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Testing for interactions between anaesthetic drugs

The use of response modelling to define the interaction between sevoflurane and remifentanil as measured by Observer Assessment Sleep and Sedation (OASS) score and bispectral index during general anaesthesia.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000522516
Enrollment
60
Registered
2006-12-18
Start date
2006-07-01
Completion date
Unknown
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

General anaesthesia is a complex process requiring many drugs being given to a patient and monitoring their effect on organs like the heart, lungs and brain. These drugs can have similar actions but the combined effects can be complicated and difficult to predict because of large variations of drug dosing and differences in patient responses. This study aims to establish the interaction between sevofularane and remifentanil across a wide variety of doses for different anaesthesia and endpoints

Interventions

That response surface methodology (a technique that models the pharmacodynamic effect of two and three drug combinations) can define the interaction between sevoflurane and remifentanil for the duration of a general anaesthetic (approx 2 hrs). Remifentanil intravenously dose range 0.05 & 0.25%mcg/kg/min, and will be incremented. Sevoflurane dose range will be 0.25-1.25% mcg/kg/min. One drug will be randomly assigned as the start drug and ramped up to a preset randomly selected dose within the d

That response surface methodology (a technique that models the pharmacodynamic effect of two and three drug combinations) can define the interaction between sevoflurane and remifentanil for the duration of a general anaesthetic (approx 2 hrs). Remifentanil intravenously dose range 0.05 & 0.25%mcg/kg/min, and will be incremented. Sevoflurane dose range will be 0.25-1.25% mcg/kg/min. One drug will be randomly assigned as the start drug and ramped up to a preset randomly selected dose within the dose range (sevoflurane 0.25, 0.5, 0.75, 1.0 or 1.25%, remifentanil 0.05, 0.1, 0.15, 0.2 or 0.25%mcg/kg/min) then second drug will be introduced and ramped up until OASS score of 5 is attained. Doses will be incremented once 5 plasma half times have elapsed to allow equilibration at the effect site. This will approximately 5 mins for each increment. Increments will be ceased when patient is OASS 5 (unconscious and able to tolerate laryngoscopy) at which stage the patient will be intubated and preparations for surgery to be continued.

Sponsors

Dr Doug Campbell
Lead SponsorIndividual

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1) American Society Anaesthesiology Grade (ASA) grade 1-3 (healthy or with mild or moderate but stable disease). 2) Surgery usually associated with minimal blood loss and expected to last at least 1.5hrs.

Exclusion criteria

1) Contraindication to using reminfentanil or sevoflurane - including allergy and malignant hyperpyrexia2) inability to converse fluently in English.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026