Sevoflurane Wash in Method Using Conventional Flows Versus Low Flows of 0.5L

NCT06209112 | Completed FDA Drug

• 1 other identifier: MoH/CSR/23/27624
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to to evaluate a technique of initiating Sevoflurane low-flow anesthesia which is simple, has a quick wash-in and minimises gas consumption without compromising the safety when compared to conventional method of attaining low-flow anesthesia using initial high flows. Participants will explained about the procedure of induction of general anesthesia using either one of the above two methods and written consent will be obtained prior to inclusion in the study.

Conditions

Inhalation; Gas

Outcome Measures

Primary Outcomes (1)

• Time required to achieve alveolar concentration of sevoflurane at 2%

  The primary outcome will be the time required to achieve FAS 2%.

  15 minutes

Secondary Outcomes (1)

• To know the stability of the circle system

  15 minutes

Study Arms (2)

Conventional group' (Group C)

The 'conventional' group (Group C): FGF will be set to 6 L/min and the FVS 3% at Tzero. The FGF will be reduced to 0.5 L/min upon reaching FAS 2%. Hereafter, the FVS will be set to 4% and maintained till 15 min (T15) from Tzero.

Drug: Sevoflurane

Over-pressure group' (Group OP)

The 'over-pressure' group (Group OP): FGF will be set to 0.5 L/min and FVS 8% at Tzero. Subsequently, the FVS will be set to 4% upon reaching FAS 2% and maintained till 15 min (T15) from Tzero.

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

The time of reaching FAS=2% will be noted in both the groups. The time taken in seconds from Tzero to reach FAS 2% (Ttarget) will be calculated. Inspired concentration of Sevoflurane (FIS), FAS, and age-adjusted MAC will be retrieved from the automatically recorded 'trend' of parameters. FIS, FAS and age-adjusted MAC will be noted every 30 sec. starting from Tzero, till T5 and every minute thereafter until T15.

Conventional group' (Group C); Over-pressure group' (Group OP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Forty-eight patients of either gender aged 18-65 years, with American Society of Anesthesiologists (ASA) physical status of 1-2, undergoing elective surgery with the expected duration more than 1 hour under general anaesthesia requiring endotracheal intubation will be included.

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status 1 and 2
• elective surgery with the expected duration more than 1 hour under general anaesthesia requiring endotracheal intubation

You may not qualify if:

• Pregnant women
• smokers
• patients with a body mass index (BMI) ≥30 kg/m2
• cardiac/pulmonary/renal or liver impairments
• upper or lower respiratory infections within the past 6 weeks and anticipated difficult airway will be excluded.

Sponsors & Collaborators

• Royal Hospital, Oman: lead

Study Sites (1)

The Royal Hospital, Muscat

Muscat, Mucsat, 112, Oman

Location

Related Publications (6)

• Baum JA. Low-flow anesthesia: theory, practice, technical preconditions, advantages, and foreign gas accumulation. J Anesth. 1999;13(3):166-74. doi: 10.1007/s005400050050. No abstract available.

  PMID: 14530937 BACKGROUND

• Brattwall M, Warren-Stomberg M, Hesselvik F, Jakobsson J. Brief review: theory and practice of minimal fresh gas flow anesthesia. Can J Anaesth. 2012 Aug;59(8):785-97. doi: 10.1007/s12630-012-9736-2. Epub 2012 Jun 1.

  PMID: 22653840 BACKGROUND

• Tribuddharat S, Sathitkarnmanee T, Vattanasiriporn N, Thananun M, Nonlhaopol D, Somdee W. 1-1-8 one-step sevoflurane wash-in scheme for low-flow anesthesia: simple, rapid, and predictable induction. BMC Anesthesiol. 2020 Jan 24;20(1):23. doi: 10.1186/s12871-020-0940-2.

  PMID: 31980020 BACKGROUND

• Horwitz M, Jakobsson JG. Desflurane and sevoflurane use during low- and minimal-flow anesthesia at fixed vaporizer settings. Minerva Anestesiol. 2016 Feb;82(2):180-5. Epub 2015 Jul 22.

  PMID: 26198766 BACKGROUND

• Jakobsson P, Lindgren M, Jakobsson JG. Wash-in and wash-out of sevoflurane in a test-lung model: A comparison between Aisys and FLOW-i. F1000Res. 2017 Mar 29;6:389. doi: 10.12688/f1000research.11255.2. eCollection 2017.

  PMID: 28529707 BACKGROUND

• Upadya M, Saneesh PJ. Low-flow anaesthesia - underused mode towards "sustainable anaesthesia". Indian J Anaesth. 2018 Mar;62(3):166-172. doi: 10.4103/ija.IJA_413_17.

  PMID: 29643549 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration; Mucopolysaccharidosis IV

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Harihar V Hegde, MD

  The Royal Hospital, Oman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Anesthesia & Intensive Care, The Royal Hospital

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 17, 2024
• Study Start: January 30, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

OM (1)