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NCT Number: NCT06729047

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Faculty of medicine, Assiut University, Assiut, Egypt,

Asyut, 71515, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

patients will receive placebo (normal saline)

Neostigmine

Drug

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

Ketorolac

Drug

patients will receive ketorolac (0.5 mg/kg)

Primary outcomes

  1. postdural puncture headache

    Time frame: 1 week

    the incidence of occurrence of PDPH in patients undergoing infraumbilical surgeries under SA.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada Abo Elfadl, MD

CONTACT

[email protected]

01005802086

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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