Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04802122 |
Other study ID # |
INTUSEVO |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
May 24, 2021 |
Est. completion date |
July 14, 2021 |
Study information
Verified date |
August 2021 |
Source |
Aristotle University Of Thessaloniki |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Airway management is of outmost importance in the perioperative period. One of the main
questions while making a plan for airway management is whether spontaneous ventilation should
be maintained or not. Induction of anesthesia with Sevoflurane is a conventional technique
that preserves spontaneous ventilation. It is used especially in non-collaborating patients
or when other pharmaceutical agents or sophisticated airway management equipment is out of
reach.
Inhalational induction of anesthesia with Sevoflurane is well studied. However, there are few
studies investigating the effects of Sevoflurane on induction and intubating conditions, on
cardiopulmonary physiology, on emergence conditions, when it is used as one and only agent to
achieve induction of anesthesia, intubation and maintenance of anesthesia in adult patients.
There is also no consensus on the appropriate duration of the inhalational induction or other
criteria to guarantee successful intubation conditions, since most studies investigate
Sevoflurane administration until induction of anesthesia and not until intubation.
From all the above, it appears that there are a few gaps in the management of patients who
are to be intubated with Sevoflurane only, without the use of any other anesthetic agents.
Description:
Preoperatively, the study protocol-mandated baseline data will be recorded: gender, age, body
weight, body mass index, body surface area, ASA-PS, type of surgery. The airway assessment
will include Mallampati score, thyromental distance, cervical spine mobility, upper lip bite
test, mouth opening, micrognathia, protruding incisors, beard, denture, snoring.
Patients will be randomly allocated into one of two groups: the S group was to be intubated
after inhalational anesthesia with Sevoflurane only and maintenance of anesthesia with
Sevoflurane 1MAC. The P group will receive standard anesthesia induction with propofol
1,5mg/Kg, fentanyl 2mcg/Kg, rocuronium 0,5mg/Kg, while anesthesia will be maintained by
sevoflurane.
Before induction of anesthesia, we will record baseline data including BIS, SpO2, heart rate,
invasive blood pressure, cardiac output, stroke volume, stroke volume variation, respiratory
rate, and arterial blood gas sample recordings.
During induction of anesthesia, the following data will be recorded: BIS, SpO2, heart rate,
invasive blood pressure, cardiac output, stroke volume, stroke volume variation, respiratory
rate, recordings from arterial blood gas sample, induction to anesthesia conditions (limb
movement, cough, salivation, laryngospasm, and apnea), respiratory rate, tidal volume, minute
volume, end-tidal CO2, the concentration of sevoflurane (inhaled, exhaled), peak inspiratory
pressure, mean inspiratory pressure, dynamic respiratory compliance. In the S group, these
data will be recorded again five minutes after the induction to anesthesia commencement.
During intubation, we will record BIS, SpO2, heart rate, blood pressure, cardiac output,
stroke volume, stroke volume variation, intubating conditions (jaw relaxation, vocal cord
position, vocal cord movement, limb movement, bucking), Cormack-Lehane grade, duration of
intubation.
After intubation we will register: BIS, SpO2, heart rate, invasive blood pressure, cardiac
output, stroke volume, stroke volume variation, respiratory rate, recordings from arterial
blood gas sample, respiratory rate, tidal volume, minute volume, end-tidal CO2, the
concentration of sevoflurane (inhaled, exhaled), peak inspiratory pressure, mean inspiratory
pressure, dynamic respiratory compliance, were recorded. Patients having abolished
spontaneous breathing will be set on the IMV mode of ventilation receiving tidal volume
8ml/Kg, 10 breaths/min, PEEP=5cmH2O, I: E=1:2, Plateau time 30%.
Upon the end of the surgical stimuli the following parameters will be registered: BIS, blood
pressure, heart rate, SpO2, stroke volume, stroke volume variation, cardiac output, etCO2,
respiratory rate, sevoflurane concentration (exhaled, inhaled), peak inspiratory pressure,
mean inspiratory pressure, dynamic compliance, time of establishing spontaneous breathing,
time of extubation.
BIS, blood pressure, heart rate, SpO2, stroke volume, stroke volume variation, cardiac
output, etCO2, the respiratory rate will be recorded 5 and 10 minutes respectively
post-extubation.