Dexamethasone in Prolonging the Duration of Spinal Anesthesia Among Pregnant Patients

NCT07088146 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 201/IREF/RMU/2025
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Lower segment C section is one of the most commonly performed surgeries worldwide. It is performed in spinal anesthesia. During Spinal Anesthesia a local anesthetic drug is administered in a space surrounding spinal cord and it blocks nerves originating from spinal cord providing both anesthesia and analgesia. This technique avoids harmful exposure of drugs to the baby inside the womb of mother. However this technique provides anesthesia and analgesia of limited duration which can be prolonged by addition of drugs to patient management regimen. One such drug is Dexamethasone which is a steroid commonly administered in the peri-operative period.

Conditions

Spinal Anesthesia; Post Operative Analgesia

Keywords

Adjuvants; Sub-Arachnoid Block; C-section

Outcome Measures

Primary Outcomes (1)

• Time for block to regress by two dermatomes in post operative period

  This will be the time in minutes from end of C section in post operative period for the block to regress by two dermatomes

Secondary Outcomes (1)

• Time to rescue analgesia

  This will be the time in minutes from the end of Cesarean section in the post operative period to first rescue analgesia.

Study Arms (2)

Group Dexamethasone

EXPERIMENTAL

Drug: Dexamethasone

Group Control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dexamethasone DRUG

Immediately after sub-arachnoid block 8mg of Dexamethasone will be administered intravenously

Group Dexamethasone

Placebo DRUG

2ml of Normal saline will be given intravenously immediately after administration of spinal anesthesia

Group Control

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) class: II and above.
• Elective Cesarean section under Spinal Anesthesia.

You may not qualify if:

• Gestational diabetes
• Body mass index \>35 kg/m2
• Diabetes mellitus
• Adrenal insufficiency
• Chronically receiving steroids
• Allergic to study medications
• Sensory block level less than T4

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

Benazir Bhutto Hospital Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (1)

• Abdel-Wahab AH, Abd Alla ES, Abd El-Azeem T. Effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in lower abdominal surgery, Randomized controlled trial. BMC Anesthesiol. 2023 Sep 22;23(1):323. doi: 10.1186/s12871-023-02282-y.

  PMID: 37736711 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Abeera Zareen, MBBS,FCPS

  Rawalpindi Medical College

  STUDY CHAIR

Central Study Contacts

Huda Tariq, MBBS

CONTACT

+92-321-8829413; Huda8829@gmail.com

Study Design

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

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: July 20, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)