IV Dexamethasone in Preventing Post Spinal Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2025-08-05

Brief Summary

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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.

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Detailed Description

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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

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Hypotension During Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After taking informed consent participants will be divided into two equal groups using computer generated random numbers. The participants in group D will receive 8 mg of IV Dexamethasone in 100ml Normal saline 1 hour before induction of spinal anesthesia while participants in group C will receive 100ml of Normal saline 1 hour before induction of spinal anesthesia. 1 hour after administration of IV Dexamethasone or placebo patient will be brought into OR, ASA monitoring will be attached, Sub Arachnoid block will be induced with 15mg of hyperbaric bupivacaine, patient will be made to lie down, level of block will be assessed and surgery will be started. Intraoperatively hemodynamics will be recorded at 5 minutes interval for first 30 minutes. Any fall in blood pressure by more than 20% from baseline will be noted and treated with Phenylephrine IV bolus.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group Dexamethasone

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.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

8 mg of Intravenous Dexamethasone in 100 ml Normal saline given 1 hour before anesthesia induction

Group Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100ml of Normal saline administration 1 hour before anesthesia induction

Interventions

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Dexamethasone

8 mg of Intravenous Dexamethasone in 100 ml Normal saline given 1 hour before anesthesia induction

Intervention Type DRUG

Placebo

100ml of Normal saline administration 1 hour before anesthesia induction

Intervention Type DRUG

Other Intervention Names

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Normal Saline

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes