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

NCT ID: NCT06729047

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-11-05

Brief Summary

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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

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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

Conditions

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Post-Dural Puncture Headache

Keywords

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Neostigmine ketorolac

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group C

patients will receive placebo (normal saline)

Group Type PLACEBO_COMPARATOR

normal Saline

Intervention Type DRUG

patients will receive placebo (normal saline)

Group N

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

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

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

Group K

patients will receive ketorolac (0.5 mg/kg)

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

patients will receive ketorolac (0.5 mg/kg)

Interventions

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normal Saline

patients will receive placebo (normal saline)

Intervention Type DRUG

Neostigmine

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

Intervention Type DRUG

Ketorolac

patients will receive ketorolac (0.5 mg/kg)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine, Assiut University, Assiut, Egypt,

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ghada Abo Elfadl, MD

Role: CONTACT

Phone: 01005802086

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 33725180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32223975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37434934 (View on PubMed)

Other Identifiers

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04-2024-200988

Identifier Type: -

Identifier Source: org_study_id