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Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.

NCT05289323 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 722

Last updated 2023-07-27

No results posted yet for this study

Summary

Intravenous neostigmine was recently reported as an effective treatment for PDPH for parturients after intrathecal (IT) block which is postulated to be through its central effects on CSF secretion and cerebral vascular tone modulation. Intrathecal neostigmine has been investigated widely and found to be an effective adjuvant to bupivacaine for postoperative analgesia.

The objective of the current study is to investigate the possible prophylactic role of intrathecal neostigmine as an adjuvant to bupivacaine in reducing the incidence and severity of post-dural puncture headache in parturients scheduled for an elective cesarean section.

Conditions

  • Post-Dural Puncture Headache

Interventions

DRUG

Neostigmine Methylsulfate

0.5 mg ampule (1 ml) will be diluted in 4 ml dextrose 5% to make a solution of 100 μg/ml, 0.2 ml of this solution will be added to 2.5 ml of hyperbaric bupivacaine 0.5 % used for intrathecal injection.

DRUG

Dextrose 5%/Nacl 0.9% Inj

one ml of normal saline 0.9 % will be mixed with 4 ml dextrose 5 % in the five-milliliter syringe. 0.2 ml of this mixture will be prepared at a one-milliliter identical syringe.

Sponsors & Collaborators

  • Kasr El Aini Hospital

    collaborator OTHER

  • Fayoum University

    collaborator OTHER

  • Alexandria University

    lead OTHER

Principal Investigators

  • Hisham M Gamal Eldine, MD · University of Alexandria

  • Ahmed I Elnaggar, MD · University of Alexandria

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2023-07-25
Completion
2023-07-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05289323 on ClinicalTrials.gov