the Effect of Intraoperative Magnesium Infusion on Postoperative Cognitive Functions in Adult Patients After Elective Pelvi-abdominal SurgeriesEarly Phase 1NCT04256057
Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function
A Early Phase 1 study testing Magnesium Sulfate in people with the Effect of Intraoperative Magnesium Infusion on Postoperative Cognitive Functions in Adult Patients After Elective Pelvi-abdominal Surgeries, run by Beni-Suef University at 3 sites in Egypt.
Trial summary
The aimof this study is to observe the effect of intraoperative magnesium infusion on peri-operative pain and postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- the Effect of Intraoperative Magnesium Infusion on Postoperative Cognitive Functions in Adult Patients After Elective Pelvi-abdominal Surgeries
- What is being tested?
- Magnesium Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesEgypt
- Study dates
- 15 Mar 2020to 15 Apr 2020
- Phase
- Early Phase 1
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients (age 20-60 years)
- American Society of Anesthesiology(ASA) physical status I-II
- Patients scheduled for elective pelvi-abdominal surgeries
Who cannot join
- Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
- Patients with uncontrolled hypertension or diabetes
- History of hypersensitivity to the drugs to be used
- Control MMSE score ≤23
- Women who are pregnant or breastfeeding
- Patients taking Ca2+ channel blockers, opioids, antidepressants, or antipsychotics or alcohol
Show all 9Show fewer
- Patients having difficulty understanding , vision or hearing problems or CNS disorder as parkinson's disease .
- Morbidly obese patients with a body mass index of >40
- Patients who refused to be involved within the scope of the research.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Recruiting
Beni-Suef University Hospital
Banī Suwayf, 6215
Samaa Rashwan, MD, 0201270159125, samaarashwan1971@gmail.com
fom@med.bsu.edu.eg
- Recruiting
Faculty of Medicine, Beni-SuefUniversity
Giza, 6125
Samaa Rashwan, MD, 0201270159125, samakassemrashwan@gmaail.com
- Recruiting
Faculty of Medicine,Beni-Suef University
Giza, : 62511
Samaa Rashwan, MD, 0201270159125, samaarashwan1971@gmail.com
About this study
Official title: Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function After Pelvi-abdominal Surgeries :an Observational Study
The aimof this study is to observe the effect of intraoperative magnesium infusion on peri-operative pain and postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.
Read the detailed description
This study will be conducted at Beni-Suef University Hospital after approval of the anesthesiology, surgical ICU and pain management department, and the local ethics and research committee, and obtaining written informed consents from the patients .
The inclusion criteria:
- Male and female patients (age 20-60 years)
- American Society of Anesthesiology(ASA) physical status I-II
- Patients scheduled for elective pelvi-abdominal surgeries
The Exclusion criteria
- Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
- Patients with uncontrolled hypertension or diabetes
- History of hypersensitivity to the drugs to be used
- Control MMSE score ≤23
- Women who are pregnant or breastfeeding
- Patients taking Ca2+ channel blockers, opioids, antidepressants, or antipsychotics or alcohol
- Patients having difficulty understanding , vision or hearing problems or CNS disorder as parkinson's disease .
- Morbidly obese patients with a body mass index of >40
- Patients who refused to be involved within the scope of the research. Management of the patients in the operation room All patients will be informed about the tests and written informed consent will be obtained from each of them. The MMSE will be applied. After arrival to the operation theater the monitors will be applied including will be applied including 5 leads ECG, non invasive arterial blood pressure and pulse oximetry. Urinary catheter will be inserted for urine output monitoring. Train of four (TOF) monitoring and Bispectral index (BIS) monitoring will be done in order to evaluate the depth of hypnosis (A-2000 Bispectral Index, Aspect Medical Systems, the Netherlands).
Following 100% oxygen of 5 L/min for 3 min, 1% lidocaine at 0.5 mg/kg will be given intravenously in order to prevent potential injection pain due to propofol and to suppress hemodynamic response to endotracheal intubation. Propofol 2 mg/kg, midazolam 0.03 mg/kg, fentanyl 3μg/kg and 0.6 mg /kg atracurium will be given followed by intubation and Mechanical ventilation with 6 mL/kg tidal volume and a frequency of 8-12/min with total of 4 L/min in 40% O2 air mixture to keep EtCO2 between 36 and 40 mmHg. Anesthesia will be maintained using oxygen and 1-1.5 minimum alveolar concentration (MAC) of isoflurane.
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery .24 In case of a patient with hypotension (mean arterial pressure ˂55 mmHg), 5 mg ephedrine will be injected so that the mean arterial pressure could reach higher than 55 mm Hg. If arrhythmia occured in any of the patients during operation, proper treatment will be be performed and the patient will be excluded from the study. The magnesium sulphate and anaesthetic agent infusions will be discontinued at skin closure. The relaxant effect of magnesium sulfate will be considered so train of four (TOF) monitoring will be used to monitor the muscle relaxation during the surgery and patients will be extubated at the end of the operation based on the TOF > 0.9 to ensure the complete reversal of relaxants by neostigmin.
- Being tested
- Magnesium Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| magnesium sulphate | Other | After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
magnesium infusion on postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
Measured: the observation will be for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Mar 2020 (estimated)
- Primary completion15 Apr 2020 (estimated)
- Study completion15 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Effect of Intraoperative Magnesium Infusion on Postoperative Cognitive Functions in Adult Patients After Elective Pelvi-abdominal SurgeriesStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa Rashwan, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256057
- Sponsor's protocol ID
- faculty of medicine Beni-Suef
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function After Pelvi-abdominal Surgeries :an Observational Study
- ClinicalTrials.gov ID
- NCT04256057
- Acronym / sponsor ID
- faculty of medicine Beni-Suef
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (estimated)
- Primary completion
- 15 Apr 2020 (estimated)
- Study completion
- 15 Apr 2020 (estimated)
- First posted
- 5 Feb 2020 (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 aimof this study is to observe the effect of intraoperative magnesium infusion on peri-operative pain and postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.
Detailed description
This study will be conducted at Beni-Suef University Hospital after approval of the anesthesiology, surgical ICU and pain management department, and the local ethics and research committee, and obtaining written informed consents from the patients .
The inclusion criteria:
- Male and female patients (age 20-60 years)
- American Society of Anesthesiology(ASA) physical status I-II
- Patients scheduled for elective pelvi-abdominal surgeries
The Exclusion criteria
- Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
- Patients with uncontrolled hypertension or diabetes
- History of hypersensitivity to the drugs to be used
- Control MMSE score ≤23
- Women who are pregnant or breastfeeding
- Patients taking Ca2+ channel blockers, opioids, antidepressants, or antipsychotics or alcohol
- Patients having difficulty understanding , vision or hearing problems or CNS disorder as parkinson's disease .
- Morbidly obese patients with a body mass index of >40
- Patients who refused to be involved within the scope of the research. Management of the patients in the operation room All patients will be informed about the tests and written informed consent will be obtained from each of them. The MMSE will be applied. After arrival to the operation theater the monitors will be applied including will be applied including 5 leads ECG, non invasive arterial blood pressure and pulse oximetry. Urinary catheter will be inserted for urine output monitoring. Train of four (TOF) monitoring and Bispectral index (BIS) monitoring will be done in order to evaluate the depth of hypnosis (A-2000 Bispectral Index, Aspect Medical Systems, the Netherlands).
Following 100% oxygen of 5 L/min for 3 min, 1% lidocaine at 0.5 mg/kg will be given intravenously in order to prevent potential injection pain due to propofol and to suppress hemodynamic response to endotracheal intubation. Propofol 2 mg/kg, midazolam 0.03 mg/kg, fentanyl 3μg/kg and 0.6 mg /kg atracurium will be given followed by intubation and Mechanical ventilation with 6 mL/kg tidal volume and a frequency of 8-12/min with total of 4 L/min in 40% O2 air mixture to keep EtCO2 between 36 and 40 mmHg. Anesthesia will be maintained using oxygen and 1-1.5 minimum alveolar concentration (MAC) of isoflurane.
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery .24 In case of a patient with hypotension (mean arterial pressure ˂55 mmHg), 5 mg ephedrine will be injected so that the mean arterial pressure could reach higher than 55 mm Hg. If arrhythmia occured in any of the patients during operation, proper treatment will be be performed and the patient will be excluded from the study. The magnesium sulphate and anaesthetic agent infusions will be discontinued at skin closure. The relaxant effect of magnesium sulfate will be considered so train of four (TOF) monitoring will be used to monitor the muscle relaxation during the surgery and patients will be extubated at the end of the operation based on the TOF > 0.9 to ensure the complete reversal of relaxants by neostigmin.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| magnesium sulphate | Other | Drug: Magnesium SulfateAfter the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female patients (age 20-60 years)
- American Society of Anesthesiology(ASA) physical status I-II
- Patients scheduled for elective pelvi-abdominal surgeries
Key exclusion criteria (9 listed)
- Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
- Patients with uncontrolled hypertension or diabetes
- History of hypersensitivity to the drugs to be used
- Control MMSE score ≤23
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| Magnesium SulfateAfter the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery | Drug | magnesium sulphate |
Primary outcome
magnesium infusion on postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.
Time frame: the observation will be for 24 hours
After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Magnesium Sulfate in people with the Effect of Intraoperative Magnesium Infusion on Postoperative Cognitive Functions in Adult Patients After Elective Pelvi-abdominal Surgeries, run by Beni-Suef University at 3 sites 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 9 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
magnesium infusion on postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries. (time frame: the observation will be for 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.