NCT07052864

IV Dexamethasone in Preventing Post Spinal Hypotension

Efficacy of Dexamethasone in Preventing Postspinal Hypotension in Elderly Patients Undergoing Orthopedic Surgery: a Randomized Controlled Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Pakistan Institute of Medical Sciences · Other Government
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Orthopedic lower limb procedures are carried out under spinal anesthesia which involves administration of drugs in the space surrounding the spinal cord. From there the drug acts on the spinal cord blocking electrical signals moving across nerve fibers thereby providing sufficient pain relief and surgical conditions. However blocking of these fibers result in reduce signal transmission to blood vessels and heart resulting in fall in blood pressure. Various drugs can be used to treat or prevent this hypotension. One such drug is Dexamethasone which is a steroid. This drug can be administered before spinal anesthesia through Intravenous route to prevent fall in blood pressure.

Detailed description

Lower limb orthopedic surgeries are carried out under Sub Arachnoid block which is associated with sympathectomy resulting in vasodilation and hypotension. The hypotension can compromise end organ perfusion and pre-disposes the person to end organ damage such as Myocardial infarction, stroke and renal injury. Therefore treatment and prevention of post spinal hypotension is one of the major goals to improve peri-operative outcomes. One such drug which can be used to prevent post spinal hypotension is Dexamethasone which can be given prophylactically to prevent post spinal hypotension as the drug causes increase in systemic vascular resistance thereby counteracting post spinal vasodilation and hypotension.

Conditions

• Hypotension During Surgery

Interventions

Type	Name	Description
DRUG	Dexamethasone	8 mg of Intravenous Dexamethasone in 100 ml Normal saline given 1 hour before anesthesia induction
DRUG	Placebo	100ml of Normal saline administration 1 hour before anesthesia induction

Timeline

• Start date: 2025-06-30
• Primary completion: 2025-08-05
• Completion: 2025-08-05
• First posted: 2025-07-07
• Last updated: 2025-07-31

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study