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. 2018 Aug 21;2018(8):CD012317. doi: 10.1002/14651858.CD012317.pub2

Lindholm 2013.

Methods RCT, parallel design, single‐centre
Participants Total number of randomized participants: 200
Inclusion criteria
  1. People with AAA or aortic arteriosclerosis obliterans, or both, scheduled for open abdominal aortic surgery


Excluded criteria
  1. < 18 years of age

  2. Included in other pharmaceutical studies

  3. Abuse of opioids, benzodiazepines, antiepileptic drugs, alcohol, or alpha2‐agonists

  4. Pregnant and breastfeeding women

  5. Family history of malignant hyperthermia

  6. Known hypersensitivity for opioids, propofol, or volatile anaesthetics

  7. Serious arrhythmias, ventricular fibrillation/tachycardia or tachycardia > 100 beats/min

  8. Severe valvular diseases requiring surgical repair before major noncardiac surgery

  9. Uncontrolled hypertension

  10. Serious psychiatric disease

  11. Unstable angina pectoris or MI 30 days before inclusion

  12. Acute abdominal aortic surgery

  13. Planned laparoscopic AAA surgery


Type of surgery: open abdominal aortic surgery
Baseline characteristics
TIVA group
  1. Age, mean (SD): 67 (± 9) years

  2. Gender, M/F: 72/24

  3. ASA grade: ASA II: 34; ASA III: 49; ASA IV: 13


Inhalational maintenance group
  1. Age, mean (SD): 69 (± 9) years

  2. Gender, M/F: 73/24

  3. ASA grade: ASA II: 36; ASA III: 47; ASA IV: 14


Country: Norway
Setting: hospital
Interventions TIVA group
Participants: n = 100; losses unclearly reported; 96 analysed (PP)
Induction details : premedication with paracetamol. Fentanyl 0.1 mg to 0.3 mg IV, and propofol 1 mg/kg to 2 mg/kg IV. Vecuronium 0.1 mg/kg, and 0.01 mg/kg to 0.02 mg/kg based on train‐of‐four
Maintenance details: propofol 1 mg/kg/hour to 10 mg/kg/hour IV, and remifentanil 0.1 mg/kg/min to 0.7 mg/kg/min. Aim to maintain BIS 40 to 60.
Additional regional anaesthesia: epidural 3 mL/hour to 12 mL/hour (bupivacaine 1 mg/mL, fentanyl 2 µg/mL, adrenaline 2 µg/mL)
Other information: morphine 1 mg to 10 mg IV as rescue analgesia
Inhalational maintenance group
Participants: n = 100; losses unclearly reported; 97 analysed (PP)
Induction details : premedication with paracetamol as for TIVA. Fentanyl 0.1 mg to 0.3 mg IV and thiopental sodium 3 mg/kg to 6 mg/kg IV. Vecuronium as for TIVA
Maintenance details: balanced anaesthesia with sevoflurane at 0.7 MAC to 1.5 MAC, and repeated doses of fentanyl 0.05 mg to 0.1 mg IV. Aim to maintain BIS 40 to 60
Additional regional anaesthesia: epidural 3 mL/hour to 12 mL/hour (bupivacaine 1 mg/mL, fentanyl 2 µg/mL, adrenaline 2 µg/mL)
Other information: morphine same as TIVA group
Outcomes
  1. Troponin T levels on first postoperative day

  2. Postoperative complications, to included cognitive dysfunction (at 30 days)

  3. Non‐fatal coronary events including acute MI

  4. Non‐thrombotic troponin increase

  5. Mortality (at 30 days)

  6. Use of inotropic‐, vasodilator‐ , and anaesthetic drugs

  7. Bleeding, urine output, tachycardia, bradycardia, hypotensive and hypertensive episodes during surgery

  8. Ischaemic events

  9. Arrhythmias

  10. Fluids and transfusions

  11. Postoperative pain

  12. Nausea and vomiting

  13. SOFA scores at 8 hours and first and second postoperative days

  14. Length of ward or ICU stay

  15. Length of hospital stay

Notes Funding/declarations of interest: institution or department funding. One author received fees for presentations at Baxter AS Norway
Study dates: February 2008 to February 2012
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were randomized to groups; no additional details
Allocation concealment (selection bias) Unclear risk Quote: "after informed consent was given, patients selected a blank envelope with the randomization code inside from a box containing envelopes for all remaining patients to be included."
Study does not report if envelopes were opaque and sealed. Unclear if this is a sufficient method to conceal group allocation
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not feasible to blind anaesthetists to intervention groups
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Postoperative care was blinded. However, study authors do not report who collected data for POCD
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Small loss of participant data. Reasons for losses are unclearly reported, however loss is < 10% and balanced between groups
Selective reporting (reporting bias) Unclear risk Prospective registration with clinical trials register (NCT00538421). However, outcomes are not reported in trials register documents; not feasible to assess risk of selective outcome reporting bias
Other bias Unclear risk Groups differ in use of fentanyl and remifentanil which presents methodological differences between groups