Actively Recruiting

Phase 4
Age: 65Years - 85Years
All Genders
Healthy Volunteers
ID06819436

Effect of Dexamethasone on Post-spinal Hypotension in Geriatric Patients Undergoing Orthopaedic Surgery at Tertiary Care Hospital Karachi

Led by Shaheed Mohtarma Benazir Bhutto Institue of Trauma · Updated on 2025-02-11

170

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial investigates whether intravenous dexamethasone can prevent low blood pressure after spinal anesthesia in older adults having orthopedic surgeries on their lower limbs. Researchers aim to see if giving dexamethasone before surgery reduces post-spinal hypotension compared to a placebo. The study focuses on geriatric patients aged 65 to 85 years undergoing these procedures. Participants are randomly assigned to one of two groups. One group receives an 8 mg dose of intravenous dexamethasone about 20 minutes before spinal anesthesia. The other group receives a placebo intravenously at the same time before the spinal anesthesia. This is a phase 4, single-blind, randomized study conducted at a tertiary care hospital. During the trial, participants' blood pressure is monitored from enrollment until 30 minutes after spinal anesthesia to assess the occurrence of hypotension. Researchers will compare the effects of dexamethasone versus placebo on this outcome. The total participation duration includes preoperative administration and monitoring immediately after spinal anesthesia. Safety and other assessments are performed as part of routine care during this period.

CONDITIONS

Brief Title

Effect of Dexamethasone on Post-spinal Hypotension

Who Can Participate

Age: 65Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient undergoing orthopedic surgery in spinal anesthesia
  • ASA physical status classification of 2 or less
  • Age between 65 and 85 years
Not Eligible

You will not qualify if you...

  • History of cardiac arrhythmias
  • History of acute coronary syndrome
  • History of polytrauma
  • Contraindications to spinal anesthesia such as coagulopathy, thrombocytopenia, or allergy to local anesthetic agents
  • Current use of steroids or serotonin-related medications such as selective serotonin reuptake inhibitors (SSRIs)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From preoperative dosing to 30 minutes after spinal anesthesia

Participants receive intravenous dexamethasone or placebo 20 minutes before spinal anesthesia as part of orthopedic surgery.

1 treatment visit (in-person)

Trial Site Locations

Total: 1 location

1

Shaheed Mohtarma Benazir Bhutto Institute of Trauma

Karachi, Sindh, Pakistan

Actively Recruiting

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Research Team

S

Sidra Javed, MBBS, FCPS, Pain fellow

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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