Not Yet RecruitingPhase 3ACTRN12606000522516

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.


Sponsor

Dr Doug Campbell

Enrollment

60 participants

Start Date

Jul 1, 2006

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 100 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates how two anesthesia drugs (remifentanil and sevoflurane) interact during surgery. It is for adults aged 18 to 100 who are having surgery expected to last at least 1.5 hours with minimal blood loss. Participants must be in generally stable health (ASA grade 1-3) and able to speak English fluently.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 durati

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.


Locations(1)

New Zealand

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ACTRN12606000522516