Clinical Efficacy of Prophylactic Intravenous Neostigmine and Atropine in Preventing Post-Dural Puncture Headache Among Parturient Undergoing Spinal Anesthesia for Cesarean Section: A Double-blind Randomized Placebo-controlled Trial

NCT06493838 | Not Yet Recruiting Phase 4

• 1 other identifier: 0379/2023
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of patients with post dural puncture headache

  Number of patients develop post dural puncture headache

  first 5 days post-partum

Secondary Outcomes (6)

• Severity of post dural puncture headache

  first 5 days post-partum

• onset and duration of post dural puncture headache

  5 days post partum

• Analgesic request

  24 hours after operation

• Analgesc requirements

  2 days after operation

• frequency of analgesic doses

  5 days

Study Arms (2)

Control group

PLACEBO COMPARATOR

intravenous 50 mL of sterile saline 0.9% injection of 0.9% after umbilical cord clamping.

Drug: intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.

Neostgmine group

ACTIVE COMPARATOR

Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.

Drug: Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.

Interventions

intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping. DRUG

intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.

Control group

Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping. DRUG

Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.

Neostgmine group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: We target obstetric population
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Parturient ladies
• Age ranges from 18 to 35 years old.
• ASA II with elective caesarean section under sub-arachnoid block

You may not qualify if:

• BMI \>35
• Refusal to participate
• surgical complications necessitating a blood transfusion
• Emergency caesarean section
• the need for endotracheal intubation or vasopressors
• any contraindication to regional anesthesia (such as a history of persistent cephalgia, convulsions, cerebrovascular events

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Acute Pain

Interventions

Neostigmine; Atropine; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass professor anesthesia and pain

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 10, 2024
• Study Start: July 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 16, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07