Clinical trial NCT05969119: Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache
Official title: Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postdural Puncture Headache
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
timeFrame: 15 minutes after sitting upright
measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
timeFrame: 6 hours
measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
timeFrame: 12 hours
measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
timeFrame: 24 hours
measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
timeFrame: 36 hours
measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
timeFrame: 48 hours
measure: The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
timeFrame: 72 hours
Secondary outcomes:
measure: The need for an Epidural blood patch in the Pyridostigmine and control groups.
timeFrame: 72 hours
measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
timeFrame: Before giving the Pyridostigmine or the Placebo
measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
timeFrame: 6 hours after the intervention
measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
timeFrame: 12 hours after the intervention
measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
timeFrame: 24 hours after the intervention
measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
timeFrame: 36 hours after the intervention
measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
timeFrame: 48 hours after the intervention
measure: Appearance of neck stiffness in the Pyridostigmine and control groups.
timeFrame: 72 hours after the intervention
measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
timeFrame: Before giving the Pyridostigmine or the Placebo
measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
timeFrame: 6 hours after the intervention
measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
timeFrame: 12 hours after the intervention
measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
timeFrame: 24 hours after the intervention
measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
timeFrame: 36 hours after the intervention
measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
timeFrame: 48 hours after the intervention
measure: Appearance of Nausea and vomiting in the Pyridostigmine and control groups.
timeFrame: 72 hours after the intervention
Other outcomes:
Locations:
city: Suez
country: Egypt
facility: Suez General Hospital
Study officials:
References: