NCT05969119

Brief Summary

Postdural puncture headache (PDPH) is a major complication of neuraxial anesthesia that can occur following spinal anesthesia and with inadvertent Dural puncture during epidural anesthesia. The presence of Pyridostigmine in CSF would be expected to increase the level of acetylcholine in CSF and subsequently in the brain through inhibition of cholinesterase. The increased level of acetylcholine would produce cerebral vasoconstriction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

June 28, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2024

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

June 28, 2023

Last Update Submit

August 30, 2024

Conditions

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (7)

  • The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) where 10 refers to the worst pain at 0 hours.

    15 minutes after sitting upright

  • The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 6 hours.

    6 hours

  • The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 12 hours.

    12 hours

  • The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 24 hours.

    24 hours

  • The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 36 hours.

    36 hours

  • The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 48 hours.

    48 hours

  • The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.

    Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 72hours.

    72 hours

Secondary Outcomes (15)

  • The need for an Epidural blood patch in the Pyridostigmine and control groups.

    72 hours

  • Appearance of neck stiffness in the Pyridostigmine and control groups.

    Before giving the Pyridostigmine or the Placebo

  • Appearance of neck stiffness in the Pyridostigmine and control groups.

    6 hours after the intervention

  • Appearance of neck stiffness in the Pyridostigmine and control groups.

    12 hours after the intervention

  • Appearance of neck stiffness in the Pyridostigmine and control groups.

    24 hours after the intervention

  • +10 more secondary outcomes

Study Arms (2)

Pyridostigmine

EXPERIMENTAL

Parturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours.

Drug: Pyridostigmine

Placebo

PLACEBO COMPARATOR

Parturients with postoperative PDPH and a VAS score of ≥5 will receive placebo tablets similar in shape to pyridostigmine tablets every 6 hours.

Drug: Placebo

Interventions

PyridostigmineDRUG

Parturients with postoperative Postdural puncture headache and a Visual analogue scale (VAS score) of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours or Placebo tablets similar in shape to pyridostigmine tablets every 6 hours.

Pyridostigmine
PlaceboDRUG

Parturients with postoperative Postdural puncture headache and a Visual analogue scale (VAS score) of ≥5 will receive Placebo tablets similar in shape to pyridostigmine tablets every 6 hours.

Placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients American Society of anesthesiologists' physical status (ASA) II because of pregnancy.
  • Patients diagnosed with Postdural puncture headache following intrathecal spinal anesthesia for elective caesarean delivery.

You may not qualify if:

  • Patients with PDPH and a visual analog scale (VAS) score \<5.
  • Patients with history of chronic headache, cluster headache, migraine, convulsions.
  • Patients with history of cerebrovascular accident, previous neurological diseases.
  • Patients with preeclampsia, eclampsia, coagulopathy.
  • Patients with severe bleeding (\>20% of blood volume).
  • Patients undergoing treatment with vasopressors.
  • Patients with bronchial asthma.
  • Patients with arrhythmia, and any type of heart block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez General Hospital

Suez, Egypt

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Pyridostigmine Bromide

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Pyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia intensive care and pain management

Study Record Dates

First Submitted

June 28, 2023

First Posted

August 1, 2023

Study Start

July 25, 2023

Primary Completion

January 3, 2024

Study Completion

January 3, 2024

Last Updated

September 4, 2024

Record last verified: 2024-08

Locations

EG(1)