Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 1, 2017

Primary Completion Date

March 31, 2019

Study Completion Date

March 31, 2019

Conditions
AnesthesiaSurgery--Complications
Interventions
DRUG

Intravenous anesthetic

Anaesthesia induction will be obtained with i.v. 2-3 mg/kg propofol, 0,6-0,8 mcg/kg fentanyl, and 0.9-1,2 mg/kg rocuronium. Anaesthesia will be maintained with i.v. propofol continuous infusion, with a dose titrated to achieve a bi-spectral index value between 40 and 50

DRUG

Crystalloid Solutions

Balanced crystalloids will be administered to patients in both groups as a standard rate of 3-5 ml/kg/h. Treatment of eventual hemodynamic instability will be left to the attending physician

DIAGNOSTIC_TEST

Esophageal pressure measurement

A nasogastric polyfunctional tube (Nutrivent, Sidam, Italy) will be placed after anaesthesia induction in all enrolled patients to measure esophageal pressure, estimate pleural pressure and compute transpulmonary pressure

DIAGNOSTIC_TEST

Lung volume measurement with the nitrogen washin-washout technique

Lung volume will be measured through nitrogen wash-in wash-out technique and low-flow Pressure-volume curve will be recorded to estimate differences in alveolar recruitment between the two study groups.

Trial Locations (1)

00100

General surgery OR, A. Gemelli hospital, Rome

All Listed Sponsors
lead

Catholic University of the Sacred Heart

OTHER

NCT03157479 - Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery | Biotech Hunter | Biotech Hunter