IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04364607

Enrollment

100

Registered

2020-04-28

Start date

2020-08-05

Completion date

2021-10-26

Last updated

2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

Keywords

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

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.

Interventions

DRUGNeostigmine

Participants will receive 0.5 mg IM neostigmine

DRUGNaCl 0.9%

Participants will receive IM NaCl 0.9% as a placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026