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IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

Sponsor
Mansoura University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04364607
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
14.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effectiveness of intramuscular (IM) 0.5 mg neostigmine for accelerating bladder emptying and preventing postoperative urine retention (POUR) after cesarean section (CS) performed under spinal anesthesia.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Women will be allowed to drink clear fluid up to 200 ml until 2 hours before induction of anesthesia. All women will be asked to urinate before transfer to the operating theatre. On arrival of the patient to operative theatre, intravenous (IV) cannula will be inserted and IV infusion of Ringer's acetate (20 ml/kg) will be given as a fluid preload. All participants will receive the standard intraoperative care and monitoring. After surgery, in the postoperative care unit, participants will receive either 0.5 mg IM neostigmine (study group) or IM NaCl 0.9% (control group).

Urinary bladder ultrasound will be performed hourly until spontaneous micturition occurs. If POUR occurred (inability to void with at a bladder volume > 600 ml detected by ultrasound), then they will be catheterized by closed envelope technique. The prolate ellipsoid method was used to measure urinary bladder volume based on the formula volume = length × width × height × 0.52 on a two-dimensional image. The duration of surgery, the amount of administered intraoperative fluid, and the urinary bladder volume before IM injection will be recorded.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Intramuscular Neostigmine for Accelerating Bladder Emptying After Cesarean Section by Spinal Anesthesia
Anticipated Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Neostigmine group

After surgery, in the postoperative care unit, participants will receive 0.5 mg IM neostigmine

Drug: Neostigmine
Participants will receive 0.5 mg IM neostigmine
Other Names:
  • Epistigmin

    		•
    Placebo Comparator: Placebo group

    After surgery, in the postoperative care unit, participants will receive IM NaCl 0.9% as a placebo

    Drug: NaCl 0.9%
    Participants will receive IM NaCl 0.9% as a placebo
    Other Names:
  • Normal Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to first voiding after IM injection [Until 12 hours postoperatively]

      Time interval between IM injection of neostigmine or NaCl and occurrence of first voiding

    2. Time to first voiding after spinal anesthesia [Until 12 hours postoperatively]

      Time interval between induction of spinal anesthesia and occurrence of first voiding

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pregnant women undergoing elective CS under spinal anesthesia.
    Exclusion Criteria:

    • Age < 20 or > 35 years.

    • Height < 150 or > 180 cm or body mass index (BMI) > 35 kg/m2.

    • Active labor.

    • Multifetal pregnancy.

    • Fetal distress.

    • Placenta previa.

    • Vaginal bleeding or placental abruption.

    • Medical conditions complicating or co-existing with pregnancy such as HELLP syndrome, thrombocytopenia, hepatic or renal impairment, cardiac disease or pulmonary edema or cyanosis.

    • Urinary tract symptoms (frequency incontinence, enuresis. nocturia, hesitancy, urgency, weak stream, dysuria, and inability to empty the bladder fully).

    • Contraindication for central neuraxial block.

    • History of adverse reaction contraindications for Neostigmine.

    • Refusal to undergo regional anesthesia.

    • Surgical duration > 1 hour.

    • Intraoperative significant bleeding (> 10% of blood volume).

    • Any postoperative complications as eclampsia.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mansoura University Hospital Mansoura Dakahlia Egypt 35111

    Sponsors and Collaborators

    • Mansoura University

    Investigators

    • Principal Investigator: Aml Aljaml, Mansoura University
    • Study Director: Nermeen M Shams-Eldien, MD, Mansoura University
    • Study Director: Mohamed S Abdelhafez, MD, Mansoura University
    • Study Chair: Mohamed A Elnegery, MD, Mansoura University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mansoura University
    ClinicalTrials.gov Identifier:
    NCT04364607
    Other Study ID Numbers:
    • MS.19.12.937.R1
    First Posted:
    Apr 28, 2020
    Last Update Posted:
    Apr 28, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mansoura University
    Cesarean Section
    Spinal anesthesia
    Postoperative urine retention (POUR)
    Additional relevant MeSH terms:
    Neostigmine

    Study Results

    No Results Posted as of Apr 28, 2020