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Trial registered on ANZCTR


Registration number
ACTRN12620000198921p
Ethics application status
Submitted, not yet approved
Date submitted
28/01/2020
Date registered
20/02/2020
Date last updated
20/02/2020
Date data sharing statement initially provided
20/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the ways we put patients to sleep (anaesthesia) for weight loss surgery
Scientific title
SOOThe: Study of Obesity-reduction and Opiate-free Total Intravenous Anaesthesia (TIVA). Using TIVA in bariatric surgery improve the analgesia and reduce post operative nausea and vomiting.
Secondary ID [1] 300378 0
Nil Known
Universal Trial Number (UTN)
U1111-1247-3539
Trial acronym
SOOThe: Study of Obesity-reduction and Opiate-free Total Intravenous Anaesthesia
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Obesity 315998 0
Post operative pain 315999 0
Post Operative Nausea and Vomiting 316000 0
Post Operative Acute Rehabilitation 316001 0
Opiate Free Total Intravenous Anaesthesia 316002 0
Condition category
Condition code
Anaesthesiology 314271 314271 0 0
Anaesthetics
Anaesthesiology 314272 314272 0 0
Pain management
Diet and Nutrition 314273 314273 0 0
Obesity
Respiratory 314274 314274 0 0
Sleep apnoea
Anaesthesiology 314275 314275 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Opiate-Free TIVA General Anaesthesia Study Group :
[1.1] Induction: Intravenous (IV) Dexmedetomidine (0.5mcg/kg over 10 minutes), IV Ketamine (0.5mg/kg), IV Lignocaine (1.0mg/kg (to a maximum of 200mg)) IV Propofol (Marsh TCI Cpt 4mcg/ml) and IV Vecuronium (0.1mg/kg).
[1.2] Maintenance: IV Dexmedetomidine (0.5mcg/kg/hour), IV Ketamine (3mcg/kg/minute) and IV Lignocaine (1mg/kg/hour, to a maximum of 200mg/hour).
[1.3] Addition multimodal analgesia will include IV Parecoxib 40mg and Paracetamol (IV, 1mg). Pantoprazole (40mg) intravenous will be given to reduce pain from gastro-oesphageal reflux.
[1.4] IV Dexamethasone (0.2mg/kg to a maximum of 8mg), IV Droperidol (10mcg/kg, to a maximum of 600mcg) and IV Ondansetron (0.15mg/kg to a maximum of 4mg) will be administered intra-operatively.
[1.5] Application of subcutaneous Bupivacaine to the surgical port sites by the surgeons
[1.6] Reversal with IV Sugamaddex 200mg
[1.7] Standard PACU protocols for IV Oxycodone (1mg, 2 minutely to a maximum of 10mg) will be prescribed and titrated to pain by PACU Staff.
[1.8] Regular ondansetron (4mg every 8 hours waffer oral or IV) will be prescribed for the first 48 hours after surgery. Breakthrough anti-emetics of IV Metoclopramide 0.2mg/kg will be used.
The depth of anaesthesia will be measured through Sedline Brain monitoring and the doses of drugs will be confirmed through study documentation and analysis of the anaesthetic chart.
Intervention code [1] 316658 0
Treatment: Drugs
Comparator / control treatment
Volatile and Opiate General Anaesthesia Study Group:
[2.1] Induction: Intravenous (IV) Alfentanil 1mg, IV Propofol (4mg/kg), Inhaled Desflurane (1 Minimum Alveolar Concentration, MAC) and IV Vecuronium (0.1mg/kg).
[2.2] Maintenance: Inhaled Desflurane 1 MAC, IV Oxycodone (0.1mg/kg to a maximum of 10mg)
[2.3] Addition multimodal analgesia will include IV Parecoxib 40mg, Paracetamol (IV, 1mg). Pantoprazole (40mg) intravenous will be given to reduce pain from gastro-oesphageal reflux.
[2.4] IV Dexamethasone (0.2mg/kg to a maximum of 8mg), IV Droperidol (10mcg/kg, to a maximum of 600mcg) and IV Ondansetron (0.15mg/kg to a maximum of 4mg) will be administered intra-operatively. .
[2.5] Application of subcutaneous Bupivacaine to the surgical port sites by the surgeons.
[2.6] Reversal with IV Sugamaddex 200mg.
[2.7] Standard PACU protocols for IV Oxycodone (1mg, 2minutely to a maximum of 10mg) will be prescribed and titrated to pain by PACU Staff.
[2.8] Regular ondansetron (4mg every 8 hours, waffer oral or IV) will be prescribed for the first 48 hours after surgery. Breakthrough anti-emetics of IV Metoclopramide 0.2mg/kg will be used.
Control group
Active

Outcomes
Primary outcome [1] 322662 0
The primary outcome measure is the post operative pain measured by analgesic requirement as measured by the total dose of opiates used in PACU, days 1 and 2 on the surgical ward.
Timepoint [1] 322662 0
PACU, Day 1 and Day 2 after surgery
Secondary outcome [1] 379224 0
Post operative pain as measured by the QoR-40 pain score

Timepoint [1] 379224 0
PACU, Day 1 and Day 2 after surgery
Secondary outcome [2] 379225 0
PONV as measured by the prescription of additional anti-emetic doses used as measured by the total dose of anti-emetic medication required used in PACU, days 1 and 2 on the surgical ward.
Timepoint [2] 379225 0
PACU, Day 1 and Day 2 after surgery
Secondary outcome [3] 379226 0
PONV as measured by the QoR-40 questionnaire in PACU
Timepoint [3] 379226 0
PACU, Day 1 and Day 2 after surgery
Secondary outcome [4] 379227 0
The time taken to reach acute rehabilitation as measured by the QoR-40 questionnaire
Timepoint [4] 379227 0
PACU, Day 1 and Day 2 after surgery

Eligibility
Key inclusion criteria
Elective, cognisant, adult patients booked for elective gastric reduction surgery
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
[1] Patients with a history of chronic pain
[2] Patients with a history of dementia or cognitive impairment
[3] Patients that do not wish to consent to the study
[4] Patients with a history of significant allergy or anaphylaxis to Ketamine, Propofol, Opiates and lignocaine
[5] Patients who are under 16 years of age or who are above 80 years of age

[6] Patients who plan not to be an inpatient for 48 hours following surgery
[7] Patients with a significant history of ischaemic heart disease (IHD) who have existing arrhythmias, low left or right ejection fraction (below 40%) or raised pulmonary blood pressure
[8] Patients already prescribed sodium channel blockers as part of the management of pre-existing IHD
[9] Pregnancy

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)
Group allocation will be placed in an opaque, sealed envelope that is sequentially numbered by an independent party who will not be collecting or analyzing data. This numbered envelop will be given to the clinical Anaesthetist after informed consent and the envelop will be opened prior to induction. Data will be collected during the operation but group allocation will not be recorded on data CRF. This data will be analysed without group allocation known.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be determined by block randomization sequence generated by a web-based computer random sequence generator (https://www.sealedenvelope.com) in blocks of four with a 1:1 allocation ratio.
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)
Efficacy
Statistical methods / analysis
Sample Size
The largest study published to date on Opiate free TIVA had 119 patients within it (Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11.) The study described here, which seeks to recruit 130 patients, is a pilot study which will establish proof of the principle. This will produce preliminary data that will form the basis of subsequent grant funding to ANZCA and the NHMRC for larger studies with greater power to assess the real role of TIVA within Bariatric Anaesthesia. None the less informal sampling of Bariatric patients undergoing both Volatile Opiate General Anaesthesia and Opiate Free TIVA suggests that the latter require 50 to 25% less opiate in PACU. On that basis a 50% difference in opiate prescription using a two sample means test would require 60 patients in each group (Total 130 patients) given an alpha value of 0.05 and a power of 0.8 assuming a standard deviation of 1.0.

Power Calculation
Assuming a statistically significant two way threshold of 0.05, a power of 0.8 and a standard deviation of 1.0 two sample means tests calculate:
[1] A sample size of 90 (total of 45 in each group) for a difference of 0.6 in opiate use in PACU
[2] A sample size of 106 (53 in each group) for a difference of 0.55 in opiate use in PACU
[3] A sample size of 128 (64 in each group) for a difference of 0.5 in opiate use in PACU.

Statistical Methods
All analyses will be performed using the statistical software package STATA (Stata 2017).
Continuous data will be described as normally distributed if they satisfy the Shapiro Wilk test. All continuous normally distribute data will be described as mean (+/- SD) and non-normally distributed data as median (interquartile range).

The primary and secondary outcomes will be analysed using paired t-test or Wilcoxon Signed Rank Test (depending on the distribution of normality). A two- sided alpha value of 5% is specified as significant.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15701 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 15702 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 29122 0
3084 - Heidelberg
Recruitment postcode(s) [2] 29123 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 304802 0
Hospital
Name [1] 304802 0
Department of Anaesthesia
Address [1] 304802 0
Austin Hospital,
145 Studley Road,
Heidleberg
Victoria 3084
Country [1] 304802 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia
Address
Austin Hospital,
145 Studley Road,
Heidleberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 305123 0
None
Name [1] 305123 0
Address [1] 305123 0
Country [1] 305123 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305217 0
Austin HREC
Ethics committee address [1] 305217 0
Level 2, Austin Tower, 145 Studley Road, Heidleberg, Victoria, 3084
Ethics committee country [1] 305217 0
Australia
Date submitted for ethics approval [1] 305217 0
28/01/2020
Approval date [1] 305217 0
Ethics approval number [1] 305217 0

Summary
Brief summary
Obesity is a major public health problem in both the developed and the developing world. A therapeutic approach that includes both bariatric surgery and medical management is more effective than medical management alone. However, bariatric patients are more prone to post operative complications that include post operative nausea and vomiting (PONV) and obstructive sleep apnea (OSA) both of which are caused by opiate administration. Despite the potential for both total intravenous anaesthesia (TIVA) and lignocaine infusions to reduce both of these morbidities there are few published reports in the literature on their use in bariatric patients. We propose to perform a pilot study in which patients are randomised to opiate free TIVA (Dexmedetomidine, Ketamine, Lignocaine and Propofol) or standard volatile-opiate based general anaesthesia and post operative care. We postulate that opiate free TIVA will provide improved analgesia, reduce PONV, cause less respiratory adverse events and lead to better post surgical rehabilitation. Ultimately we seek to establish a program of research which assesses the best method of Anaesthesia in Bariatric Patients. Pilot data will be used in grant applications to the Australian and New Zealand College of Anaesthetists (ANZCA) and the National Health and Medical Research Council (NHMRC).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99646 0
Dr Douglas Hacking
Address 99646 0
Staff Anaesthetist, Department of Anaesthesia,
Austin Hospital, Austin Health,
145 Studley Road, Heildleberg, Victoria 3084
Country 99646 0
Australia
Phone 99646 0
+610419629041
Fax 99646 0
Email 99646 0
Doug.HACKING@austin.org.au
Contact person for public queries
Name 99647 0
Dr Douglas Hacking
Address 99647 0
Staff Anaesthetist, Department of Anaesthesia,
Austin Hospital, Austin Health,
145 Studley Road, Heildleberg, Victoria 3084
Country 99647 0
Australia
Phone 99647 0
+610419629041
Fax 99647 0
Email 99647 0
Doug.HACKING@austin.org.au
Contact person for scientific queries
Name 99648 0
Dr Douglas Hacking
Address 99648 0
Staff Anaesthetist, Department of Anaesthesia,
Austin Hospital, Austin Health,
145 Studley Road, Heildleberg, Victoria 3084
Country 99648 0
Australia
Phone 99648 0
+610419629041
Fax 99648 0
Email 99648 0
Doug.HACKING@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient Privacy concerns in a vulnerable population
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 6643 0
Study protocol
Citation [1] 6643 0
Link [1] 6643 0
Email [1] 6643 0
Other [1] 6643 0
Type [2] 6644 0
Informed consent form
Citation [2] 6644 0
Link [2] 6644 0
Email [2] 6644 0
Other [2] 6644 0
Summary results
No Results