The Efficacy and Safety of Magnesium Sulphate Adjuvant in Scalp Block With Ropivacaine for Supratentorial Craniotomy: a Prospective, Randomized Controlled Trial
July 10, 2025 updated by: Alwyn Lee Chee Yuan, Hospital Universiti Sains Malaysia
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kelantan
-
Kubang Kerian, Kelantan, Malaysia, 16150
- Hospital Pakar Universiti Sains Malaysia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1. Scheduled for elective supratentorial craniotomy under general anaesthesia 2. ASA I-III physical status 3. Aged 18 years and above
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group (RN)
•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.
|
0.375% Plain Ropivacaine plus 5 mcg/ml adrenaline and 1 ml of 0.9% NaCl
|
|
Experimental: Study group (RM)
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.
|
1ml 50% MgSO4 added to 0.375% Plain Ropivacaine plus 5 mcg/ml adrenaline for scalp block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
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)
|
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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cumulative remifentanil dose
Time Frame: Total intra-operative consumption of remifentanil
|
Total intra-operative consumption of remifentanil
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 3, 2024
Primary Completion (Actual)
April 15, 2025
Study Completion (Actual)
May 20, 2025
Study Registration Dates
First Submitted
July 10, 2025
First Submitted That Met QC Criteria
July 10, 2025
First Posted (Actual)
July 20, 2025
Study Record Updates
Last Update Posted (Actual)
July 20, 2025
Last Update Submitted That Met QC Criteria
July 10, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USM/JEPeM/KK/23110854
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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