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Completed

NCT Number: NCT04802122

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AHEPA University Hospital

Thessaloniki, 54636, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane inhalant product

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.

Other names: Sevoflurane

Propofol Fresenius

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. .

Other names: Propofol

Primary outcomes

  1. Intubating conditions

    Time frame: 10 minutes after induction to anesthesia commencement with sevoflurane or 5 minutes after induction to anesthesia with propofol plus fentanyl and muscle relaxant

    Modification of intubating conditions assessed by Cormack-Lehane classification system after induction to anesthesia with sevoflurane (without muscle relaxants) or standard induction to anesthesia involving propofol supplemented by fentanyl and muscle relaxant.

  2. Cardiac output compromise

    Time frame: Within 10 minutes after induction to anesthesia commencement with sevoflurane or 5 minutes after induction to anesthesia with propofol plus fentanyl and muscle relaxant

    Cardiac index reduction defined CI < 2.2 L/min/m2 after induction to anesthesia with sevoflurane (without muscle relaxants) or standard induction to anesthesia involving propofol supplemented by fentanyl and muscle relaxant.

Secondary outcomes

  1. Hypercapnia

    Time frame: 1 minute after intubation

    The occurrence of hypercapnia defined as carbon dioxide partial pressure > 45 mmHg in arterial blood gas sample after induction to anesthesia with sevoflurane (without muscle relaxants) or standard induction to anesthesia involving propofol supplemented by fentanyl and muscle relaxant.

  2. Hypotension

    Time frame: Within10 minutes after induction to anesthesia commencement with sevoflurane or 5 minutes after induction to anesthesia with propofol plus fentanyl and muscle relaxant

    Duration of hypotension defined as systemic arterial pressure < 90mmHg after induction to anesthesia with sevoflurane (without muscle relaxants) or standard induction to anesthesia involving propofol supplemented by fentanyl and muscle relaxant.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Comparative Assessment of Intubating Conditions and Cardiorespiratory Effects of Sevoflurane Induction and Intubation.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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