Effect of Dexamethasone on Post-spinal Hypotension

NCT06819436 | Recruiting Phase 4

• 2 other identifiers: ERC-000105/SMBBIT/2023Not funded
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Spinal Anaesthesia Hypotension; Geriatric Population; Orthopedic Surgeries

Outcome Measures

Primary Outcomes (1)

• Post spinal Anesthesia Hypotension

  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.

  From enrollment to 30 minutes after spinal anesthesia

Study Arms (2)

Dexamethasone Group

EXPERIMENTAL

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

Drug: Dexamethasone

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Dexamethasone DRUG

Intravenous dexamethasone 8mg given to participants before spinal anesthesia

Dexamethasone Group

Placebo OTHER

Intravenous placebo given to the participants before spinal anesthesia

Placebo Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaheed Mohtarma Benazir Bhutto Institue of Trauma: lead

Study Sites (1)

Shaheed Mohtarma Benazir Bhutto Institute of Trauma

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Sidra Javed, MBBS, FCPS, Pain fellow

CONTACT

+92333 2474831; sidra_dow@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: February 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

PA (1)