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IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

M

Mansoura University

Status and phase

Completed
Phase 4

Conditions

Cesarean Section Complications

Treatments

Drug: Neostigmine
Drug: NaCl 0.9%

Study type

Interventional

Funder types

Other

Identifiers

NCT04364607
MS.19.12.937.R1

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

Female

Ages

20 to 35 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Neostigmine group
Active Comparator group
Description:
After cesarean delivery, women will receive 0.5 mg IM neostigmine
Treatment:
Drug: Neostigmine
Placebo group
Placebo Comparator group
Description:
After cesarean delivery, women will receive IM NaCl 0.9% as a placebo
Treatment:
Drug: NaCl 0.9%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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