Dexamethasone Intravenous Versus Intrathecal in Spinal Anesthesia

NCT05470530 | Completed Phase 1

• 1 other identifier: FMASU MS 179/2022
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the the effect of intravenous and the intrathecal dexamethasone when added to spinal anesthesia in cesarean section.

Conditions

Healthy

Keywords

Dexamethasone, spinal anesthesia, cesarean section

Outcome Measures

Primary Outcomes (1)

• Duration of sensory block in spinal anesthesia

  The primary objective of this study is to compare the efficacy of intrathecal dexamethasone with dexamethasone when used intravenously as an adjuvant to prolong the sensory block obtained by spinal anaesthesia and postoperative analgesia in cesarean section

  4 months after starting the study

Study Arms (2)

IT group

ACTIVE COMPARATOR

Participants were received normal saline 2 mL intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL (10mg) plus 0.5 mL (2mg) dexamethasone diluted in 0.5 ml of 0.9% saline, overall 3 ml volume intrathecally. The dose of 2mg of dexamethasone was demonstrated by Amer (2018) to be the least effective intrathecal dose.

Drug: Dexamethasone

IV group

ACTIVE COMPARATOR

Participants were received dexamethasone 2 mL (8mg) intravenously with intrathecal injection of heavy bupivacaine 0.5% 2 mL plus 1 mL of 0.9% saline

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Dexamethasone was given either intrathecal or intravenous in spinal anesthesia during ceaseran section while normal saline was given in control group

IT group; IV group

Eligibility Criteria

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

You may qualify if:

• Female patients in childbearing period with an age of 18 years up to 40 years old scheduled to undergo elective cesarean section under spinal anesthesia.
• All patients were of ASA II physical status with uncomplicated pregnancy and no comorbidity.

You may not qualify if:

• Refusal of procedure or participation in the study by patients. Emergency cesarean section. Any contraindication to spinal anesthesia as infection at site of injection or history or evidence of coagulopathy.
• Congenital anomaly of the spine. Psychiatric illness affecting the ability to properly communicate with the patient or to use the VAS for pain.
• Receiving analgesics or corticosteroid drugs. Allergies to drugs used.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Marwa M Mohamed, Lecturer

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: March 10, 2022
• Primary Completion: July 10, 2022
• Study Completion: July 15, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)