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Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries

Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries: A Randomized Clinical Trial

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06729047
Enrollment
330
Registered
2024-12-11
Start date
2024-12-15
Completion date
2025-11-05
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Dural Puncture Headache

Keywords

Neostigmine, ketorolac

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

Interventions

DRUGnormal Saline

patients will receive placebo (normal saline)

DRUGNeostigmine

patients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg)

DRUGKetorolac

patients will receive ketorolac (0.5 mg/kg)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postdural puncture headache1 weekthe incidence of occurrence of PDPH in patients undergoing infraumbilical surgeries under SA.

Countries

Egypt

Contacts

Primary ContactGhada Abo Elfadl, MD
ghadafadl77@gmail.com01005802086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026