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

ConditionPost-Dural Puncture Headache
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI less than 35 kg/m2

Scheduled for infraumbilical surgeries

American Society of Anesthesiologists (ASA) physical status: I and II

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

330 Participants
are divided into 3 treatment groups
Group A: Group CPlacebo comparator 1 intervention
Group B: Group NActive comparator 1 intervention
Group C: Group KActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

postdural puncture headache

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

Time frame
1 week

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: