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UnknownNCT03887949

Comparison of Three Modes of Ventilation During Robot-assisted Hysterectomy in Trendelenburg Position

Comparison of Three Modes of Ventilation During Robot-assisted Hysterectomy in Trendelenburg Position: Volume Controlled Ventilation, Pressure Controlled Ventilation, and Pressure Controlled Ventilation With Volume Guarantee.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Hallym University Medical Center · Academic / Other
Sex
Female
Age
20 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Robot-assisted hysterectomy is associated with pneumoperioneum with CO2 and Trendelenburg position, which may have adverse cardiopulmonary effects. A new ventilation mode; pressure-controlled ventilation with volume guaranteed mode (PCV-VG) delivers constant tidal volume with constant inspiratory pressure, using a decelerating flow pattern. This prospective, randomized study is designed to compare the effects of PCV-VG, volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) on respiratory and hemodynamic variables in patients undergoing Robot-assisted hysterectomy.

Detailed description

1. Total 60 patients with American Society of Anesthesiologists physical status I-II who underwent Robot-assisted hysterectomy were enrolled. 2. All patients were fasted for 8 hours before the surgery and were premedicated with intramuscular glycopyrrolate 0.2 mg. Anesthesia was induced with intravenous remifentanil (0.1-0.2 ug/kg/min), propofol (1.5-2 mg/kg) and rocuronium (0.6 mg/kg) and maintained with sevoflurane (2.0-2.5 vol%) in inspired oxygen fraction with 0.5, remifentanil (0.05-0.3 ug/kg/min) and vecuronium (0.03-0.05 mg/kg/hr). 3. A 20 G catheter was inserted into the radial artery to monitor continuous arterial pressure and hemodynamic variables (cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) monitoring. 4. All patients were ventilated with a Datex-Ohmeda Ventilator (S/5 AVANCE). Patients were randomized to receive VCV (n=20), PCV (n=20), or PCV-VG (n=20) mode. The tidal volume was set to deliver 8 mL/kg of ideal body weight. The respiratory rate(RR) was adjust to maintain end tidal CO2 (ETCO2) 32-37 mmHg. 5. Hemodynamic variables (mean blood pressure, heart rate, cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) , respiratory variables (saturation, RR, ETCO2, peak airway pressure, mean airway pressure and lung dynamic compliance) and arterial gas analyses were recorded at 4 stages: (1) 15 minutes after induction in supine position, (2) 30 minutes after pneumoperitoneum and Trendelenburg position, (3) 60 minutes after pneumoperitoneum and Trendelenburg position, (4) 15 minutes after pneumoperitoneum withdrawal in supine position.

Conditions

Interventions

TypeNameDescription
DEVICEGroup VCVVolume controlled ventilation
DEVICEGroup PCVPressure controlled ventilation
DEVICEGroup PCV-VGPressure controlled ventilation with volume guarantee

Timeline

Start date
2018-05-01
Primary completion
2019-04-30
Completion
2019-05-31
First posted
2019-03-25
Last updated
2019-03-25

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03887949. Inclusion in this directory is not an endorsement.