Efficacy and Safety of MgSO4 as Adjuvant to Scalp BlockPhase 4NCT07075783
The Efficacy and Safety of Magnesium Sulphate Adjuvant in Scalp Block With Ropivacaine for Supratentorial Craniotomy: a Prospective, Randomized Controlled Trial
A Phase 4 study testing MgSO4 plus Ropivacaine and Plain Ropivacaine in people with Efficacy and Safety of MgSO4 as Adjuvant to Scalp Block, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
A randomized, double-blinded controlled trial was conducted to evaluate the analgesic efficacy of MgSO4 as an adjuvant to ropivacaine in scalp blocks for craniotomy, focusing on its impact on hemodynamic parameters and intraoperative remifentanil consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy and Safety of MgSO4 as Adjuvant to Scalp Block
- What is being tested?
- MgSO4 plus Ropivacaine and Plain Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Oct 2024to 20 May 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Scheduled for elective supratentorial craniotomy under general anaesthesia 2. ASA I-III physical status 3. Aged 18 years and above
Who cannot join
- 1. Traumatic brain injury 2. Aneurysmal clipping 3. GCS <14 4. Contraindication to scalp block 5. Known adverse reaction to magnesium sulphate or LA from previous exposure 6. Heart block 7. History of drug dependence or alcohol abuse 8. Pregnancy
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Pakar Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
About this study
Official title: Comparison of Efficacy of MgSO4 Added to Ropivacaine and Ropivacaine Alone in Scalp Block for Craniotomy: a Randomized Controlled Trial
A randomized, double-blinded controlled trial was conducted to evaluate the analgesic efficacy of MgSO4 as an adjuvant to ropivacaine in scalp blocks for craniotomy, focusing on its impact on hemodynamic parameters and intraoperative remifentanil consumption.
Read the detailed description
A prospective, randomized, double-blinded controlled trial was conducted at Hospital Universiti Sains Malaysia (HUSM). Twenty-four patients scheduled for elective supratentorial craniotomy under general anesthesia were randomized into two groups: the control group (ropivacaine alone) and the treatment group (ropivacaine with MgSO4). Hemodynamic parameters, including mean arterial pressure (MAP) and heart rate (HR), were recorded at seven predefined intraoperative time points corresponding to critical surgical stimuli. Total intraoperative remifentanil consumption was also measured.
- Being tested
- MgSO4 plus Ropivacaine, Plain Ropivacaine
- Keywords
- Magnesium, MgSO4, Scalp block, Craniotomy, Supratentorial, Ropivacaine, Remifentanil, Adjuvant, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MgSO4 plus RopivacaineDrug
1ml 50% MgSO4 added to 0.375% Plain Ropivacaine plus 5 mcg/ml adrenaline for scalp block
Plain RopivacaineOther
0.375% Plain Ropivacaine plus 5 mcg/ml adrenaline and 1 ml of 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Control group (RN) | Placebo comparator | •Control (RN) group: 0.375% Plain Ropivacaine at a maximum recommended dose of 3 mg/kg body weight, plus 5 mcg/ml adrenaline and 1 ml of 0.9% NaCl. Receives: Other: Plain Ropivacaine |
| Study group (RM) | Experimental | Study (RM) group: 0.375% Plain Ropivacaine at maximum recommended dose of 3 mg/kg body weight, plus 5 mcg/ml adrenaline and 1 ml of 50% MgSo4. Receives: Drug: MgSO4 plus Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure
Measured: Mean arterial blood pressure (MAP) recorded at seven time points: scalp block (T0), skull pin fixation (T1), skin incision (T2), craniotomy (T3), durotomy (T4), dura mater closure (T5) and skin closure (T6)
Heart Rate (HR)
Measured: Heart Rate (HR) recorded at seven time points: scalp block (T0), skull pin fixation (T1), skin incision (T2), craniotomy (T3), durotomy (T4), dura mater closure (T5) and skin closure (T6)
Secondary outcomes (1)
Cumulative remifentanil dose
Measured: Total intra-operative consumption of remifentanil
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start3 Oct 2024
- Primary completion15 Apr 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and Safety of MgSO4 as Adjuvant to Scalp BlockStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alwyn Lee Chee Yuan, Hospital Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075783
- Sponsor's protocol ID
- USM/JEPeM/KK/23110854
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of MgSO4 Added to Ropivacaine and Ropivacaine Alone in Scalp Block for Craniotomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07075783
- Acronym / sponsor ID
- USM/JEPeM/KK/23110854
- Keywords
- Magnesium, MgSO4, Scalp block, Craniotomy, Supratentorial, Ropivacaine, Remifentanil, Adjuvant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 20 Jul 2025 (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.
A randomized, double-blinded controlled trial was conducted to evaluate the analgesic efficacy of MgSO4 as an adjuvant to ropivacaine in scalp blocks for craniotomy, focusing on its impact on hemodynamic parameters and intraoperative remifentanil consumption.
Detailed description
A prospective, randomized, double-blinded controlled trial was conducted at Hospital Universiti Sains Malaysia (HUSM). Twenty-four patients scheduled for elective supratentorial craniotomy under general anesthesia were randomized into two groups: the control group (ropivacaine alone) and the treatment group (ropivacaine with MgSO4). Hemodynamic parameters, including mean arterial pressure (MAP) and heart rate (HR), were recorded at seven predefined intraoperative time points corresponding to critical surgical stimuli. Total intraoperative remifentanil consumption was also measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (RN) | Placebo comparator | Other: Plain Ropivacaine•Control (RN) group: 0.375% Plain Ropivacaine at a maximum recommended dose of 3 mg/kg body weight, plus 5 mcg/ml adrenaline and 1 ml of 0.9% NaCl. |
| Study group (RM) | Experimental | Drug: MgSO4 plus RopivacaineStudy (RM) group: 0.375% Plain Ropivacaine at maximum recommended dose of 3 mg/kg body weight, plus 5 mcg/ml adrenaline and 1 ml of 50% MgSo4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Scheduled for elective supratentorial craniotomy under general anaesthesia 2. ASA I-III physical status 3. Aged 18 years and above
Key exclusion criteria (1 listed)
- 1. Traumatic brain injury 2. Aneurysmal clipping 3. GCS <14 4. Contraindication to scalp block 5. Known adverse reaction to magnesium sulphate or LA from previous exposure 6. Heart block 7. History of drug dependence or alcohol abuse 8. Pregnancy
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 |
|---|---|---|
| MgSO4 plus Ropivacaine1ml 50% MgSO4 added to 0.375% Plain Ropivacaine plus 5 mcg/ml adrenaline for scalp block | Drug | Study group (RM) |
| Plain Ropivacaine0.375% Plain Ropivacaine plus 5 mcg/ml adrenaline and 1 ml of 0.9% NaCl | Other | Control group (RN) |
Primary outcome
Mean Arterial Pressure
Time frame: Mean arterial blood pressure (MAP) recorded at seven time points: scalp block (T0), skull pin fixation (T1), skin incision (T2), craniotomy (T3), durotomy (T4), dura mater closure (T5) and skin closure (T6)
Heart Rate (HR)
Time frame: Heart Rate (HR) recorded at seven time points: scalp block (T0), skull pin fixation (T1), skin incision (T2), craniotomy (T3), durotomy (T4), dura mater closure (T5) and skin closure (T6)
1 secondary outcome
Cumulative remifentanil dose
Time frame: Total intra-operative consumption of remifentanil
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MgSO4 plus Ropivacaine and Plain Ropivacaine in people with Efficacy and Safety of MgSO4 as Adjuvant to Scalp Block, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
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: finished, as of the sponsor's last update on 20 Jul 2025. 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 Malaysia. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (time frame: Mean arterial blood pressure (MAP) recorded at seven time points: scalp block (T0), skull pin fixation (T1), skin incision (T2), craniotomy (T3), durotomy (T4), dura mater closure (T5) and skin closure (T6)). The study lists 2 primary outcomes in all. 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 Jul 2025.