Comparison Between Intrathecal Magnesium Sulphate & Dexmedetomidine in DHS

NCT07326397 | Not Yet Recruiting Phase 3

• 1 other identifier: Intrathecal Mgso4& Dex. In DHS
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the efficacy and safety of intrathecal dexmedetomidine and magnesium sulphate as adjuvants to 0.5% hyperbaric bupivacaine in patients undergoing elective DHS fixation, focusing on onset and duration of sensory and motor block, hemodynamic stability, and quality of postoperative analgesia.

Conditions

Effects of Dexmedetomidine & Magnesium Sulphate on Patients Undergoing DHS

Outcome Measures

Primary Outcomes (3)

• Highest Dermatome Level of Sensory Block

  Sensory block level assessed using a pinprick test and recorded as the highest dermatome level with loss of sensation.

  24 hours after intervention

• Duration of postoperative analgesia

  The outcome is Measured by Vas Score to assess pain intensity. It consists of a numeric version of the visual analogue scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This scale can be administered verbally. Vas score for 24 h will be assessed at 0., 1, 12 and 24 h postoperatively and will be recorded.

  24 hours after intervention

• Degree of Motor Block

  Motor block assessed using the Modified Bromage Scale (0-3), where higher scores indicate greater motor block.

  24 hours after intervention

Secondary Outcomes (4)

• Heart Rate

  24 hours after intervention

• Incidence of Adverse Effects

  24 hours after Intervention

• Mean Arterial Pressure

  24 hours after intervention

• Oxygen Saturation

  24 hours after intervention

Study Arms (2)

Group D (Dexmedetomidine)

ACTIVE COMPARATOR

Drug: Dexmedetomidine

Group M (Magnesium Sulphate)

ACTIVE COMPARATOR

Drug: Magnesium Sulphate

Interventions

Magnesium Sulphate DRUG

2.5 mL 0.5% hyperbaric bupivacaine + 50 mg magnesium sulphate (0.5 mL), total volume 3 mL

Group M (Magnesium Sulphate)

Dexmedetomidine DRUG

2.5 mL 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine (0.5 mL), total volume 3 mL

Group D (Dexmedetomidine)

Eligibility Criteria

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

You may qualify if:

• Age: 18-65 year
• ASA Physical Status I or II
• Scheduled for elective DHS fixation under spinal anesthesia
• Written informed consent provided
• Patients of both sex are included in the study.

You may not qualify if:

• Patient refusal
• Allergy to study drugs
• Local infection at injection site
• Neurological or psychiatric illness
• Coagulopathy
• Chronic opioid or sedative use

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Dexmedetomidine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Assiut University Hospital, Assiut, Egypt

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-10