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

Phase 1

Not yet recruiting

• Conditions: Post-Dural Puncture Headache
• Interventions: Drug: normal Saline; Drug: Neostigmine; Drug: Ketorolac

• Registration Number: NCT06729047
• Lead Sponsor: Assiut University

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

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-08
• Last Update Submitted: 2024-12-08
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Study Start: 2024-12-15
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	normal Saline	patients will receive placebo (normal saline)
Group N	Neostigmine	patients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg)
Group K	Ketorolac	patients will receive ketorolac (0.5 mg/kg)

Primary Outcome Measures

Name	Time	Method
postdural puncture headache	1 week	the incidence of occurrence of PDPH in patients undergoing infraumbilical surgeries under SA.

Trial Locations

Locations (1)

Faculty of medicine, Assiut University, Assiut, Egypt,; 🇪🇬 Assiut, Egypt