ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000806763

Ethics application status

Approved

Date submitted

17/07/2013

Date registered

22/07/2013

Date last updated

31/07/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomized trial of sevoflurane versus desflurane on the quality of recovery following knee arthroscopy

Scientific title

A randomized trial of sevoflurane versus desflurane on the quality of recovery following knee arthroscopy

Secondary ID [1]

nil

Universal Trial Number (UTN)

U1111-1145-7074

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

recovery following knee arthroscopy

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Common management for both groups will include the following:

1. Pre-medication other than oral analgesic (such as paracetamol) will not be used.
2. Induction will be with intravenous propofol (50-200mg), including co-induction consisting of fentanyl 25-100 micrograms and midazolam 1-5 mg. Antimemetics including dexamethasone and 5HT3 antagonists (such as ondansetron) may be administered by the treating anaesthetist.
3. Analgesia will consist of intraoperative opiates, 1 g paracetamol orally four times per day, intravenous opiates during early recovery (such as fentanyl up to 30 mionutes after surgery), Morphine 2.5-10mg subcutaneously 3 hourly, or oral oxynorm 10-20mg 6 hourly will be used for breakthrough analgesia. NSAIDs including Cox II inhibitors (such as paracoxib 40mg intravenously may be used.
4. Patients will not be included in the study if the treating anaesthetist considers that a regional anaesthetic rather than a general anaesthetic would be in the best interest of the patient. This would most likely be a spinal anaesthetic.

Intervention drug.
Following induction of general anaesthesia either desflurane or sevoflurane via inhalation will be introduced as the maintenance anaesthetic and titrated to maintain an adequate clinical depth of anaesthesia for the remainder of the operation and stopped after the last skin stitch is completed. Typically this will involve inhaled anaesthetic concentrations of 6% desflurane and 2.0% sevoflurane, reflecting the different potencies of the drugs. If Bispectral index monitoring (depth of anaesthesia monitor) is available, the target range is 40-60.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Comparison of two anaesthetic agents - sevoflurane and desflurane

Control group

Active

Outcomes

Primary outcome [1]

Quality of recovery, as measured by the postoperative quality recovery scale (PQRS) at Day 3 for recovery in all of the individual recovery domains (all domains recovery).

Timepoint [1]

Day 3 postoperative

Secondary outcome [1]

Recovery for all domains measured by the postoperative quality of recovery scale (PQRS) at the other time points of measurement (15 minutes, 40 minutes 1 day, 3 days and 3 months following cessation of anaesthesia).

Timepoint [1]

15 minutes, 40 minutes 1 day, 3 days and 3 months following cessation of anaesthesia

Eligibility

Key inclusion criteria

1. Adult patients undergoing knee arthroscopy surgery under general anaesthesia

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients who are not fluent in English will be excluded, as they may be unable to answer the recovery questionnaire adequately.
2. Patients undergoing regional anaesthesia only.
3. Unable to give informed consent.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Concealment will be by placing the card containing the allocation information in double opaque sealed envelopes, and concealment will be maintained until after recruitment and the patients is admitted into the operating theatre. The treating anaesthetist will then open the envelopes to reveal the allocation. A non-participant in any process of the study will perform preparation of the envelopes. A copy of the randomization sequence will be stored in a separate databank, which is password protected and not available to the investigators until the study is complete.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomization sequence will by produced using a computer generated randomization sequence.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

The primary endpoint will be assessed using a comparison of two proportions. Recovery profiles over time will be compared using the Cochran Mantel Haenszel test for repeated measurement of proportions, and will test the global hypothesis for difference between groups over time.

Sample-size estimates are based on the pilot data for all domains recovery at day 3 (desflurane 35.2% vs. sevoflurane 20%) and using Fisher’s exact method test to determine a difference of 10% difference in the total score using a 2-tailed test with 80% power at a P=0.05 significance. The minimal sample size is 137 for each group. This will be increased to 150 patients per group to account for potential non-completions.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

12/08/2013

Actual

3/09/2013

Date of last participant enrolment

Anticipated

31/07/2015

Actual

1/02/2017

Date of last data collection

Anticipated

Actual

2/05/2017

Sample size

Target

300

Accrual to date

Final

300

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Epworth Richmond - Richmond

Recruitment hospital [2]

Epworth Eastern Hospital - Box Hill

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

The University of Melbourne

Address

Grattan Street Parkville VIC 3010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Epworth Hospital HREC

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/07/2013

Ethics approval number [1]

Summary

Brief summary

Aims: To identify whether the quality of recovery over time is affected by sevoflurane versus desflurane when used as the primary anaesthetic for knee arthroscopy surgery.

Significance: Quality of recovery is an emerging field within anaesthesia of great importance.  Although large outcome studies are very important in anaesthesia, there is a changing focus from “mortality and morbidity studies”, to quality of recovery. The reason is that the frequency of mortality is now very low with the result that few interventions will further reduce mortality. Very large numbers are required to demonstrate any improvements in surgery and anaesthesia when mortality is used as an outcome. However early data on the PQRS as well as clinical reports indicate that the quality of recovery is often poor in many patients, and yet these are not identified by the treating anaesthetist.  There are implications for the individual patient, for the practice of anaesthesia, and for the community (such as safe return to work or to driving). Knee arthroscopy is often performed as an outpatient (day) procedure, and therefore may be perceived as “minor surgery”. However, for some patients the quality of recovery including cognitive decline may be more profound than would be expected from brief peripheral surgery. The role of the anaesthetic agent may have an important influence on this recovery. It is frequently assumed by anaesthetists that anaesthetics from the same class should produce similar effects when administered for a brief anaesthetic, but there are insufficient data to validate that assumption. This study will help anaesthetists to choose the anaesthetic that is best for their patients undergoing brief surgery.

Hypothesis: The null hypothesis is that there is no difference in recovery in all domains measured using the PQRS, in patients undergoing knee arthroscopy under general anaesthesia with either sevoflurane or desflurane as the primary anaesthetic

Methods: A parallel group, randomised trial with 1:1 allocation ratio will be conducted in adult patients undergoing arthroscopy, where the intervention is to receive sevoflurane or desflurane as the primary anaesthetic agent.   Quality of recovery will be measured using the Post-operative Quality of Recovery Scale (PQRS), at baseline (preoperative), 15 and 40 minutes, one and three days, and three months following surgery. Patients who are unable to complete the PQRS due to language limitations, or who will receive  regional anaesthesia will be excluded.   Recovery is defined as “return to baseline values or better” for each of the survey questions and is dichotomised to recovered or not recovered.  Recovery is grouped within domains (physiological, emotive, nociceptive, cognitive, and activities of daily living, with a sixth domain of self-assessment). The primary endpoint will be the incidence of recovery for all domains (not including self-assessment) on the third day after surgery.  Based on a pilot study performed at the Epworth Hospital, we estimate the ability to detect a clinically important difference with 150 patients in each group.   Guidelines for other aspects of patient care including co-induction agents, antiemetics, and post-operative analgesics will be issued to reduce variability between patients.

Likely benefits:  There are pharmacological differences between sevoflurane and desflurane that make them more or less attractive to the anesthetist.  Desflurane, should provide for earlier and more complete recovery then sevoflurane, but sevoflurane is an easier drug to administer due to a lower incidence of airway irritability. There are very few data investigating quality of recovery with these two drugs beyond emergence and PACU care.  This study will provide data into whether there are longer-term differences in the quality of recovery between these two drugs.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Colin Royse

Address

The University of Melbourne
245 Cardigan St
Carlton, Vic 3053

Country

Australia

Phone

+61390354704

Fax

[email protected]

Contact person for public queries

Name

Colin Royse

Address

The University of Melbourne
245 Cardigan St
Carlton, Vic 3053

Country

Australia

Phone

+61390354704

Fax

[email protected]

Contact person for scientific queries

Name

Colin Royse

Address

The University of Melbourne
245 Cardigan St
Carlton, Vic 3053

Country

Australia

Phone

+61390354704

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Studies have described different recovery profiles... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A randomized trial of desflurane or sevoflurane on postoperative quality of recovery after knee arthroscopy.	2019	https://dx.doi.org/10.1371/journal.pone.0220733

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically