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NCT Number: NCT06819436

Effect of Dexamethasone on Post-spinal Hypotension

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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Key information

Conditions

Post Spinal Anaesthesia Hypotension Geriatric Population Orthopedic Surgeries

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shaheed Mohtarma Benazir Bhutto Institute of Trauma

Karachi, Sindh, Pakistan

Location status: Recruiting

Location contact

Maria Shafi, MBBS, MCPS

PRINCIPAL_INVESTIGATOR

Sidra Tahir, MBBS

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

Intravenous dexamethasone 8mg given to participants before spinal anesthesia

Placebo

Other

Intravenous placebo given to the participants before spinal anesthesia

Primary outcomes

  1. Post spinal Anesthesia Hypotension

    Time frame: From enrollment to 30 minutes after spinal anesthesia

    Hypotension will be considered if there will be 25% decrease below the baseline for (Mean Arterial Pressure) MAP and will be managed by 300 ml of (Normal Saline) NS solution with incremental intravenous 5 mg doses of ephedrine. The proportion of patients with hypotension at any time during the first 20 min after induction of the (Spinal Anesthesia) SA and before starting the surgical procedure will be considered as the outcome of the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Sidra Javed, MBBS, FCPS, Pain fellow

CONTACT

[email protected]

+92333 2474831

Sponsors and collaborators

Lead sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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