Miscellaneous Trials

 

MASTER 2002

Question

Thoracic epidural for major abdo surgery

Type

·      Multi-centre, non-blinded RCT

Subjects

·      High risk patients, major abdo surgery

Groups

·      Epidural vs IV opioid 72 hours

Upshot

·      ↔Mortality and major morbidity
(↓3.6% but only powered to find ↓10%)

·      ↔Cancer recurrence

·      ↓Resp failure NNT 15

·      ↓Pain

Comments

·      Inadequately powered to address major morbidity and mortality

·      Epidural group: 50% didn’t follow the protocol (e.g. inadequate use, removed for unknown reason)

·      ERAS society still recommends TEA for major abdo surgery

·      TEA is the gold standard for pain relief

·      But risk of paraplegia or death is 1/6-12K (!)

 

IMPACT 2004

Question

PONV prevention and treatment

Type

·      Multi-centre, double-blinded RCT

Groups

·      Drug A vs drug B etc - PONV within 24 hours

Risk factors (adult)

·      Female

·      Non-smoker

·      PHx PONV or motion sickness

·      Opioid 3mcg/kg

Likelihood (adult)

·      0 risk factors: 10%

·      1 risk factor: 20%

·      2 risk factors: 40%

·      3 risk factors: 60%

·      4 risk factors: 80%

Treatment effect

·      Dexamethasone 4mg (25%)

·      Ondansetron 4mg (25%)

·      Droperidol 1.25mg (25% in women)

·      Avoidance of N2O

·      TIVA (20%)

Risk factors (paed)

·      Age >3 years

·      Surgery >30 mins

·      Strabisumus surgery

·      PHx PONV

Likelihood (paed)

·      0: 10%

·      1: 10%

·      2: 30%

·      3: 50%

·      4: 70%

 

NICE-SUGAR 2009

Backgound

·      In sick diabetics, hyperglycaemia is associated with poor outcome

Question

·      Is that relationship causal?

Population

·      Diabetics in ICU

Groups

·      Aggressive treatment BSL 4.5-6

·      Lax treatment: BSL <10

Result

·      Aggressive treatment increased mortality

Interpretation

·      Cells of diabetics become accustomed to hyperglycaemia

 

REASON 2010

Question

Predictors of poor outcome in elderly patients

Type

·      Prospective audit

Subjects

·      Non-cardiac surgery, >70 years

Pre-op risk factors

·      Age (80s 2x, 90s 4x)

·      ASA 3 (3x) or 4 (12x)

·      Albumin <30 (2.5x)

·      A&E admission (2x)

Post-op risk factors

·      ICU unplanned (3x)

·      Inflammation systemically (2.5x)

·      Impairment of renal function (3x)

 

PADDI:

Question

Dexamethasone anti-emetic and infection risk

Outcome

·      TBC

 

ROCKet

Question

Ketamine for preventing chronic pain

Subjects

·      Abdo, thoracic, joint replacement surgery

Outcome

·      TBC

 

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