Clinical trial

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

Name
MS.19.12.937.R1
Description
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
Trial arms
Trial start
2020-08-05
Estimated PCD
2021-10-26
Trial end
2021-10-26
Status
Completed
Phase
Early phase I
Treatment
Neostigmine
Participants will receive 0.5 mg IM neostigmine
Arms:
Neostigmine group
Other names:
Epistigmin
NaCl 0.9%
Participants will receive IM NaCl 0.9% as a placebo
Arms:
Placebo group
Other names:
Normal Saline
Size
100
Primary endpoint
Time to first voiding after treatment
Until 12 hours postoperatively
Time to first voiding after catheter removal
Until 12 hours postoperatively
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-06-07

1 organization

1 product

1 drug

1 indication