Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04629573 |
| Other study ID # |
IRB0000871248 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2014 |
| Est. completion date |
September 2019 |
Study information
| Verified date |
November 2020 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a prospective study for abdominal myomectomies performed from June 2012 to June 2019
by a single surgeon in a tertiary care referral hospital. Large uterine myoma was defined as
the estimated diameter of dominant myoma equal to or larger than 10 cm by sonography.
Demographics, diagnosis, perioperative variables, operative outcomes and complications were
recorded. The Intraoperative anesthetic management, blood and blood products transfusion, and
total volume of blood loss, as well as postoperative follow-up, were reviewed for each
patient.
Description:
Randomization and Blinding: To allow randomization, researchers prepared the management
protocol for each group and sealed one protocol per envelope with a computer-generated number
assigned prior to study initiation. Randomization was performed by picking the numbered study
envelopes sequentially and opened before induction of anesthesia by the anesthesia doctor and
managing the participant based on the enclosed protocol. The study will not be
double-blinded, as it is impossible to blind the health care workers and women involved for
the strategy to which the woman is allocated.
Interventions Anesthesia technique: On arrival to the operative theatre, an 18 gauge IV
catheter was inserted and 500 ml of NaCl (0.9%) was infused, 1 mg midazolam was administered
iv as premedication. Patients were monitored with continuous electrocardiography and pulse
oximetry and intermittent non-invasive blood pressure measurements every 5 min.
Lumbar epidural: Epidural procedure was performed by attending anesthesiologists who had
completed at least 50 epidural procedures during their training. Patient was placed in the
sitting position, the skin over the lumbar area was cleaned and a sterile technique was
observed throughout the procedure. Skin and subcutaneous tissue were infiltrated with 1%
lidocaine 2 mL at the intended site of epidural placement (L2-3 or L3-4 interspace). The
lumbar epidural space was then located, using a midline approach with an 18 gauge Tuohy
epidural needle via a loss of resistance technique with 2 mL of saline, 20 gauge epidural
catheter was placed in each patient. We deliver an initial bolus of 20 ml bupivacaine 0.5%
plus 100 mcg Fentanyl, followed by continuous infusion of bupivacaine 0.5% plus 1mcg/ml
Fentanyl (3-5 ml/hr.).
General anesthesia: Anesthesia was initiated with IV fentanyl 1 µg/kg, propofol 2 mg/kg and
cisatracurium 0.15 mg/kg to facilitate endotracheal intubation. After tracheal intubation,
anesthesia was maintained with sevoflurane in O2 and air (FiO2 of 0.5), cisatracurium
1µg/kg/min and fentanyl 0.5 µg/ kg /h were infused. Volume-Controlled ventilation was
performed in all patients. Cisatracurium and fentanyl infusion was stopped at the end of
surgery, neuromuscular blockade was reversed, and the patient was extubated and send to
post-anesthesia care unit.
Myomectomy: Abdominal myomectomy was performed in the standard conventional fashion. A single
surgeon handled all the surgical procedures. The myomectomy was performed by enucleating the
fibroid and closing the uterine defect in multiple layers. The use of energy devices, suture
type, and adhesion barriers were at the discretion of the surgeon.
