Effect of Dexamethasone on 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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2025-05-31

Brief Summary

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The goal of this clinical trial is to learn if intravenous dexamethasone is effective for prevention of post spinal hypotension in geriatric population undergoing orthopedic surgeries. The main question aim to answer is:

Does intravenous dexamethasone in participants undergoing orthopedic procedures of lower limb under spinal anesthesia prevents post spinal hypotension? Researchers are comparing two groups of participants

* Participants in (Dexamethasone Group) Group D are receiving intravenous dexamethasone 8mg preoperatively
* Participants in (Placebo Group) Group P are receiving placebo preoperatively.

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Detailed Description

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Conditions

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Post Spinal Anaesthesia Hypotension Geriatric Population Orthopedic Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Dexamethasone Group

Participants randomly allocated to this group will receive intravenous dexamethasone 8mg preoperatively 20 minutes before spinal anesthesia

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Intravenous dexamethasone 8mg given to participants before spinal anesthesia

Placebo Group

Participants randomly allocated to this group will receive placebo preoperatively 20 minutes before spinal anesthesia

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Intravenous placebo given to the participants before spinal anesthesia

Interventions

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Dexamethasone

Intravenous dexamethasone 8mg given to participants before spinal anesthesia

Intervention Type DRUG

Placebo

Intravenous placebo given to the participants before spinal anesthesia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patient undergoing orthopedic surgery in spinal anesthesia. ASA ≤ 2.

Exclusion Criteria

Patients with history of cardiac arrhythmias. Patients with history of acute coronary syndrome. Patient with history of polytrauma. Patients with contraindication to SA (e.g., coagulopathy, thrombocytopenia, allergy to local anesthetic agent) and those on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor) will be excluded.

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes