Muscle RelaxationPhase 2/3MgSO4/MRNCT05736744
Effect of Magnesium Sulphate Pretreatment in Pediatric Abdominal Surgery
A Phase 2/3 study testing MgSO4 and Cis-Atracurium in people with Muscle Relaxation, run by Assiut University at 2 sites in Egypt.
Trial summary
In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Muscle Relaxation
- What is being tested?
- MgSO4 and Cis-Atracurium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Jun 2023to 1 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age group 2-12 years old
- Both genders
- Children who will be scheduled to undergo elective laparoscopic surgeries.
- Patients with American Society of Anesthesiologist physical status classification of 1 or 2-
Who cannot join
- Patients who are beyond the selected age group.
- Patients on medications that interfered with muscle activity.
- Allergy to medications used in this study.
- Neuro-muscular diseases.
- Renal or hepatic impairment.
- Hypermagnesemia (>2.5 mmol) or hypomagnesemia (<1.7 mmol).
- Parental refusal to participate in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Pediatric hospital, faculty of medicine, Assiut university
Asyut, Assiut Governorate, 715715
Hala S Abdelghaffar, MD, +201003812011, hallasaad@yahoo.com
- Recruiting
Pediatric hospital
Asyut, Assiut Governorate, 715715
Hala S Abdel-Ghaffar, MD, 01003812011 ext. +2 088, hallasaad@yahoo.com
Heba S Hassan, Master, 01146705556, hebaammar@gmail.com
About this study
Official title: Effect of Magnesium Sulphate Pretreatment on the Onset and Duration of Intense and Deep Neuromuscular Block of Rocuronium Versus Cis-Atracurium in Pediatric Abdominal Surgery
In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries.
Read the detailed description
Deep neuromuscular blockade is known to improve surgical conditions in procedures such as abdominal or pelvic laparoscopic surgery, laparotomy and laryngeal surgery. In addition, deep neuromuscular blockade enables a reduction in pneumoperitoneal pressure, postoperative pain and the incidence of intra-operative and postoperative adverse events. Correspondingly, the use of deep neuromuscular blockade is increasing, and for its maintenance neuromuscular monitoring is essential; the use of neostigmine may also be helpful in achieving a rapid recovery. 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. In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries.
- Conditions
- Muscle Relaxation
- Being tested
- MgSO4, Cis-Atracurium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MgSO4Drug
Also called Magnesium Sulfate
The patients will be pretreated with magnesium sulphate infusion (30 mg kg-1, total volume 100 ml, infusion rate 5 ml min-1) 20 min. before induction of anesthesia.
Cis-AtracuriumDrug
Also called Nimbex
Cis-Atracurium will be administered at 0.1-0.15 mg/kg IV bolus for intubation and maintenance at a dose of 0.03 mg/kg iv on fixed intervals.
| Study group | Role | What they receive |
|---|---|---|
| Cis/atracurium/saline placebo | Placebo comparator | 1. The patients will receive 100 ml saline 0.9% at an infusion rate 5 ml/min-1) administered 20 min. before induction of anesthesia.
2. cisatracurium will be administered for intubation at a dose of 0.15 mg/kg IV and Maintenance at a dose of 0.03 mg/kg IV Receives: Drug: Cis-Atracurium |
| Cis-Atracurium/MgSO4 | Active comparator | 1. The patients will be pretreated with magnesium sulphate infusion (30 mg kg-1, total volume 100 ml, infusion rate 5 ml min-1) 20 min. before induction of anesthesia.
2. Cis-Atracurium will be administered at 0.1-0.15 mg/kg IV bolus for intubation and maintenance at a dose of 0.03 mg/kg iv on fixed intervals. Receives: Drug: MgSO4; Drug: Cis-Atracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of no response to nerve stimulation (seconds)
Neuromuscular monitoring will be performed using acceleromyography with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). Period of no response will be defined as the time period with no response to TOF stimulation (intense and deep NMB).
Measured: Intraoperative
Secondary outcomes (3)
Duration of deep NMB (seconds)
The time period from the reappearance of the first response to PTC stimulation to the reappearance of the first response to TOF stimulation.
Measured: Intraoperative
The duration of moderate NMB (seconds)
the time period from the reappearance of the first response to PTC stimulation to the reappearance of the first response to TOF stimulation one to three out of four twitches.
Measured: Intraoperative.
NMB onset time (in seconds).
The time elapsed, in minutes, from the start of the administration of muscle relaxant; cis-atracurium or rocuronium injection to 95% of T1 depression.
Measured: Intraoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start20 Jun 2023
- Primary completion20 Feb 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.
- 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
- To compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective laparoscopic surgeries.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 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
- NCT05736744
- Sponsor's protocol ID
- 04-2022-200028
- Acronym
- MgSO4/MR
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2023
- Last updated
- 20 Jan 2025
- 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulphate Pretreatment on the Onset and Duration of Intense and Deep Neuromuscular Block of Rocuronium Versus Cis-Atracurium in Pediatric Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05736744
- Acronym / sponsor ID
- MgSO4/MR / 04-2022-200028
- Conditions
- Muscle Relaxation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Feb 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 investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries.
Detailed description
Deep neuromuscular blockade is known to improve surgical conditions in procedures such as abdominal or pelvic laparoscopic surgery, laparotomy and laryngeal surgery. In addition, deep neuromuscular blockade enables a reduction in pneumoperitoneal pressure, postoperative pain and the incidence of intra-operative and postoperative adverse events. Correspondingly, the use of deep neuromuscular blockade is increasing, and for its maintenance neuromuscular monitoring is essential; the use of neostigmine may also be helpful in achieving a rapid recovery. 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. In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective laparoscopic surgeries.
| Arm | Type | Receives |
|---|---|---|
| Cis/atracurium/saline placebo | Placebo comparator | Drug: Cis-Atracurium1. The patients will receive 100 ml saline 0.9% at an infusion rate 5 ml/min-1) administered 20 min. before induction of anesthesia. 2. cisatracurium will be administered for intubation at a dose of 0.15 mg/kg IV and Maintenance at a dose of 0.03 mg/kg IV |
| Cis-Atracurium/MgSO4 | Active comparator | Drug: MgSO4, Drug: Cis-Atracurium1. The patients will be pretreated with magnesium sulphate infusion (30 mg kg-1, total volume 100 ml, infusion rate 5 ml min-1) 20 min. before induction of anesthesia. 2. Cis-Atracurium will be administered at 0.1-0.15 mg/kg IV bolus for intubation and maintenance at a dose of 0.03 mg/kg iv on fixed intervals. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age group 2-12 years old
- Both genders
- Children who will be scheduled to undergo elective laparoscopic surgeries.
- Patients with American Society of Anesthesiologist physical status classification of 1 or 2-
Key exclusion criteria (7 listed)
- Patients who are beyond the selected age group.
- Patients on medications that interfered with muscle activity.
- Allergy to medications used in this study.
- Neuro-muscular diseases.
- Renal or hepatic impairment.
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 |
|---|---|---|
| MgSO4Also: Magnesium SulfateThe patients will be pretreated with magnesium sulphate infusion (30 mg kg-1, total volume 100 ml, infusion rate 5 ml min-1) 20 min. before induction of anesthesia. | Drug | Cis-Atracurium/MgSO4 |
| Cis-AtracuriumAlso: NimbexCis-Atracurium will be administered at 0.1-0.15 mg/kg IV bolus for intubation and maintenance at a dose of 0.03 mg/kg iv on fixed intervals. | Drug | Cis-Atracurium/MgSO4, Cis/atracurium/saline placebo |
Primary outcome
The time of no response to nerve stimulation (seconds)
Time frame: Intraoperative
Neuromuscular monitoring will be performed using acceleromyography with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). Period of no response will be defined as the time period with no response to TOF stimulation (intense and deep NMB).
3 secondary outcomes
Duration of deep NMB (seconds)
Time frame: Intraoperative
The duration of moderate NMB (seconds)
Time frame: Intraoperative.
NMB onset time (in seconds).
Time frame: Intraoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- 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.
Hala Abdel-Ghaffar, MD principal investigator
Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.
2 sites 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 MgSO4 and Cis-Atracurium in people with Muscle Relaxation, run by Assiut University at 2 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hala S Abdel-Ghaffar, MD (01003812011, hallasaad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of no response to nerve stimulation (seconds) (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 20 Jan 2025.