The Efficacy and Safety of Magnesium Sulphate Adjuvant in Scalp Block With Ropivacaine for Supratentorial Craniotomy: a Prospective, Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Efficacy and Safety of MgSO4 as Adjuvant to Scalp Block
• Interventions: Other: Plain Ropivacaine; Drug: MgSO4 plus Ropivacaine

• Registration Number: NCT07075783
• Lead Sponsor: Hospital Universiti Sains Malaysia

Brief 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.

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 Timeline

• Study Start: 2024-10-03
• Primary Completion: 2025-04-15
• Study Completion: 2025-05-20
• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (RN)	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)	MgSO4 plus Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
Mean Arterial Pressure	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)	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

Name	Time	Method
Cumulative remifentanil dose	Total intra-operative consumption of remifentanil

Trial Locations

Locations (1)

Hospital Pakar Universiti Sains Malaysia; 🇲🇾 Kubang Kerian, Kelantan, Malaysia