IV Dexamethasone in Preventing Post Spinal Hypotension

NCT07052864 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: F.5-2/2024(ERRC)/PIMS
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Orthopedic lower limb procedures are carried out under spinal anesthesia which involves administration of drugs in the space surrounding the spinal cord. From there the drug acts on the spinal cord blocking electrical signals moving across nerve fibers thereby providing sufficient pain relief and surgical conditions. However blocking of these fibers result in reduce signal transmission to blood vessels and heart resulting in fall in blood pressure. Various drugs can be used to treat or prevent this hypotension. One such drug is Dexamethasone which is a steroid. This drug can be administered before spinal anesthesia through Intravenous route to prevent fall in blood pressure.

Conditions

Hypotension During Surgery

Outcome Measures

Primary Outcomes (3)

• Systolic Blood Pressure

  This is the highest blood pressure during cardiac cycle occurring at the peak of systole measured by Non invasive automated blood pressure cuff

  baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins

• Diastolic Blood Pressure

  This is the lowest blood pressure during cardiac cycle measured by Non invasive automated blood pressure cuff

  baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins

• Mean Blood Pressure

  This is the average blood pressure during cardiac cycle measured by Non invasive automated blood pressure cuff

  baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins

Secondary Outcomes (3)

• Number of Hypotensive episodes

  Intraoperative period

• Rescue Phenylephrine

  Intraoperative period

• Rescue intravenous fluid

  Intraoperative period

Study Arms (2)

Group Dexamethasone

EXPERIMENTAL

Participants entering this arm of Parallel randomized control trial will receive 8mg of IV Dexamethasone in 100ml Normal saline 1 hour before induction of spinal anesthesia.

Drug: Dexamethasone

Group Placebo

PLACEBO COMPARATOR

Participants entering this arm of Parallel randomized control trial will receive 100ml Normal saline 1 hour before induction of spinal anesthesia.

Drug: Placebo

Interventions

Dexamethasone DRUG

8 mg of Intravenous Dexamethasone in 100 ml Normal saline given 1 hour before anesthesia induction

Group Dexamethasone

Placebo DRUG

100ml of Normal saline administration 1 hour before anesthesia induction

Also known as: Normal Saline

Group Placebo

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing orthopedic surgery under spinal anaesthesia.
• ASA I \& II.

You may not qualify if:

• Known case of ischemic heart disease.
• Patients having contraindication to spinal anesthesia (e.g.- coagulopathy, thrombocytopenia, allergy to local anesthetic agent).
• Patients using corticosteroids or drugs that affect serotonin (e.g., selective serotonin reuptake inhibitor).
• Patients with uncorrected hypovolemia.

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (1)

• Ashoor TM, Hussien NS, Anis SG, Esmat IM. Dexamethasone blunts postspinal hypotension in geriatric patients undergoing orthopedic surgery: a double blind, placebo-controlled study. BMC Anesthesiol. 2021 Jan 11;21(1):11. doi: 10.1186/s12871-021-01232-w.

  PMID: 33430772 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Dexamethasone; Saline Solution

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

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

Model Details: After taking informed consent participants will be divided into two equal groups using computer generated random numbers. The participants in group D will receive 8 mg of IV Dexamethasone in 100ml Normal saline 1 hour before induction of spinal anesthesia while participants in group C will receive 100ml of Normal saline 1 hour before induction of spinal anesthesia. 1 hour after administration of IV Dexamethasone or placebo patient will be brought into OR, ASA monitoring will be attached, Sub Arachnoid block will be induced with 15mg of hyperbaric bupivacaine, patient will be made to lie down, level of block will be assessed and surgery will be started. Intraoperatively hemodynamics will be recorded at 5 minutes interval for first 30 minutes. Any fall in blood pressure by more than 20% from baseline will be noted and treated with Phenylephrine IV bolus.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 7, 2025
• Study Start: June 30, 2025
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)