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

Conditions

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

  • Malaysia
    • 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.
Other: Plain Ropivacaine
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.
Drug: MgSO4 plus Ropivacaine
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.

Sponsor

Hospital Universiti Sains Malaysia

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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