Induction of Anesthesia With Sevoflurane Preserving Spontaneous Breathing: Cardiorespiratory Effects.

NCT ID: NCT04802122

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-24
• Study Completion Date: 2021-07-14

Brief 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.

Detailed 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.

Conditions

Anesthesia Intubation Complication; Cardiovascular Complication; Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sevoflurane group

Patients in this group will receive Sevoflurane 8% / O2 100% with the vital capacity breathing method (vital capacity induction, VCI) for induction to anesthesia and to facilitate endotracheal intubation (without the use of muscle relaxant) and thereafter Sevoflurane 1 MAC will be used for maintenance of anesthesia plus muscle relaxant until study completion.

Group Type: EXPERIMENTAL

Sevoflurane inhalant product

Intervention Type: DRUG

Sevoflurane 8% / O2 100% with the vital capacity breathing method (vital capacity induction, VCI) will be used for induction to anesthesia and facilitate endotracheal intubation.

Propofol group

Patients in this group will receive a standard anesthesia induction involving Propofol 1,5mg/Kg, supplemented by fentanyl 2mcg/Kg and rocuronium 0,5mg/Kg and O2 100% for induction to anesthesia and to facilitate endotracheal intubation and thereafter Sevoflurane 1 MAC will be used for maintenance of anesthesia.

Group Type: ACTIVE_COMPARATOR

Propofol Fresenius

Intervention Type: DRUG

Propofol 1,5mg/Kg, supplemented by fentanyl 2mcg/Kg and rocuronium 0,5mg/Kg and O2 100% will be for induction to anesthesia and facilitate endotracheal intubation. .

Interventions

Sevoflurane inhalant product

Sevoflurane 8% / O2 100% with the vital capacity breathing method (vital capacity induction, VCI) will be used for induction to anesthesia and facilitate endotracheal intubation.

Intervention Type: DRUG

Propofol Fresenius

Propofol 1,5mg/Kg, supplemented by fentanyl 2mcg/Kg and rocuronium 0,5mg/Kg and O2 100% will be for induction to anesthesia and facilitate endotracheal intubation. .

Intervention Type: DRUG

Other Intervention Names

Sevoflurane; Propofol

Eligibility Criteria

Inclusion Criteria

• Age >18 and < 71 years
• ASA-PS 1-3 (American Society of Anesthesiologists Physical Status classification)
• General anesthesia for abdominal surgery
• Elective cases
• Signed informed consent

Exclusion Criteria

• Urgent/emergency surgeries
• BMI<18.5 or BMI>34.9
• Intraabdominal hypertension
• Gastroesophageal reflex
• Pregnancy
• Liver or renal failure
• intracranial hypertension

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Georgia Tsaousi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vasilios Grosomanidis

Role: STUDY_DIRECTOR

Aristotle University Of Thessaloniki

Locations

AHEPA University Hospital

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

INTUSEVO

Identifier Type: -

Identifier Source: org_study_id