Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: normal Saline, Neostigmine, Ketorolac.
- Who it may be relevant to
- Registry conditions: Post-Dural Puncture Headache. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries: A Randomized Clinical Trial
Overview
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
Detailed description
The usual symptoms of PDPH other than headache are photophobia, neck stiffness, nausea and vomiting, diplopia, tinnitus, and dizziness. The headache is usually throbbing and severe, starting from the forehead and extending to the occiput, and is aggravated by standing or sitting. This is due to meningeal traction associated with cerebrospinal fluid (CSF) pressure reduction or dilation of cerebral arteries as an indirect effect of lowering CSF pressure as a result of CSF leakage from the punctured dura. Current treatments or preventive measures for PDPH other than bed rest and hydration include theophylline, sumatriptan, caffeine, etc. In resistant or severe cases, epidural blood patch (EBP) is a well-described technique used to provide relief of pain.
The co-administration of neostigmine and atropine is a common treatment for terminating the effects of non-depolarizing muscle relaxants in the setting of general anesthesia with minimal side
Interventions
- Drug normal Saline
patients will receive placebo (normal saline) - Drug Neostigmine
patients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg) - Drug Ketorolac
patients will receive ketorolac (0.5 mg/kg)
Primary outcome measures
- postdural puncture headache [Time frame: 1 week]
Eligibility criteria
Inclusion criteria
- BMI less than 35 kg/m2
- Scheduled for infraumbilical surgeries
- American Society of Anesthesiologists (ASA) physical status: I and II
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Faculty of medicine, Assiut University, Assiut, Egypt, — Asyut
Publications
- 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 33725180
- Ljubisavljevic 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 32223975
- Ahmadzade 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 37434934
Identifiers
NCT: NCT06729047 · 04-2024-200988