessment of sedation
Time frame: 24 hours after end of surgery
Mean arterial pressure
Time frame: 48 hours after end of surgery
Heart rate
Time frame: 48 hours after end of surgery
Morphine consumption
Time frame: 48 hours after end of surgery
Visual Analog Scale
Time frame: 48 hours after end of surgery
Assessment of sedation
Time frame: 48 hours after end of surgery
Patient satisfaction level
Time frame: 48 hours after end of surgery
Blood serum magnesium concentration
Time frame: 12 hours before operation
Blood serum magnesium concentration
Time frame: 15 minutes after operation
Interleukin 6 level in blood
Time frame: 24 hours after operation
Interleukin 8 level in blood
Time frame: 24 hours after operation
Tumor necrosis factor alpha level in blood
Time frame: 24 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Background: PubMed 27788811Gucyetmez 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.
- Background: PubMed 27022607Demiroglu 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.
- Background: PubMed 27687417Sousa 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.
- Background: PubMed 28856110Yassin 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.
- Background: PubMed 25798378Karbasy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa S Elhamamsy, MD study chair
Faculty of medicine, Fayoum University
Ahmed M Yassin, MD study director
Faculty of medicine, Beni-suef University
Abeer S Goda, MD study director
Faculty of medicine, Fayoum University
1 site in 1 country: see every site and its status.
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.