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

Last updated: July 14, 2024
Sponsor: Minia University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Pain (Pediatric)

Chronic Pain

Pain

Treatment

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.

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

Clinical Study ID

NCT06493838
0379/2023
  • Ages 18-35
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Parturient ladies

  • Age ranges from 18 to 35 years old.

  • ASA II with elective caesarean section under sub-arachnoid block

Exclusion

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 persistentcephalgia, convulsions, cerebrovascular events

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: 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.
Phase: 4
Study Start date:
July 15, 2024
Estimated Completion Date:
January 16, 2025