Effect of Preoperative Dexamethasone in Preventing Spinal Hypotension In Patients Undergoing Elective Caesarian Section

NCT07761585 | Completed

• 1 other identifier: LiaquatNHMC1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether giving a single dose of intravenous dexamethasone before spinal anesthesia can help prevent low blood pressure (spinal hypotension) in pregnant women undergoing elective cesarean section. Low blood pressure after spinal anesthesia is common and may cause nausea, vomiting, dizziness, and reduced blood flow to the baby. If dexamethasone works, it may help maintain stable blood pressure during surgery, reduce the need for medicines used to treat low blood pressure, and improve the safety and comfort of both the mother and baby. The main questions it aims to answer are:

• Does preoperative intravenous dexamethasone reduce the occurrence of spinal hypotension after spinal anesthesia?
• Does dexamethasone reduce the amount of vasopressor medicine needed to treat low blood pressure during surgery? Researchers will compare 8 mg intravenous dexamethasone with normal saline (placebo) to determine whether dexamethasone is more effective in preventing spinal hypotension during elective cesarean section. Participants will:
• Receive either intravenous dexamethasone or a placebo before spinal anesthesia.
• Undergo elective cesarean section under spinal anesthesia.
• Have their blood pressure monitored during surgery.
• Receive standard treatment if their blood pressure becomes too low.
• Have their blood pressure measurements and the need for blood pressure-raising medicines recorded to compare the effects of the two treatments.

Conditions

Caesarian Section

Outcome Measures

Primary Outcomes (1)

• Spinal hypotension

  The incidence of spinal hypotension, defined as a decrease in systolic blood pressure (SBP) greater than 20% of the baseline value or an absolute SBP \<90 mmHg after spinal anesthesia, will be compared between the dexamethasone and placebo groups. Blood pressure will be measured every 5 minutes until delivery of the baby.

  From spinal anesthesia until delivery of the baby (approximately 20 minutes) at 5 minutes interval for a period of 6 months.

Secondary Outcomes (1)

• Vasopressor Requirement

  From spinal anesthesia until delivery of the baby (approximately 20 minutes ) at 5 minutes interval for a period of 6 months

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Dexamethasone

Dexamethasone; Placebo

Eligibility Criteria

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

You may qualify if:

• Pregnant females Consenting No contraindications

You may not qualify if:

• Non consenting

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

Study Sites (1)

Liaquat National Hospital

Karachi, Pakistan

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 12, 2026
• Study Start: February 1, 2026
• Primary Completion: July 21, 2026
• Study Completion: July 21, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

PA (1)