IV Dexamethasone in Preventing Post Spinal Hypotension

Not Applicable

Active, not recruiting

• Conditions: Hypotension During Surgery
• Interventions: Drug: Dexamethasone; Drug: Placebo

• Registration Number: NCT07052864
• Lead Sponsor: Pakistan Institute of Medical Sciences

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-29
• Study First Submitted QC: 2025-06-29
• Study Start: 2025-06-30
• Study First Posted: 2025-07-07
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-31
• Primary Completion: 2025-08-05
• Study Completion: 2025-08-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	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
Diastolic Blood Pressure	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
Mean Blood Pressure	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 Outcome Measures

Name	Time	Method
Number of Hypotensive episodes	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
Rescue Phenylephrine	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
Rescue intravenous fluid	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

Trial Locations

Locations (1)

Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences; 🇵🇰 Islamabad, Federal, Pakistan