MagnesiumPhase 2/3NCT06131905

Magnesium Sulfate as an Adjuvant to Propofol During Consious Sedation in Colonoscopy

A Phase 2/3 study testing Magnesium Sulfate and Propofol in people with Magnesium and Intraoperative Analgesia, run by Assiut University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Search all trials

Trial summary

Colonoscopy is one of the most commonly performed outpatient procedures throughout the world as a screening, diagnostic, and therapeutic tool to evaluate the large intestine from the distal rectum to the cecum.Propofol is the most commonly used hypnotic agent in sedation during endoscopic procedures for its advantages… Read more about this study

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Magnesium, Intraoperative Analgesia
What is being tested?: Magnesium Sulfate and Propofol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: 1 Jan 2024to 1 Dec 2025
Phase: Phase 2/3
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 40 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. The subject is scheduled for elective colonoscopy. 2. The subject is ≥ 40 years and ≤ 70 years. 3. Both sexes. 4.No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests. 5. ASA class 1-3.

Who cannot join

1.Subject is known or believed to be pregnant or lactating women. 2. Patients are known hypersensitivity to any of the drugs that would be used in the study. 3. Severe cardiac, renal, lung, or liver diseases. 4. Hypotension (systolic blood pressure< 90 mm Hg), uncontrolled hypertension (systolic blood pressure> 170 mmHg, diastolic blood pressure> 100mmHg). 5. Chronic Opioid Use (daily or almost daily use of opioids for> 3 months). 6. Patients that are immunologically compromised. 7. Sleep apnea syndrome or difficult airway. 8. preexisting hypoxemia (Spo2< 90 %). 9. History of adverse events with prior sedation. Additionally, patients who had taken any sedative drugs within the previous 24h

Trial locations and contacts

No sites are listed yet.

Mohamed Sayed Mahmoud Sayed, Master contact

01091383026 ext. 01122856977

ms0109138@gmail.com

About this study

Official title: Magnesium Sulfate as an Adjuvant to Propofol During Consious Sedation in Adult Patients Undergoing Colonoscopy

Colonoscopy is one of the most commonly performed outpatient procedures throughout the world as a screening, diagnostic, and therapeutic tool to evaluate the large intestine from the distal rectum to the cecum.Propofol is the most commonly used hypnotic agent in sedation during endoscopic procedures for its advantages of fast onset and quick recovery. However, propofol may cause respiratory depression and cardiovascular events, which are easier to appear in cases of old age and high speed administration of propofol.Magnesium is a non-specific calcium channel inhibitor and a non-competitive N-methyl-D-aspartate(NMDA)receptor antagonist, which has analgesic and mild sedative properties .

Read the detailed description

Colonoscopy is one of the most commonly performed outpatient procedures throughout the world as a screening, diagnostic, and therapeutic tool to evaluate the large intestine from the distal rectum to the cecum . Colonoscopy is currently an important examination method for colorectal diseases. It can provide clear images of lesions and provide biopsy for biopsy. It can improve the accuracy and sensitivity of colorectal cancer diagnosis .The most common complications in gastrointestinal endoscopy are not related to the procedure, but they are related to sedation; they include cardio- respiratory adverse events such as hypoxemia, hypoventilation, apnea, dysrhythmias, hypotension and vasovagal episodes .Propofol is the most commonly used hypnotic agent in sedation during endoscopic procedures for its advantages of fast onset and quick recovery. However, propofol may cause respiratory depression and cardiovascular events, which are easier to appear in cases of old age and high speed administration of propofol . Moreover, high doses of propofol may cause dose-dependent hemodynamic instability in older or feeble patients. Therefore, it is essential to minimize the dosage of propofol to prevent cardiopulmonary complications associated with sedation, especially in the elderly, by combining with an adjuvant medication. Although benzodiazepines or opioids combined with propofol can reduce the consumption of propofol, elderly patients usually feature a higher overall body fat content than younger patients which may delay the metabolism of lipid-soluble propofol, opioid, and benzodiazepines . Magnesium is the fourth most plentiful cation in the body and the second most plentiful intracellular cation after potassium. Approximately one half of total body magnesium is present in bone and 20% in skeletal muscle. Magnesium is necessary for the presynaptic release of acetylcholine from nerve endings and may produce effects similar to calcium-entry-blocking drugs . Magnesium is a non-specific calcium channel inhibitor and a non-competitive N-methyl-D-aspartate(NMDA)receptor antagonist, which has analgesic and mild sedative properties . It has been demonstrated that intravenous administration of magnesium sulfate can reduce the overall use of intraoperative propofol and the postoperative analgesia requirement effectively in various types of surgery .These findings implied that magnesium sulfate may be used as a promising adjuvant drug for colonoscopy sedation due to its analgesic and sedative properties .

Conditions: Magnesium, Intraoperative Analgesia
Being tested: Magnesium Sulfate, Propofol

What participants receive

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

Magnesium SulfateDrug
40 mg/kg magnesium sulfate diluted with normal saline to a total volume of 100 ml was administered for 15 min.plus ,An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h
PropofolDrug
An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h

Study groups in NCT06131905
Study group	Role	What they receive
Group M (Magnesium sulfate+Propofol)	Active comparator	Includes thirdy patients receive 40mg /kg magnesium sulfate diluted with normal saline to a total volume of 100 ml plus ,An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h Receives: Drug: Magnesium Sulfate; Drug: Propofol
Group N (Propofol)	Active comparator	Includes thirdy patients receive an equal volume of normal saline as a placebo.plus An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h Receives: Drug: Propofol

What is being measured

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

Total consumption of propfol
Calculate the total dose of propofol used for each case
Measured: During procedure

Secondary outcomes (1)

sedation time
Measure sedation time during and after procedure
Measured: During procedure and One hour after procedure

Timeline

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

1 Jan 20241 Dec 2025

First posted14 Nov 2023
Study start1 Jan 2024 (estimated)
Primary completion1 Jan 2025 (estimated)
Study completion1 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for MagnesiumStudies of the same condition, open and under way.
More trials run by Assiut 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: Phase 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06131905
Sponsor's protocol ID: Magnesium in colonoscopy
Status last verified: Dec 2023
First submitted: 2 Nov 2023
Last updated: 18 Dec 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Liu J, Liu X, Peng LP, Ji R, Liu C, Li YQ. Efficacy and safety of intravenous lidocaine in propofol-based sedation for ERCP procedures: a prospective, randomized, double-blinded, controlled trial. Gastrointest Endosc. 2020 Aug;92(2):293-300. doi: 10.1016/j.gie.2020.02.050. Epub 2020 Mar 7.
PubMed 32156544
Lu Z, Li W, Chen H, Qian Y. Efficacy of a Dexmedetomidine-Remifentanil Combination Compared with a Midazolam-Remifentanil Combination for Conscious Sedation During Therapeutic Endoscopic Retrograde Cholangio-Pancreatography: A Prospective, Randomized, Single-Blinded Preliminary Trial. Dig Dis Sci. 2018 Jun;63(6):1633-1640. doi: 10.1007/s10620-018-5034-3. Epub 2018 Mar 29.
PubMed 29594976
Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.
PubMed 21364460
Olgun B, Oguz G, Kaya M, Savli S, Eskicirak HE, Guney I, Kadiogullari N. The effects of magnesium sulphate on desflurane requirement, early recovery and postoperative analgesia in laparascopic cholecystectomy. Magnes Res. 2012 Jul;25(2):72-8. doi: 10.1684/mrh.2012.0315.
PubMed 22728648
De Oliveira GS, Bialek J, Fitzgerald P, Kim JY, McCarthy RJ. Systemic magnesium to improve quality of post-surgical recovery in outpatient segmental mastectomy: a randomized, double-blind, placebo-controlled trial. Magnes Res. 2013 Oct-Dec;26(4):156-64. doi: 10.1684/mrh.2014.0349.
PubMed 24491463
Rex DK, Khalfan HK. Sedation and the technical performance of colonoscopy. Gastrointest Endosc Clin N Am. 2005 Oct;15(4):661-72. doi: 10.1016/j.giec.2005.08.003.
PubMed 16278131
Wernli KJ, Brenner AT, Rutter CM, Inadomi JM. Risks Associated With Anesthesia Services During Colonoscopy. Gastroenterology. 2016 Apr;150(4):888-94; quiz e18. doi: 10.1053/j.gastro.2015.12.018. Epub 2015 Dec 18.
PubMed 26709032
Cote GA, Hovis RM, Ansstas MA, Waldbaum L, Azar RR, Early DS, Edmundowicz SA, Mullady DK, Jonnalagadda SS. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010 Feb;8(2):137-42. doi: 10.1016/j.cgh.2009.07.008. Epub 2009 Jul 14.
PubMed 19607937

Want to know more?

Mohamed Sayed Mahmoud Sayed, Master

01091383026 ext. 01122856977

ms0109138@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Magnesium trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Magnesium Sulfate as an Adjuvant to Propofol During Consious Sedation in Adult Patients Undergoing Colonoscopy
ClinicalTrials.gov ID: NCT06131905
Acronym / sponsor ID: Magnesium in colonoscopy
Conditions: Magnesium, Intraoperative Analgesia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 1 Jan 2024 (estimated)
Primary completion: 1 Jan 2025 (estimated)
Study completion: 1 Dec 2025 (estimated)
First posted: 14 Nov 2023 (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.

Colonoscopy is one of the most commonly performed outpatient procedures throughout the world as a screening, diagnostic, and therapeutic tool to evaluate the large intestine from the distal rectum to the cecum.Propofol is the most commonly used hypnotic agent in sedation during endoscopic procedures for its advantages of fast onset and quick recovery. However, propofol may cause respiratory depression and cardiovascular events, which are easier to appear in cases of old age and high speed administration of propofol.Magnesium is a non-specific calcium channel inhibitor and a non-competitive N-methyl-D-aspartate(NMDA)receptor antagonist, which has analgesic and mild sedative properties .

Detailed description

Colonoscopy is one of the most commonly performed outpatient procedures throughout the world as a screening, diagnostic, and therapeutic tool to evaluate the large intestine from the distal rectum to the cecum . Colonoscopy is currently an important examination method for colorectal diseases. It can provide clear images of lesions and provide biopsy for biopsy. It can improve the accuracy and sensitivity of colorectal cancer diagnosis .The most common complications in gastrointestinal endoscopy are not related to the procedure, but they are related to sedation; they include cardio- respiratory adverse events such as hypoxemia, hypoventilation, apnea, dysrhythmias, hypotension and vasovagal episodes .Propofol is the most commonly used hypnotic agent in sedation during endoscopic procedures for its advantages of fast onset and quick recovery. However, propofol may cause respiratory depression and cardiovascular events, which are easier to appear in cases of old age and high speed administration of propofol . Moreover, high doses of propofol may cause dose-dependent hemodynamic instability in older or feeble patients. Therefore, it is essential to minimize the dosage of propofol to prevent cardiopulmonary complications associated with sedation, especially in the elderly, by combining with an adjuvant medication. Although benzodiazepines or opioids combined with propofol can reduce the consumption of propofol, elderly patients usually feature a higher overall body fat content than younger patients which may delay the metabolism of lipid-soluble propofol, opioid, and benzodiazepines . Magnesium is the fourth most plentiful cation in the body and the second most plentiful intracellular cation after potassium. Approximately one half of total body magnesium is present in bone and 20% in skeletal muscle. Magnesium is necessary for the presynaptic release of acetylcholine from nerve endings and may produce effects similar to calcium-entry-blocking drugs . Magnesium is a non-specific calcium channel inhibitor and a non-competitive N-methyl-D-aspartate(NMDA)receptor antagonist, which has analgesic and mild sedative properties . It has been demonstrated that intravenous administration of magnesium sulfate can reduce the overall use of intraoperative propofol and the postoperative analgesia requirement effectively in various types of surgery .These findings implied that magnesium sulfate may be used as a promising adjuvant drug for colonoscopy sedation due to its analgesic and sedative properties .

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Group M (Magnesium sulfate+Propofol)	Active comparator	Drug: Magnesium Sulfate, Drug: PropofolIncludes thirdy patients receive 40mg /kg magnesium sulfate diluted with normal saline to a total volume of 100 ml plus ,An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h
Group N (Propofol)	Active comparator	Drug: PropofolIncludes thirdy patients receive an equal volume of normal saline as a placebo.plus An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. The subject is scheduled for elective colonoscopy. 2. The subject is ≥ 40 years and ≤ 70 years. 3. Both sexes. 4.No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests. 5. ASA class 1-3.

Key exclusion criteria (1 listed)

1.Subject is known or believed to be pregnant or lactating women. 2. Patients are known hypersensitivity to any of the drugs that would be used in the study. 3. Severe cardiac, renal, lung, or liver diseases. 4. Hypotension (systolic blood pressure< 90 mm Hg), uncontrolled hypertension (systolic blood pressure> 170 mmHg, diastolic blood pressure> 100mmHg). 5. Chronic Opioid Use (daily or almost daily use of opioids for> 3 months). 6. Patients that are immunologically compromised. 7. Sleep apnea syndrome or difficult airway. 8. preexisting hypoxemia (Spo2< 90 %). 9. History of adverse events with prior sedation. Additionally, patients who had taken any sedative drugs within the previous 24h

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 Sulfate40 mg/kg magnesium sulfate diluted with normal saline to a total volume of 100 ml was administered for 15 min.plus ,An initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h	Drug	Group M (Magnesium sulfate+Propofol)
PropofolAn initial bolus dose of 1 mg/kg propofol was administered over 30 is followed by a continuous intravenous infusion of propofol at a maintenance dose of 2 mg/kg/h	Drug	Group M (Magnesium sulfate+Propofol), Group N (Propofol)

Primary outcome

Total consumption of propfol
Time frame: During procedure
Calculate the total dose of propofol used for each case

1 secondary outcome

sedation time
Time frame: During procedure and One hour after procedure

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
Background: PubMed 32156544Liu J, Liu X, Peng LP, Ji R, Liu C, Li YQ. Efficacy and safety of intravenous lidocaine in propofol-based sedation for ERCP procedures: a prospective, randomized, double-blinded, controlled trial. Gastrointest Endosc. 2020 Aug;92(2):293-300. doi: 10.1016/j.gie.2020.02.050. Epub 2020 Mar 7.
Background: PubMed 29594976Lu Z, Li W, Chen H, Qian Y. Efficacy of a Dexmedetomidine-Remifentanil Combination Compared with a Midazolam-Remifentanil Combination for Conscious Sedation During Therapeutic Endoscopic Retrograde Cholangio-Pancreatography: A Prospective, Randomized, Single-Blinded Preliminary Trial. Dig Dis Sci. 2018 Jun;63(6):1633-1640. doi: 10.1007/s10620-018-5034-3. Epub 2018 Mar 29.
Background: PubMed 21364460Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.
Background: PubMed 22728648Olgun B, Oguz G, Kaya M, Savli S, Eskicirak HE, Guney I, Kadiogullari N. The effects of magnesium sulphate on desflurane requirement, early recovery and postoperative analgesia in laparascopic cholecystectomy. Magnes Res. 2012 Jul;25(2):72-8. doi: 10.1684/mrh.2012.0315.
Background: PubMed 24491463De Oliveira GS, Bialek J, Fitzgerald P, Kim JY, McCarthy RJ. Systemic magnesium to improve quality of post-surgical recovery in outpatient segmental mastectomy: a randomized, double-blind, placebo-controlled trial. Magnes Res. 2013 Oct-Dec;26(4):156-64. doi: 10.1684/mrh.2014.0349.
Results publication: PubMed 16278131Rex DK, Khalfan HK. Sedation and the technical performance of colonoscopy. Gastrointest Endosc Clin N Am. 2005 Oct;15(4):661-72. doi: 10.1016/j.giec.2005.08.003.
Results publication: PubMed 26709032Wernli KJ, Brenner AT, Rutter CM, Inadomi JM. Risks Associated With Anesthesia Services During Colonoscopy. Gastroenterology. 2016 Apr;150(4):888-94; quiz e18. doi: 10.1053/j.gastro.2015.12.018. Epub 2015 Dec 18.
Results publication: PubMed 19607937Cote GA, Hovis RM, Ansstas MA, Waldbaum L, Azar RR, Early DS, Edmundowicz SA, Mullady DK, Jonnalagadda SS. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010 Feb;8(2):137-42. doi: 10.1016/j.cgh.2009.07.008. Epub 2009 Jul 14.

Related trials for Magnesium

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Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
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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.

Mohamed Sayed Mahmoud Sayed, Master contact

01091383026 ext. 01122856977

ms0109138@gmail.com

Essam Mohamed Manna, Professor study chair

Professor of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University

Raja Ahmad Abdullah Mohamed study director

Assistant Professor of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Magnesium Sulfate and Propofol in people with Magnesium and Intraoperative Analgesia, run by Assiut University.

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 1 inclusion and 1 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Mohamed Sayed Mahmoud Sayed, Master (01091383026 ext. 01122856977, ms0109138@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total consumption of propfol (time frame: During procedure). 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 NCT06131905, which also lists 8 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 18 Dec 2023.