Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

NCT ID: NCT05969119

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2024-01-03

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.

Conditions

Postdural Puncture Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pyridostigmine

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

Group Type: EXPERIMENTAL

Pyridostigmine

Intervention Type: DRUG

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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Pyridostigmine

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

riham fathy galal

Lecturer of Anesthesia intensive care and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Suez General Hospital

Suez, , Egypt

Countries

Egypt

Other Identifiers

SUEZ Med-IRB 1/2023

Identifier Type: -

Identifier Source: org_study_id