Muscle RelaxationPhase 2/3MgSO4/CisANCT05757999
Effect of MgSO4 Pretreatment on Muscle Relaxation
A Phase 2/3 study testing Magnesium Sulphate and Saline in people with Muscle Relaxation, run by Assiut University at 1 site in Egypt.
Trial summary
In this study, the effect of magnesium sulphate on the onset and duration of intense and moderate cis-atracurium induced neuromuscular blocking and on the period of no response to nerve stimulation will be evaluated in patients who will recieve magnesium sulphate (intervention group) and patients who will not recieve… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Muscle Relaxation
- What is being tested?
- Magnesium Sulphate and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jul 2023to May 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group 18-60 years old
- Both genders
- Patients who will be scheduled to undergo elective otorhinolaryngological surgery.
- Patients with BMI between 18.5 and 24.9 Kg/m2.
- Patients with American Society of Anesthesiologist physical status classification of 1 or 2
Who cannot join
- Patients who are less than 18 years old or more than 60 years old.
- Patients on medications that interfered with muscle activity.
- Allergy to medications used in this study.
- Pregnancy or suspected pregnancy.
- Neuro-muscular diseases.
- Renal or hepatic impairment.
- Hypermagnesemia (>2.5 mmol) or hypomagnesemia (<1.7 mmol).
- Patients refusing to study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university main hospital, ENT operative theatre
Asyut, Asyut Governorate, 71515
Hala S Abdel-Ghaffar, MD, 01003812011 ext. +20, hallasaad@yahoo.com
Abu El Hassan A Rezk, MBBCh, 01026067713 ext. +20, drhassanramadan96@gmail.com
About this study
Official title: Effect of Magnesium Sulphate Pretreatment on Cis-Atracurium Induced Neuromuscular Block and Recovery Characteristics: A Randomized Controlled Trial.
In this study, the effect of magnesium sulphate on the onset and duration of intense and moderate cis-atracurium induced neuromuscular blocking and on the period of no response to nerve stimulation will be evaluated in patients who will recieve magnesium sulphate (intervention group) and patients who will not recieve magnesium sulphate (comparator group).
Read the detailed description
General anesthesia is a drug-induced reversible state consisting of unconsciousness, amnesia, anti-nociception, and immobility, with maintenance of physiological stability. Balanced general anesthesia, the most common management strategy used in anesthesia care, entails administering a combination of different agents to create the anesthetic state. There is evidence that balanced general anesthesia uses less of each drug than if the drug were administered alone. This approach is believed to increase the likelihood of a drug's desired effects and reduce the likelihood of its side effects. With addition of adjuvants, Alpha-2 adrenoceptor agonists, such as dexmedetomidine, are known to possess amnesic, analgesic, sympatholytic, and antinociceptive properties, and therefore, can reduce the requirement of anesthetics and opioids intraoperatively. Administration of MgSO4 has also shown significant reduction in the perioperative requirement of propofol, opioids, and muscle relaxants. Magnesium sulphate has gained prominence as an adjuvant drug in multimodal anesthesia and pain medicine. It has several clinical indications including attenuation of the adrenergic response to tracheal intubation and improved peri-operative analgesia. Magnesium sulphate also enhances the action of non-depolarizing neuromuscular blocking drugs, resulting in potentiation of neuromuscular blockade (NMB).The site of magnesium potentiation of neuromuscular blocking drugs is the motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, limited data exist concerning the effect of magnesium sulphate on the duration of deep or intense NMB and on the period of no response to nerve stimulation.
- Conditions
- Muscle Relaxation
- Being tested
- Magnesium Sulphate, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulphateDrug
Also called MgSo4
A magnesium sulphate infusion (60 mg kg-1, total volume 100 ml, infusion rate 10 ml min-1) will be administered to patients 10 min. before induction of anesthesia.
SalineDrug
Also called Placebo Comparator
The patients will be pretreated with an intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) 10 min before induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| MgSo4 | Active comparator | A magnesium sulphate infusion (60 mg kg-1, total volume 100 ml, infusion rate 10 ml min-1) 10 min. will be administered before induction of anesthesia Receives: Drug: Magnesium Sulphate |
| Saline Placebo | Placebo comparator | an intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) 10 min. will be administered before induction of anesthesia. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of the period of no response.
The effect of pretreatment with magnesium sulphate on the duration of the period of no response will be measured with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). The ulnar nerve near the wrist will be stimulated and the activity of the adductor pollicis (thumb) muscle will be recorded.
Measured: Intraoperative.
Secondary outcomes (2)
The duration of intense neuromuscular block (minutes)
The effect of pretreatment with magnesium sulphate on the duration of the intense neuromuscular block in minutes will be measured with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). The ulnar nerve near the wrist will be stimulated and the activity of the adductor pollicis (thumb) muscle will be recorded.
Measured: Intraoperative
The duration of deep neuromuscular block
The effect of pretreatment with magnesium sulphate on the duration of the deep neuromuscular block in minutes will be measured with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). The ulnar nerve near the wrist will be stimulated and the activity of the adductor pollicis (thumb) muscle will be recorded.
Measured: Intraoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start23 Jul 2023
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be allocated to one of two groups: a saline placebo group (n=50) or a magnesium group (n=50). The patients will be pretreated with either an intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) or a magnesium sulphate infusion (60 mg kg-1, total volume 100 ml, infusion rate 10 ml min-1) 10 min. before induction of anesthesia. Allocation numbers will be placed in opaque envelopes and opened by an anesthesiologist (not participating in the study)who will also prepare the study solutions.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala Abdel-Ghaffar, MD, Principal investigator, Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757999
- Sponsor's protocol ID
- 04-2023-200100
- Acronym
- MgSO4/CisA
- Status last verified
- Jun 2024
- First submitted
- 19 Feb 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulphate Pretreatment on Cis-Atracurium Induced Neuromuscular Block and Recovery Characteristics: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05757999
- Acronym / sponsor ID
- MgSO4/CisA / 04-2023-200100
- Conditions
- Muscle Relaxation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 23 Jul 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 7 Mar 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.
In this study, the effect of magnesium sulphate on the onset and duration of intense and moderate cis-atracurium induced neuromuscular blocking and on the period of no response to nerve stimulation will be evaluated in patients who will recieve magnesium sulphate (intervention group) and patients who will not recieve magnesium sulphate (comparator group).
Detailed description
General anesthesia is a drug-induced reversible state consisting of unconsciousness, amnesia, anti-nociception, and immobility, with maintenance of physiological stability. Balanced general anesthesia, the most common management strategy used in anesthesia care, entails administering a combination of different agents to create the anesthetic state. There is evidence that balanced general anesthesia uses less of each drug than if the drug were administered alone. This approach is believed to increase the likelihood of a drug's desired effects and reduce the likelihood of its side effects. With addition of adjuvants, Alpha-2 adrenoceptor agonists, such as dexmedetomidine, are known to possess amnesic, analgesic, sympatholytic, and antinociceptive properties, and therefore, can reduce the requirement of anesthetics and opioids intraoperatively. Administration of MgSO4 has also shown significant reduction in the perioperative requirement of propofol, opioids, and muscle relaxants. Magnesium sulphate has gained prominence as an adjuvant drug in multimodal anesthesia and pain medicine. It has several clinical indications including attenuation of the adrenergic response to tracheal intubation and improved peri-operative analgesia. Magnesium sulphate also enhances the action of non-depolarizing neuromuscular blocking drugs, resulting in potentiation of neuromuscular blockade (NMB).The site of magnesium potentiation of neuromuscular blocking drugs is the motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, limited data exist concerning the effect of magnesium sulphate on the duration of deep or intense NMB and on the period of no response to nerve stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be allocated to one of two groups: a saline placebo group (n=50) or a magnesium group (n=50). The patients will be pretreated with either an intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) or a magnesium sulphate infusion (60 mg kg-1, total volume 100 ml, infusion rate 10 ml min-1) 10 min. before induction of anesthesia. Allocation numbers will be placed in opaque envelopes and opened by an anesthesiologist (not participating in the study)who will also prepare the study solutions.
| Arm | Type | Receives |
|---|---|---|
| MgSo4 | Active comparator | Drug: Magnesium SulphateA magnesium sulphate infusion (60 mg kg-1, total volume 100 ml, infusion rate 10 ml min-1) 10 min. will be administered before induction of anesthesia |
| Saline Placebo | Placebo comparator | Drug: Salinean intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) 10 min. will be administered before induction of anesthesia. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group 18-60 years old
- Both genders
- Patients who will be scheduled to undergo elective otorhinolaryngological surgery.
- Patients with BMI between 18.5 and 24.9 Kg/m2.
- Patients with American Society of Anesthesiologist physical status classification of 1 or 2
Key exclusion criteria (8 listed)
- Patients who are less than 18 years old or more than 60 years old.
- Patients on medications that interfered with muscle activity.
- Allergy to medications used in this study.
- Pregnancy or suspected pregnancy.
- Neuro-muscular diseases.
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 SulphateAlso: MgSo4A magnesium sulphate infusion (60 mg kg-1, total volume 100 ml, infusion rate 10 ml min-1) will be administered to patients 10 min. before induction of anesthesia. | Drug | MgSo4 |
| SalineAlso: Placebo ComparatorThe patients will be pretreated with an intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) 10 min before induction of anesthesia. | Drug | Saline Placebo |
Primary outcome
The duration of the period of no response.
Time frame: Intraoperative.
The effect of pretreatment with magnesium sulphate on the duration of the period of no response will be measured with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). The ulnar nerve near the wrist will be stimulated and the activity of the adductor pollicis (thumb) muscle will be recorded.
2 secondary outcomes
The duration of intense neuromuscular block (minutes)
Time frame: Intraoperative
The duration of deep neuromuscular block
Time frame: Intraoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- 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.
Hala Abdel-Ghaffar, MD principal investigator
Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnesium Sulphate and Saline in people with Muscle Relaxation, run by Assiut University 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 5 inclusion and 8 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 1 Jul 2024. 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.
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 Hala S Abdel-Ghaffar, MD (01003812011 ext. +20, hallasaad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of the period of no response. (time frame: Intraoperative.). 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 1 Jul 2024.