IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

Phase 4

Completed

• Conditions: Cesarean Section Complications
• Interventions: Drug: NaCl 0.9%; Drug: Neostigmine

• Registration Number: NCT04364607
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-28
• Study Start: 2020-08-05
• Primary Completion: 2021-10-26
• Study Completion: 2021-10-26
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	NaCl 0.9%	After cesarean delivery, women will receive IM NaCl 0.9% as a placebo
Neostigmine group	Neostigmine	After cesarean delivery, women will receive 0.5 mg IM neostigmine

Primary Outcome Measures

Name	Time	Method
Time to first voiding after treatment	Until 12 hours postoperatively	Time interval between IM injection of neostigmine or NaCl and occurrence of first voiding
Time to first voiding after catheter removal	Until 12 hours postoperatively	Time interval between catheter removal and occurrence of first voiding

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt