Clinical trial NCT06729047: Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Post-Dural Puncture Headache
Keywords: Neostigmine
ketorolac
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

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:

1. ASA physical status more than II.
2. History of allrgic response to local anaesthetics or any of the medications used in the study
3. Patients with cognitive impairment
4. pregnancy
5. Basal body temperature of more than 38°C or less than 36°C
6. BMI more than 35 kg/m2

Primary outcomes:
measure: postdural puncture headache
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine, Assiut University, Assiut, Egypt,
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.