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Aanesthetic Agents for Day Surgery - NIHR Health Technology ...

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Furthermore, anaesthetists operate in a resourceconstrained<br />

environment, and newer anaesthetic<br />

agents are invariably more costly than established<br />

agents. There<strong>for</strong>e, the anaesthetist has to justify<br />

the use of these agents, even if they are providing<br />

improved clinical outcomes or have increased<br />

patient acceptability. The literature provided little,<br />

poor-quality economic evidence, of which very little<br />

was sufficiently robust to support policy decisionmaking.<br />

Lack of evidence regarding the real comparative<br />

cost of different anaesthetic techniques,<br />

and the pressure to reduce spending on drugs in<br />

NHS hospitals compounds the difficulty faced by<br />

clinical practitioners and decision-makers.<br />

In the absence of clear guidance from the<br />

literature, clinical practitioners have little<br />

choice but to rely on their own experience and<br />

preferences, within local drug budget constraints.<br />

It is not surprising that the national survey carried<br />

out as part of the CESA project (see chapter 3)<br />

and the survey by Simpson and Russell 32 suggest<br />

that clinical practice is extremely variable in<br />

this area.<br />

The CESA project and CESA RCT were designed<br />

in response to a call <strong>for</strong> proposals from the UK<br />

NHS R&D HTA Programme. The call <strong>for</strong> proposals<br />

was based on a perceived need <strong>for</strong> additional<br />

in<strong>for</strong>mation about the relative effectiveness, costs<br />

and patient acceptability of alternative anaesthetic<br />

agents and techniques <strong>for</strong> day surgery to in<strong>for</strong>m<br />

practice in the UK NHS. The need <strong>for</strong> this<br />

in<strong>for</strong>mation in the UK was confirmed by the<br />

literature review and the survey of national<br />

practice, conducted as part of the CESA project.<br />

The research objectives and questions were<br />

developed to address this need.<br />

Anaesthetic regimens and treatment<br />

protocols<br />

The anaesthetic regimens were initially chosen to<br />

reflect practice in the UK when the trial proposal<br />

was developed in 1997. The literature review and<br />

the national survey of practice suggested that the<br />

agents, techniques and treatment protocol chosen<br />

<strong>for</strong> the adult RCT reflected current practice.<br />

However, the study did not cover all the regimens<br />

used in the UK. The agents and techniques<br />

used <strong>for</strong> the paediatric RCT were less reflective<br />

of current practice, with halothane now rarely<br />

being used <strong>for</strong> maintenance of anaesthesia. In<br />

addition, the survey indicated that prophylactic<br />

anti-emetics were routinely used in UK practice.<br />

This was expressly excluded from the treatment<br />

protocol, to increase the power of the trial to<br />

detect differences in the incidence of PONV<br />

© Queen’s Printer and Controller of HMSO 2002. All rights reserved.<br />

<strong>Health</strong> <strong>Technology</strong> Assessment 2002; Vol. 6: No. 30<br />

and minimise distortion of the relative costs of<br />

the regimens.<br />

To address these problems an extensive sensitivity<br />

analysis was undertaken to estimate the expected<br />

costs and effects if: (i) alternative anaesthetic<br />

agents, identified in the national survey, were<br />

substituted <strong>for</strong> the agents used in the paediatric<br />

CESA RCT; and (ii) prophylactic ondansetron<br />

was added to the anaesthetic regimens used in<br />

the adult CESA RCT. These analyses confirmed<br />

the results of the primary analysis that induction<br />

with propofol followed by propofol or a volatile<br />

agent <strong>for</strong> maintenance of anaesthesia is more<br />

cost-effective than induction and maintenance<br />

with sevoflurane.<br />

Trial population<br />

A number of factors may mean that the population<br />

of patients treated in the CESA RCT are<br />

not representative of the general population of<br />

patients receiving the day-surgery procedures used<br />

in this study. These are the eligibility criteria and<br />

willingness of patients to participate in the trial.<br />

The eligibility criteria restrict the generalisability<br />

of the results to patients undergoing the daysurgery<br />

procedures included in the CESA RCT<br />

(adult study – general, including urological<br />

surgery, orthopaedic surgery, gynaecological<br />

surgery; paediatric study – general surgery, ENT<br />

surgery), patients who do not require sedative<br />

premedication and patients who are not expected<br />

to need suxamethonium. The day-surgery procedures<br />

are commonly used and comprise a large<br />

proportion of all day surgery. The national practice<br />

survey indicates that the use of premedication and<br />

suxamethonium in routine UK practice is <strong>for</strong> less<br />

than 10% of patients. These factors would suggest<br />

that the eligibility criteria were unlikely to lead<br />

to an atypical trial population.<br />

There was no evidence that the demographic<br />

or clinical characteristics of the patients who<br />

refused to participate in the CESA RCT differed<br />

from those who did participate. Approximately<br />

half of the patients/parents who refused to<br />

participate in the CESA RCT did not want an<br />

inhalational anaesthetic. If the patients who<br />

participated in the trial were indifferent to<br />

whether they had intravenous or inhalational<br />

induction, the willingness to pay to have an<br />

intravenous induction found in the trial may<br />

be lower than that of the population treated in<br />

routine practice. Again this would suggest that<br />

the cost-effectiveness of anaesthetic regimens<br />

which use propofol <strong>for</strong> induction is robust and<br />

applicable to the general population.<br />

87

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