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Completed

NCT Number: NCT07075783

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

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Key information

Conditions

Efficacy and Safety of MgSO4 as Adjuvant to Scalp Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Pakar Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MgSO4 plus Ropivacaine

Drug

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

Plain Ropivacaine

Other

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

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Cumulative remifentanil dose

    Time frame: Total intra-operative consumption of remifentanil

Sponsors and collaborators

Lead sponsor

Hospital Universiti Sains Malaysia

Other

Registry information

Official study title

Comparison of Efficacy of MgSO4 Added to Ropivacaine and Ropivacaine Alone in Scalp Block for Craniotomy: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.