IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364607
• Other study ID #: MS.19.12.937.R1
• Status: Completed
• Phase: Phase 4
• Start date: August 5, 2020
• Est. completion date: October 26, 2021

Study information

• Verified date: June 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• Neostigmine
Participants will receive 0.5 mg IM neostigmine
• NaCl 0.9%
Participants will receive IM NaCl 0.9% as a placebo

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first voiding after treatment	Time interval between IM injection of neostigmine or NaCl and occurrence of first voiding	Until 12 hours postoperatively
Primary	Time to first voiding after catheter removal	Time interval between catheter removal and occurrence of first voiding	Until 12 hours postoperatively