IV Dexamethasone in Preventing Post Spinal Hypotension

Pakistan Institute of Medical Sciences

Status and phase: Active, not recruiting; Phase 4

Conditions: Hypotension During Surgery

Treatments: Drug: Dexamethasone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07052864

F.5-2/2024(ERRC)/PIMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing orthopedic surgery under spinal anaesthesia.
• ASA I & II.

Exclusion criteria

• Known case of ischemic heart disease.
• Patients having contraindication to spinal anesthesia (e.g.- coagulopathy, thrombocytopenia, allergy to local anesthetic agent).
• Patients using corticosteroids or drugs that affect serotonin (e.g., selective serotonin reuptake inhibitor).
• Patients with uncorrected hypovolemia.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups, including a placebo group

Group D

Experimental group

Description:

Participants entering this arm of Parallel randomized control trial will receive 8mg of IV Dexamethasone in 100ml Normal saline 1 hour before induction of spinal anesthesia.

Treatment:

Drug: Dexamethasone

Group C

Placebo Comparator group

Description:

Participants entering this arm of Parallel randomized control trial will receive 100ml Normal saline 1 hour before induction of spinal anesthesia.

Treatment:

Drug: Placebo