Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

Postdural Puncture Headache Clinical Trial

Official title:

Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05969119
• Other study ID #: SUEZ Med-IRB 1/2023
• Status: Completed
• Phase: Phase 4
• Start date: July 25, 2023
• Est. completion date: January 3, 2024

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 3, 2024
• Est. primary completion date: January 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Suez General Hospital	Suez

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	The need for an Epidural blood patch in the Pyridostigmine and control groups.	An EBP will be performed during the study if the VAS(Visual analogue scale) will be =5 after 72 hours from intervention start following parturient approval and consent, or if requested by the parturient at any time during the study.	72 hours
Secondary	Appearance of neck stiffness in the Pyridostigmine and control groups.	Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.	Before giving the Pyridostigmine or the Placebo
Secondary	Appearance of neck stiffness in the Pyridostigmine and control groups.	Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.	6 hours after the intervention
Secondary	Appearance of neck stiffness in the Pyridostigmine and control groups.	Appearance of neck stiffness in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.	12 hours after the intervention
Secondary	Appearance of neck stiffness in the Pyridostigmine and control groups.	Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.	24 hours after the intervention
Secondary	Appearance of neck stiffness in the Pyridostigmine and control groups.	Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.	36 hours after the intervention
Secondary	Appearance of neck stiffness in the Pyridostigmine and control groups.	Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.	48 hours after the intervention
Secondary	Appearance of neck stiffness in the Pyridostigmine and control groups.	Appearance of neck stiffness in the Pyridostigmine and control groups and will be recorded after asking the patients by yes or no.	72 hours after the intervention
Secondary	Appearance of Nausea and vomiting in the Pyridostigmine and control groups.	Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.	Before giving the Pyridostigmine or the Placebo
Secondary	Appearance of Nausea and vomiting in the Pyridostigmine and control groups.	Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.	6 hours after the intervention
Secondary	Appearance of Nausea and vomiting in the Pyridostigmine and control groups.	Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.	12 hours after the intervention
Secondary	Appearance of Nausea and vomiting in the Pyridostigmine and control groups.	Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.	24 hours after the intervention
Secondary	Appearance of Nausea and vomiting in the Pyridostigmine and control groups.	Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.	36 hours after the intervention
Secondary	Appearance of Nausea and vomiting in the Pyridostigmine and control groups.	Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.	48 hours after the intervention
Secondary	Appearance of Nausea and vomiting in the Pyridostigmine and control groups.	Appearance of Nausea and vomiting in the Pyridostigmine and control groups that will be recorded after asking the patients by yes or no.	72 hours after the intervention