IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

NCT04364607 | Completed Phase 4

• 1 other identifier: MS.19.12.937.R1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Cesarean Section Complications

Keywords

Cesarean Section; Spinal anesthesia; Postoperative urine retention (POUR)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Neostigmine group

ACTIVE COMPARATOR

After cesarean delivery, women will receive 0.5 mg IM neostigmine

Drug: Neostigmine

Placebo group

PLACEBO COMPARATOR

After cesarean delivery, women will receive IM NaCl 0.9% as a placebo

Drug: NaCl 0.9%

Interventions

Neostigmine DRUG

Participants will receive 0.5 mg IM neostigmine

Also known as: Epistigmin

Neostigmine group

NaCl 0.9% DRUG

Participants will receive IM NaCl 0.9% as a placebo

Also known as: Normal Saline

Placebo group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women undergoing elective cesarean deliver under spinal anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

MeSH Terms

Interventions

Neostigmine; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Aml M Aljaml

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Mohamed A Elnegery, MD

  Mansoura University

  STUDY DIRECTOR

• Nermeen M Shams-Eldien, MD

  Mansoura University

  STUDY DIRECTOR

• Khalid Samir, MD

  Mansoura University

  STUDY DIRECTOR

• Mohamed S Abdelhafez, MD

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: August 5, 2020
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication and forever
• Access Criteria: Contact to corresponding author

Locations

EG (1)