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Clinical trial

Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy

ID
Name
Intrathecal MgSO4
Description
The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications.
Trial arms
Trial start
2024-06-01
Estimated PCD
2026-10-01
Trial end
2026-11-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Magnesium sulfate
IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine
Arms:
intrathecal, intravenous, placebo
Size
90
Primary endpoint
effect on postoperative pain after abdominal hysterectomy using visual analog score
Baseline
Eligibility criteria
Inclusion Criteria: * Patients between 40-65 years old * Patients with ASA clinical status I/II * Patients eligible for abdominal hysterectomy * Oncological surgery Exclusion Criteria: * Body mass index (BMI) ≥ 40/kg / m2 * Previous abdominal surgery (except cesarean section) * Severe cardiovascular, renal, and hepatic dysfunction * Contraindications to spinal anesthesia * Neuromuscular diseases * Inappropriate for spinal anesthesia * Patient refusal
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-05-29

1 organization

1 product

1 indication

Organization
Assiut University
Product
Magnesium sulfate
Indication
Abdominal Hysterectomy