Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Postdural Puncture Headache

Treatments: Drug: Placebo; Drug: Pyridostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT05969119

SUEZ Med-IRB 1/2023

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Pyridostigmine

Experimental group

Description:

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

Treatment:

Drug: Pyridostigmine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo