Effect of Dexamethasone on Post-spinal Hypotension

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

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.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Surgeries; Geriatric Population; Post Spinal Anaesthesia Hypotension
• Intervention / Treatment: Drug: Dexamethasone; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sidra Javed, MBBS, FCPS, Pain fellow; Phone Number: +92333 2474831; Email: sidra_dow@yahoo.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Recruiting
      • Shaheed Mohtarma Benazir Bhutto Institute of Trauma
      • Contact: Maria Shafi, MBBS, MCPS
      • Contact: Sidra Tahir, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone Group; Participants randomly allocated to this group will receive intravenous dexamethasone 8mg preoperatively 20 minutes before spinal anesthesia	Drug: Dexamethasone; Intravenous dexamethasone 8mg given to participants before spinal anesthesia
Placebo Comparator: Placebo Group; Participants randomly allocated to this group will receive placebo preoperatively 20 minutes before spinal anesthesia	Other: Placebo; Intravenous placebo given to the participants before spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: ERC-000105/SMBBIT/2023; Not funded (Other Identifier: Not funded)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No