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

NCT ID: NCT06493838

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-01-16

Brief Summary

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

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DRUG

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

Neostgmine 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.

Group Type: 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.

Intervention Type: 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.

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

Intervention Type: 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.

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Mina Maher

Ass professor anesthesia and pain

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

0379/2023

Identifier Type: -

Identifier Source: org_study_id