Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001353381
Ethics application status
Approved
Date submitted
2/09/2017
Date registered
26/09/2017
Date last updated
26/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quality of recovery after propofol vs sevoflurane anaesthesia: A randomised study in lumbar spinal surgery patients
Scientific title
Quality of recovery after propofol vs sevoflurane anaesthesia: A randomised study in lumbar spinal surgery patients
Secondary ID [1] 292797 0
Nil
Universal Trial Number (UTN)
U1111-1201-6165
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 304610 0
Back pain 304657 0
Weakness 304658 0
Condition category
Condition code
Anaesthesiology 303931 303931 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Induction:
Fentanyl 1-3 mcg/kg bolus at the discretion of treating anaesthetist
Propofol IV bolus TCI, Schnider model, effect site concentration (mcg/mL) at induction to be recorded on anaesthetic chart. Dose at the discretion of treating anaesthetist.
Rocuronium 0.6 mg/kg IV
Endotracheal intubation: Females 7.0 mm (Internal diameter) and males 8.0 mm

Maintenance:
Propofol IV TCI, Schnider model, effect site concentration recorded at 15 minute intervals on anaesthetic chart. Dose at the discretion of treating anaesthetist.
Record total dose of propofol (in mg) on anaesthetic chart.
Maintenance anaesthesia titrated to BIS value 40 - 55. Dose at the discretion of treating anaesthetist
Mechanical ventilation tidal volume 6 - 10 mL/kg, resp rate titrated to ETCO2 30 - 40 mmHg
FiO2 0.5 (oxygen in air)
Body temperature maintained at 36 - 37 degrees Celsius (forced air warmer)
SBP maintained within 20% of pre-induction with use of fluids and vasopressor at anaesthetists discretion
Fentanyl boluses at discretion of treating anaesthetist
Rocuronium boluses at anaesthetist discretion
Parecoxib 40mg before the end of surgery, unless contraindicated
Reversal of rocuronium with neostigmine and glycopyrrolate dose at the discretion of the anaesthetist.
Anti-emetics: all patients to receive dexamethasone 4 mg IV and ondansetron 4 mg IV and no further anti-emetics intra-operatively.

PACU:
Fentanyl 20mcg bolus for pain, repeated at discretion of treating nurse
Anti-emetics at discretion of treating nurse, as charted by treating anaesthetist

Ward recovery
Oral oxycodone, 5-10 mg as required
Morphine subcutaneous 5 mg as required for breakthrough pain
Fentanyl PCA for participants with ongoing pain despite oral oxycodone and breakthrough morphine
Anti-emetics at discretion of ward nursing staff, as charted by treating anaesthetist
1 g 4 times a day oral paracetamol commencing immediately post-operatively
Intervention code [1] 299043 0
Treatment: Drugs
Comparator / control treatment
Induction:
Fentanyl 1-3 mcg/kg bolus IV at the discretion of treating anaesthetist
Propofol IV bolus TCI, Schnider model, effect site concentration (mcg/mL) at induction to be recorded on anaesthetic chart. Dose at the discretion of treating anaesthetist.
Rocuronium 0.6 mg/kg IV
Endotracheal intubation: Females 7.0 mm (Internal diameter) and males 8.0 mm

Maintenance:
Group S: Sevoflurane inhalation to maintain age-adjusted MAC 0.8 - 1.2
Maintenance anaesthesia titrated to BIS value 40 – 55. Dose at discretion of anaesthetist
Mechanical ventilation tidal volume 6 - 10 mL/kg, resp rate titrated to ETCO2 30 - 40 mmHg
FiO2 0.5 (oxygen in air)
Body temperature maintained at 36 - 37 degrees C (with use of forced air warmer)
SBP maintained within 20% of pre-induction value (with use of fluids and vasopressors at the discretion of the anaesthetist)
Fentanyl boluses at discretion of treating anaesthetist
Rocuronium boluses at anaesthetist discretion
Parecoxib 40mg before the end of surgery, unless contraindicated
Reversal of rocuronium with neostigmine IV and glycopyrrolate IV dose at the discretion of the anaesthetist.
Anti-emetics: all patients to receive dexamethasone 4 mg IV and ondansetron 4 mg IV and no further anti-emetics intra-operatively.

PACU:
Fentanyl 20mcg bolus for pain, repeated at discretion of treating nurse
Anti-emetics at discretion of treating nurse, as charted by treating anaesthetist

Ward recovery
Oral oxycodone, 5-10 mg as required
Morphine subcutaneous 5 mg as required for breakthrough pain
Fentanyl PCA for participants with ongoing pain despite oral oxycodone and breakthrough morphine
Anti-emetics at discretion of ward nursing staff, as charted by treating anaesthetist
1 mg x 4 day Paracetamol commencing immediately post-operatively
Control group
Active

Outcomes
Primary outcome [1] 303273 0
Change in QoR-40 scores twenty-four hours post-operatively in patients who have undergone general anaesthesia for lumbar laminectomy using propofol infusion as maintenance to those in whom sevoflurane inhalation is used as maintenance.
Timepoint [1] 303273 0
Baseline and 24 hours post operatively
Secondary outcome [1] 338498 0
Score on Pain Visual Analogue Scale
Timepoint [1] 338498 0
Pre-operatively and 24 hours post operation
Secondary outcome [2] 338499 0
Score on Nausea Visual Analogue Scale
Timepoint [2] 338499 0
Pre-operatively and 24 hours post operation
Secondary outcome [3] 338500 0
Presence of nausea in recovery room as recorder by nursing staff in recovery room notes
Timepoint [3] 338500 0
24 hours post operation
Secondary outcome [4] 338501 0
Dosage of anti-emetic medications administered
Timepoint [4] 338501 0
24 hours post operation
Secondary outcome [5] 338502 0
Total dose of opioids administered
Timepoint [5] 338502 0
24 hours post operation

Eligibility
Key inclusion criteria
Male and female patients undergoing one- or two-level lumbar laminectomy or discectomy
Age 18—65
BMI < 35
ASA 1-2
Willingness to give written consent and willingness to participate in and comply with the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with severe cardiovascular or respiratory disease
Patients with a history of significant post-operative nausea and vomiting
Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study
Patients taking regular opioid medications in a total dose greater than the equivalent of morphine 20 mg orally in 24 hours
Any known contraindication to either propofol intravenously or sevoflurane inhalationally
Pregnant or breastfeeding women.

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)
The chief investigator will assign allocation based on randomisation software. This will be placed in a sealed envelope and locked box along with the patients consent form. A blinded investigator will interview the patient the following day and remain unaware which group the patient has been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary study outcome is the QoR-40 score at 24 hours post-operatively. The sample size calculation is based on the assumption that a difference in QoR-40 score of 10 or more is significant. This results in a total of 80 participants, 40 in each group.
Analysis will be conducted after recruitment in a blinded manner.
No interim analysis will be conducted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
1/01/2019
Actual
Date of last data collection
Anticipated
2/01/2019
Actual
Sample size
Target
80
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8941 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 17312 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 297428 0
Hospital
Name [1] 297428 0
St Vincent's Hospital
Country [1] 297428 0
Australia
Primary sponsor type
Individual
Name
Samuel Boyers
Address
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 296424 0
None
Name [1] 296424 0
Address [1] 296424 0
Country [1] 296424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298538 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 298538 0
Ethics committee country [1] 298538 0
Australia
Date submitted for ethics approval [1] 298538 0
11/08/2016
Approval date [1] 298538 0
14/09/2016
Ethics approval number [1] 298538 0
HREC/16/SVH/219

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77386 0
Dr Samuel Boyers
Address 77386 0
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 77386 0
Australia
Phone 77386 0
+61 410 49 5720
Fax 77386 0
Email 77386 0
[email protected]
Contact person for public queries
Name 77387 0
Samuel Boyers
Address 77387 0
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 77387 0
Australia
Phone 77387 0
+61 410 49 5720
Fax 77387 0
Email 77387 0
[email protected]
Contact person for scientific queries
Name 77388 0
Samuel Boyers
Address 77388 0
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 77388 0
Australia
Phone 77388 0
+61 410 49 5720
Fax 77388 0
Email 77388 0
[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

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