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

NCT07075783 | Completed Phase 4

• 1 other identifier: USM/JEPeM/KK/23110854
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Efficacy and Safety of MgSO4 as Adjuvant to Scalp Block

Keywords

Magnesium; MgSO4; Scalp block; Craniotomy; Supratentorial; Ropivacaine; Remifentanil; Adjuvant; Efficacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cumulative remifentanil dose

  Total intra-operative consumption of remifentanil

Study Arms (2)

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.

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.

Drug: MgSO4 plus Ropivacaine

Interventions

MgSO4 plus Ropivacaine DRUG

1ml 50% MgSO4 added to 0.375% Plain Ropivacaine plus 5 mcg/ml adrenaline for scalp block

Study group (RM)

Plain Ropivacaine OTHER

0.375% Plain Ropivacaine plus 5 mcg/ml adrenaline and 1 ml of 0.9% NaCl

Control group (RN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Scheduled for elective supratentorial craniotomy under general anaesthesia 2. ASA I-III physical status 3. Aged 18 years and above

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Pakar Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: October 3, 2024
• Primary Completion: April 15, 2025
• Study Completion: May 20, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

MY (1)