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OpenTrials
Completed

NCT Number: NCT04364607

IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

The aim of this study is to assess the efficacy of IM neostigmine (0.5 mg) for acceleration of bladder evacuation and prevention of postoperative urine retention following cesarean delivery carried out under spinal anesthesia

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Key information

Conditions

Cesarean Section Complications

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

About this study

Following cesarean delivery, women will receive either 0.5 mg IM neostigmine (study group) or IM NaCl 0.9% (control group). Bladder ultrasonography will be done every hour until spontaneous voiding occurs. If postoperative urine retention occurred (void inability with bladder volume > 600 ml by ultrasound), urinary catheterization will be done.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women undergoing elective cesarean deliver under spinal anesthesia.

Exclusion criteria

  • The age of the patient is more than 35 years of less than 20 years.
  • The body mass index of the patient is more than 35 kg/m2 or her height is more than 180 cm or less than 150 cm.
  • Multiple gestation.
  • The patient is in active labor.
  • Vaginal bleeding, placenta previa or abruption of the placenta.
  • Presence of fetal distress.
  • Urinary symptoms.
  • Medical disorders co-existing with or complicating pregnancy.
  • Contraindications for or history of adverse reaction of Neostigmine.
  • Contraindication for spinal anesthesia.
  • Refusal of the patient to receive spinal anesthesia.
  • Intraoperative significant hemorrhage.
  • Duration of the operation is more than one hour.
  • Occurrence of postoperative complications as eclampsia.

Treatment and study plan

Neostigmine

Drug

Participants will receive 0.5 mg IM neostigmine

Other names: Epistigmin

NaCl 0.9%

Drug

Participants will receive IM NaCl 0.9% as a placebo

Other names: Normal Saline

Primary outcomes

  1. Time to first voiding after treatment

    Time frame: Until 12 hours postoperatively

    Time interval between IM injection of neostigmine or NaCl and occurrence of first voiding

  2. Time to first voiding after catheter removal

    Time frame: Until 12 hours postoperatively

    Time interval between catheter removal and occurrence of first voiding

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Intramuscular Neostigmine for Accelerating Bladder Emptying After Cesarean Section by Spinal Anesthesia

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2020
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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