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Active, Not Recruiting

NCT Number: NCT07052864

IV Dexamethasone in Preventing Post Spinal Hypotension

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypotension During Surgery

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Islamabad, Federal, 44000, Pakistan

About this study

Lower limb orthopedic surgeries are carried out under Sub Arachnoid block which is associated with sympathectomy resulting in vasodilation and hypotension. The hypotension can compromise end organ perfusion and pre-disposes the person to end organ damage such as Myocardial infarction, stroke and renal injury. Therefore treatment and prevention of post spinal hypotension is one of the major goals to improve peri-operative outcomes. One such drug which can be used to prevent post spinal hypotension is Dexamethasone which can be given prophylactically to prevent post spinal hypotension as the drug causes increase in systemic vascular resistance thereby counteracting post spinal vasodilation and hypotension.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Dexamethasone

Drug

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

Placebo

Drug

100ml of Normal saline administration 1 hour before anesthesia induction

Other names: Normal Saline

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins

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

  2. Diastolic Blood Pressure

    Time frame: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins

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

  3. Mean Blood Pressure

    Time frame: baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins

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

Secondary outcomes

  1. Number of Hypotensive episodes

    Time frame: Intraoperative period

    This will be the number of times in the intraoperative period the patient experience fall in either systolic, diastolic or mean blood pressure by more than 20% from baseline

  2. Rescue Phenylephrine

    Time frame: Intraoperative period

    This will be the total amount of phenylephrine administered in intraoperative period to the patient in case of fall in either systolic, diastolic or mean blood pressure by more than 20% from baseline

  3. Rescue intravenous fluid

    Time frame: Intraoperative period

    This will be the total amount of IV crystalloid fluid administered in intraoperative period to the patient in case of fall in either systolic, diastolic or mean blood pressure by more than 20% from baseline

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

Efficacy of Dexamethasone in Preventing Postspinal Hypotension in Elderly Patients Undergoing Orthopedic Surgery: a Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2025
Registry last updated
Jul 31, 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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