Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries
1 other identifier
interventional
330
1 country
1
Brief Summary
Post-dural puncture headache (PDPH) or spinal (or post-spinal) headache is one of the most common side effects of spinal anesthesia, with an incidence of 6-36%. The incidence of this complication was reported to be 76-85% after accidental dural puncture in epidural anesthesia. It usually starts within several hours after spinal anesthesia, but sometimes it can be delayed for up to 2 weeks, which usually resolves within a few days
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2024
1 active site
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
December 8, 2024
CompletedFirst Posted
Study publicly available on registry
December 11, 2024
CompletedStudy Start
First participant enrolled
December 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2025
CompletedDecember 11, 2024
December 1, 2024
11 months
December 8, 2024
December 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postdural puncture headache
the incidence of occurrence of PDPH in patients undergoing infraumbilical surgeries under SA.
1 week
Study Arms (3)
Group C
PLACEBO COMPARATORpatients will receive placebo (normal saline)
Group N
ACTIVE COMPARATORpatients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg)
Group K
ACTIVE COMPARATORpatients will receive ketorolac (0.5 mg/kg)
Interventions
Eligibility Criteria
You may qualify if:
- BMI less than 35 kg/m2
- Scheduled for infraumbilical surgeries
- American Society of Anesthesiologists (ASA) physical status: I and II
You may not qualify if:
- ASA physical status more than II.
- History of allrgic response to local anaesthetics or any of the medications used in the study
- Patients with cognitive impairment
- pregnancy
- Basal body temperature of more than 38°C or less than 36°C
- BMI more than 35 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of medicine, Assiut University, Assiut, Egypt,
Asyut, 71515, Egypt
Related Publications (3)
Kamm K, Forderreuther S. [Post-dural puncture headache]. Schmerz. 2021 Apr;35(2):139-149. doi: 10.1007/s00482-021-00540-x. Epub 2021 Mar 16. German.
PMID: 33725180BACKGROUNDLjubisavljevic S, Zidverc Trajkovic J. Postdural puncture headache leads to clinical worsening of pre-existing chronic headache. J Clin Neurosci. 2020 May;75:30-34. doi: 10.1016/j.jocn.2020.03.043. Epub 2020 Mar 26.
PMID: 32223975BACKGROUNDAhmadzade Z, Golparvar M, Sepiani S. Evaluation of the Preventive Effects of Neostigmine Plus Atropine on Post-Dural Puncture Headache. Adv Biomed Res. 2023 May 15;12:119. doi: 10.4103/abr.abr_81_22. eCollection 2023.
PMID: 37434934BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 8, 2024
First Posted
December 11, 2024
Study Start
December 15, 2024
Primary Completion
November 1, 2025
Study Completion
November 5, 2025
Last Updated
December 11, 2024
Record last verified: 2024-12