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Sevoflurane for maintenance of anaesthesia in major vascular surgery: using the bispectral index to determine the minimum alveolar concentration

Minimum alveolar concentration of sevoflurane to maintain bispectral index below 50 in major vascular surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000846729
Enrollment
25
Registered
2013-08-01
Start date
2013-05-06
Completion date
2013-07-25
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aim to determine the minimum alveolar concentration of sevoflurane to maintain the bispectral index below 50 in 95% of patients undergoing major vascular surgery. This will permit to better choose sevoflurane concentration that allow an adequate anaesthesia with a minimal risk of memorisation even when bispectral index is unavailable.

Interventions

ASA physical status I and II patients scheduled to undergo major vascular surgery are enrolled in this study. Monitoring consists on blood pressure, heart rate, pulse oxymetry, endtidal CO2, entidal sevoflurane and bispectral index. Induction of anaesthesia is standardized in all patients using target controlled infusion of propofol and remifentanil. Muscle relaxation is achieved with cisatracurium. After tracheal intubation, propofol infusion is stopped. When the bispectral index reach 65 sev

ASA physical status I and II patients scheduled to undergo major vascular surgery are enrolled in this study. Monitoring consists on blood pressure, heart rate, pulse oxymetry, endtidal CO2, entidal sevoflurane and bispectral index. Induction of anaesthesia is standardized in all patients using target controlled infusion of propofol and remifentanil. Muscle relaxation is achieved with cisatracurium. After tracheal intubation, propofol infusion is stopped. When the bispectral index reach 65 sevoflurane inhalation is started at the predetermined concentration. The predetermined endtidal concentration for the first patient is 2%. Sevoflurane is used once only to maintain anaesthesia. The endtidal sevoflurane concentration is adjusted with starting dose of 2% for the first patient and maintained for 10 min to ensure equilibration with the cerebral anesthetic partial pressure followed by assessment of BIS. In the next patients doses are given according to the following rule: if the subject responds positively (BIS<50 after 10 minutes of sevoflurane), the endtidal concentration is decreased by 0.2% step for the next subject, and conversely, if the subject does not respond (BIS>50 after 10 minutes of sevoflurane), the dose is increased by 0.2% step. The ED50 and ED95 of sevoflurane to maintain bispectral index below 50 are calculated using probit transformation.

Sponsors

Military Hospital of Tunis
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

ASA I or II adults scheduled to undergo major vascular surgery under general anaesthesia

Exclusion criteria

Known allergy to sevoflurane Previous renal disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026