NCT06233032

Brief Summary

Could ephedrine replace dexamedetomidine for prevention of shivering in women undergoing Cesarean section Under spinal anaesthesia

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

February 10, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 31, 2024

Status Verified

June 1, 2023

Enrollment Period

1.4 years

First QC Date

September 5, 2023

Last Update Submit

January 22, 2024

Conditions

Prevention of Shivering With Spinal Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Prevention of shivering during spinal anaesthesia in cesarean delivery .Intensity of shivering assessed using five point scale

    one hundred Pts will be included in this study . 1. fifty patients will receive Ephedrine 6 mg IV bolus before spinal block. 2. fifty patients will be receive 30 microgram IV bolus before spinal block

    45min

Study Arms (2)

Group E

EXPERIMENTAL
Drug: Ephedrine

Group D

EXPERIMENTAL
Drug: Dexmedetomidine

Interventions

EphedrineDRUG

Patient Will receive 6mg IV

Group E
DexmedetomidineDRUG

Patient Will receive 30mcg IV

Group D

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult female from 18 to 35 yrs
  • uncomplicated pregnancy for elective cesarean delivery

You may not qualify if:

  • patient refusal
  • allergy to the drug
  • contraindications of spinal anaesthesia
  • patients with DM or thyroid disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

EphedrineDexmedetomidine

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylaminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Dina Salah Kamal, Master

CONTACT

01009196736dina14296@gmail.com

Ola Mahmoud, Professor

CONTACT

01013046017

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 5, 2023

First Posted

January 31, 2024

Study Start

February 10, 2024

Primary Completion

July 1, 2025

Study Completion

September 1, 2025

Last Updated

January 31, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)