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

Minia University

Status and phase: Not yet enrolling; Phase 4

Conditions: Acute Pain

Treatments: Drug: intravenous 50 mL of saline injection of 0.9% after 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT06493838

0379/2023

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

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

Neostgmine group

Active Comparator group

Description:

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.

Treatment:

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.