NCT04905953

Brief Summary

We hypothesized that; intrathecal administration of neostgmine in spinal anesthesia may have a beneficial role in reduction of the incidence or severity of PDPH.

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
274

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

March 16, 2021

Last Update Submit

May 24, 2021

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

  • The incidence of PDPH following spinal anesthesia for cesarean section surgery.

    Diagnosis of PDPH is as follows, it is severe and described as "searing and spreading like hot metal," involving the back and front of the head, and spreading to the neck and shoulders, sometimes involving neck stiffness.

    72 hours.

Interventions

NeostigmineDRUG

Intrathecal injection of two doses of neostigmine (10 \& 20 mic) during spinal anesthesia for cesarean section.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales candidate for elective cesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients indicated for elective caesarean section surgery

You may not qualify if:

  • Contraindications for regional anesthesia including local infection, hemorrhagic disorders, drug hypersensitivity, muscular disorders and central and peripheral neuropathy, and drug abuse history and addiction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine- Cairo University

Cairo, 11562, Egypt

RECRUITING

Related Publications (1)

  • Abdelaal Ahmed Mahmoud A, Mansour AZ, Yassin HM, Hussein HA, Kamal AM, Elayashy M, Elemady MF, Elkady HW, Mahmoud HE, Cusack B, Hosny H, Abdelhaq M. Addition of Neostigmine and Atropine to Conventional Management of Postdural Puncture Headache: A Randomized Controlled Trial. Anesth Analg. 2018 Dec;127(6):1434-1439. doi: 10.1213/ANE.0000000000003734.

    PMID: 30169405BACKGROUND

MeSH Terms

Conditions

Headache

Interventions

Neostigmine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Central Study Contacts

Shymaa Fathy, MD

CONTACT

+201000455897angel6122003@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and SICU

Study Record Dates

First Submitted

March 16, 2021

First Posted

May 28, 2021

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

May 1, 2022

Last Updated

May 28, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)