Effect of Dexamethasone on Post-spinal Hypotension

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Status and phase: Enrolling; Phase 4

Conditions: Geriatric Population; Orthopedic Surgeries; Post Spinal Anaesthesia Hypotension

Treatments: Other: Placebo; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06819436

ERC-000105/SMBBIT/2023

Not funded (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups, including a placebo group

Dexamethasone Group

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo