Dexamethasone and Duration of Spinal Anesthesia

NCT07819682 | Recruiting Phase 4 DMC

• 1 other identifier: 782/REF/RMU/2025
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether intravenous dexamethasone affects the duration of spinal anesthesia in patients undergoing lower abdominal surgery. Eligible adult patients classified as ASA I or II will undergo routine preoperative assessment by an anesthetist. Before surgery, patients will receive either intravenous dexamethasone (8 mg diluted in 100 mL normal saline) or 100 mL normal saline alone. The medication will be administered through a peripheral intravenous cannula. Spinal anesthesia will then be performed using a standard technique. A 25-gauge spinal needle will be used to administer 12-15 mg of 0.75% hyperbaric bupivacaine into the lower lumbar region while the patient is in the sitting position. After confirming the flow of cerebrospinal fluid, the patient will be positioned for surgery. The level and effectiveness of anesthesia will be assessed using standard sensory and motor assessments. Surgery will begin after an adequate level of numbness and motor block has been achieved. The recovery of sensory and motor function will subsequently be assessed at regular 15-minute intervals by an anesthesia team member who was not involved in administering the spinal anesthesia, to minimize assessment bias. The main outcome will be the time required for the sensory block to regress from its initial level to the lower thoracic region (T10-T12). Additional outcomes will include the total duration of sensory and motor block and postoperative pain, assessed using a visual pain scale four hours after surgery. Patient information such as age, sex, diagnosis, type of surgery, duration of sensory and motor block, and postoperative pain score will be recorded and analyzed to determine whether intravenous dexamethasone prolongs the duration of spinal anesthesia.

Conditions

Dexamethasone; Spinal Anesthesia; Adjuvant

Keywords

Dexamethasone; Lower Abdominal Surgery; Spinal Anesthesia

Outcome Measures

Primary Outcomes (2)

• Time to Spinal Anesthesia regression

  Time in minutes from administration of spinal anesthesia until sensory block regresses by two dermatomes from the maximum sensory block level.

  From administration of spinal anesthesia until sensory block regresses by two dermatomes, assessed for up to 6 hours after spinal anesthesia

• Time in minutes from administration of spinal anesthesia until the patient first requests rescue analgesia.

  From administration of spinal anesthesia until the patient's first request for rescue analgesia, assessed for up to 6 hours after spinal anesthesia.

Study Arms (2)

Group Dexamethasone

ACTIVE COMPARATOR

8mg of Dexamethasone in 100ml Normal Saline will be administered

Drug: Dexamethasone

Control group

PLACEBO COMPARATOR

Will receive 100ml of normal saline

Drug: Placebo

Interventions

Dexamethasone DRUG

Will receive 8mg of Dexamethasone in 100ml of Normal saline 10 minutes prior to induction of Anesthesia

Group Dexamethasone

Placebo DRUG

Will receive 100ml Normal saline 10 minutes prior to induction of spinal anesthesia

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing lower abdominal surgeries and orthopaedic surgeries including pelvic and lower extremity surgeries
• Patients classified as American Society of Anesthesiologists (ASA) physical status I or II

You may not qualify if:

• Patients with a history of spinal surgery, spinal instrumentation, or previous failed spinal anaesthesia
• Patients with pre-existing neurological disorders, peripheral neuropathy, or sensory/motor deficits
• Patients with known hypersensitivity or allergy to local anaesthetic agents or dexamethasone
• Patients with congenital spinal deformities or acquired spinal conditions such as advanced spondylosis or kyphoscoliosis that may interfere with neuraxial block
• Patients with contraindications to spinal anaesthesia, including coagulopathy, local infection at the injection site, or raised intracranial pressure
• Patients with diabetes mellitus, chronic steroid therapy, immunosuppression, or systemic infection (due to steroid use)
• Pregnant patients or those undergoing emergency surgeries

Sponsors & Collaborators

• Holy Family Hospital, Pakistan: lead

Study Sites (1)

Holy Family Hospital

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

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jawad Zaheer, MBBS, FCPS

  Head of Department of Anesthesiology

  STUDY CHAIR

Central Study Contacts

Tayyab Principal Investigator, MBBS

CONTACT

+92 308 5220273; tayyabmasood428@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: August 15, 2026
• First Posted: September 15, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)