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

NCT04802122 | Completed Phase 4

• 1 other identifier: INTUSEVO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Intubation Complication; Cardiovascular Complication; Intubation

Keywords

inhalational; sevoflurane; cardiovascular; induction

Outcome Measures

Primary Outcomes (2)

• Intubating conditions

  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.

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

• Cardiac output compromise

  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.

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

Secondary Outcomes (2)

• Hypercapnia

  1 minute after intubation

• Hypotension

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

Study Arms (2)

Sevoflurane group

EXPERIMENTAL

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.

Drug: Sevoflurane inhalant product

Propofol group

ACTIVE COMPARATOR

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.

Drug: Propofol Fresenius

Interventions

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.

Also known as: Sevoflurane

Sevoflurane group

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. .

Also known as: Propofol

Propofol group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

MeSH Terms

Interventions

Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Vasilios Grosomanidis

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 17, 2021
• Study Start: May 24, 2021
• Primary Completion: July 13, 2021
• Study Completion: July 14, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)