IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

Intramuscular Neostigmine for Accelerating Bladder Emptying After Cesarean Section 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

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: Neostigmine; Drug: NaCl 0.9%

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohamed S Abdelhafez, MD; Phone Number: +201144523366; Email: msabdelhafez@gmail.com

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35111
      • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neostigmine group; After cesarean delivery, women will receive 0.5 mg IM neostigmine	Drug: Neostigmine; Participants will receive 0.5 mg IM neostigmine; Other Names: Epistigmin
Placebo Comparator: Placebo group; After cesarean delivery, women will receive IM NaCl 0.9% as a placebo	Drug: NaCl 0.9%; Participants will receive IM NaCl 0.9% as a placebo; Other Names: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first voiding after treatment	Time interval between IM injection of neostigmine or NaCl and occurrence of first voiding	Until 12 hours postoperatively
Time to first voiding after catheter removal	Time interval between catheter removal and occurrence of first voiding	Until 12 hours postoperatively

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mohamed S Abdelhafez, MD, Mansoura University; Study Director: Nermeen M Shams-Eldien, MD, Mansoura University; Principal Investigator: Aml M Aljaml, Mansoura University; Study Director: Mohamed A Elnegery, MD, Mansoura University; Study Director: Khalid Samir, MD, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Actual): October 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Cesarean Section; Postoperative urine retention (POUR)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: MS.19.12.937.R1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After publication and forever
• IPD Sharing Access Criteria: Contact to corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No