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Anticholinergic

Neostigmine + Atropine for Post-Dural Puncture Headache

Phase 2
Recruiting
Led By Mark Rollins, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention
Awards & highlights

Study Summary

This trial is testing if neostigmine + atropine is better than usual care at reducing the number of postpartum women with a PDPH who need an EBP after an accidental dural puncture.

Who is the study for?
This trial is for postpartum women who developed a headache within 72 hours after delivery, specifically due to an accidental dural puncture during epidural analgesia. It's not suitable for those with asthma, heart issues like block or arrhythmias, inability to understand pain scores or speak English, fever over 38.5 C, refusal to participate, contraindications to certain pain relievers, history of migraines or myasthenia gravis.Check my eligibility
What is being tested?
The study tests Neostigmine and Glycopyrrolate as treatments for headaches following dural puncture in new mothers. The goal is to see if these drugs can reduce the need for an epidural blood patch in women who got headaches after the needle used during labor caused a puncture.See study design
What are the potential side effects?
Potential side effects may include dry mouth from Glycopyrrolate and muscle cramps or twitching from Neostigmine. Both drugs could cause changes in heart rate and vision disturbances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 hour, 8 hours, 16 hours, 24 hours, 48 hours, 1 week, and 2 weeks after intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of postpartum women requiring epidural blood patch
Secondary outcome measures
Adverse Events
Change in pain scores

Trial Design

1Treatment groups
Experimental Treatment
Group I: Postpartum dural puncture headache following dural puncture from Tuohy needleExperimental Treatment2 Interventions
Subjects identified as experienced a post dural puncture headache after a confirmed dural puncture from a Tuohy needle will receive an IV administration of the study medications neostigmine and glycopyrrolate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glycopyrrolate
2011
Completed Phase 4
~23980
Neostigmine
2020
Completed Phase 4
~2070

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,767,020 Total Patients Enrolled
1 Trials studying Post-Dural Puncture Headache
Mark Rollins, MD, PhDPrincipal InvestigatorMayo Clinic

Media Library

Atropine (Anticholinergic) Clinical Trial Eligibility Overview. Trial Name: NCT05116930 — Phase 2
Post-Dural Puncture Headache Research Study Groups: Postpartum dural puncture headache following dural puncture from Tuohy needle
Post-Dural Puncture Headache Clinical Trial 2023: Atropine Highlights & Side Effects. Trial Name: NCT05116930 — Phase 2
Atropine (Anticholinergic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05116930 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what clinical purposes is Neostigmine typically administered?

"Neostigmine has been found to be efficacious in managing ureteric colic, laughing episodes, and changes in pupil size."

Answered by AI

What other research has examined the efficacy of Neostigmine?

"Currently, there are 32 Neostigmine clinical trials taking place around the world. Of these live studies, 7 have reached Phase 3 status. Most of the sites investigating this medication are located in San Antonio but many other locations across 157 cities are also conducting research on it."

Answered by AI

Is participation in this research study open to individuals aged 60 and over?

"The requirements to take part in this study state that the age of participants should be within 18 and 54."

Answered by AI

Is there still an opportunity for participants to join this research endeavor?

"Affirmative. Per the information stored on clinicaltrials.gov, this study is actively seeking patients for recruitment; it was initially posted on November 19th 2021 and last updated December 1st 2021. 18 participants are needed from a single medical centre to participate in the trial."

Answered by AI

What is the participant count of this research project?

"Affirmative. According to the data provided by clinicaltrials.gov, this trial is actively seeking participants; it was first published on November 19th 2021 and most recently updated on December 1st 2021. The researchers are looking for 18 recruits from a single site."

Answered by AI

Has Neostigmine been granted permission by the FDA for use?

"Our team at Power gave Neostigmine a rating of 2 on the safety scale, as it is in Phase 2 and has evidence supporting its security but no proof backing up its effectiveness."

Answered by AI

Is there a specific demographic that can partake in this scientific research?

"The requirements for this clinical trial dictates that candidates should be aged between 18 and 54, have post-dural puncture headache, and must agree to participate in the study. A total of 18 participants are needed."

Answered by AI
~3 spots leftby Dec 2024