Comparison of Propofol Target Controlled Infusion (TCI) and Sevoflurane
Condition: Vitreous Detachment
MeSH terms: Vitreous Detachment
Study type: Interventional

Summary: 
      This study was an experimental, single-blinded, randomized controlled trial that aimed to
      compare recovery time between TCI propofol and sevoflurane. After ethical approval from
      Research Ethical Committee Faculty of Medicine, Universitas Indonesia (879/UN2.F1/ETIK/2017)
      and informed consent, patients aged 18-65 years old, body mass index 18 - 30 kg/m2, American
      Society of Anesthesiologists (ASA) status I-II who were scheduled for vitrectomy surgery
      under general anesthesia, at Kirana's Eye Operating Theatre Cipto Mangunkusumo National
      Referral Hospital from September until December 2017, were recruited in this study. All
      subjects would be recruited with a consecutive sampling method and randomly assigned into two
      groups, the TCI propofol group and sevoflurane group. Block random allocation was done for
      all subjects by using the random allocator program Winpepi.
    

Detailed description: 
      This study was an experimental, single-blinded, randomized controlled trial that aimed to
      compare recovery time between TCI propofol and sevoflurane. After ethical approval from
      Research Ethical Committee Faculty of Medicine, Universitas Indonesia (879/UN2.F1/ETIK/2017)
      and informed consent, patients aged 18-65 years old, body mass index 18 - 30 kg/m2, American
      Society of Anesthesiologists (ASA) status I-II who were scheduled for vitrectomy surgery
      under general anesthesia, at Kirana's Eye Operating Theatre Cipto Mangunkusumo National
      Referral Hospital from September until December 2017, were recruited in this study. Patients
      with hemodynamic instability, allergy, raised intracranial pressure, and a history of
      hyperthermia malignant, were excluded from this study. Patients who have hearing disturbance,
      history of alcohol, opioid, or psychotropic drugs consumption before surgery, suffered from
      neuropsychiatric disease, and electrolyte imbalance was also excluded from this study.
      Patients who experience intraoperative cardiorespiratory disturbance, surgery duration less
      than 35 minutes or more than 3 hours and 30 minutes, and patients with temperature
      abnormalities before being extubated from LMA would be excluded from the trial.

      Sample size The sample size calculation was performed with the unpaired numerical analytic
      equation. At least eighteen subjects for each group should include in this study. With the
      ten percent dropout possibility, twenty subjects will be recruited for each group, resulting
      in a total sample size of 40 subjects. All subjects would be recruited with a consecutive
      sampling method and randomly assigned into two groups, the TCI propofol group and sevoflurane
      group. Block random allocation was done for all subjects by using the random allocator
      program Winpepi.

      Study Protocols Peripheral venous catheters were placed in all subjects. Subjects in the TCI
      propofol group had one specific intravenous catheter for propofol infusion apart from
      medication or intravenous fluid line. In comparison, subjects in the sevoflurane group were
      cannulated only with one venous catheter. Midazolam 0.05 mg/kg BW and fentanyl 1 mcg/kg BW
      were given as premedication. Subjects in the TCI Propofol group received TCI propofol
      (Schneider) with targeted Ce 4 -5 mcg/ml for anesthesia induction and maintenance. Subjects
      in the sevoflurane group received intravenous propofol 1 - 2 mg/kg BW. BIS scores in both
      groups was titrated down to 50. Laryngeal mask no.3 or no.4 was inserted three minutes after
      administering atracurium 0.25 mg/kg BW. All subjects were ventilated with tidal volume 8
      ml/kg BW, 12 times/minutes, oxygen fraction 50%.

      Subjects in the TCI propofol group received TCI propofol for anesthesia maintenance, Ce value
      was titrated until a targeted BIS score of 40-60 achieved. Subjects in the sevoflurane group
      received sevoflurane 2 volume%, which were titrated up/down every 5 minutes to get a targeted
      BIS score of 40-60. Blood pressure, heart rate, oxygen saturation, and BIS score were
      monitored every 5 minutes. Fentanyl 1 mcg/ kg BW was added if there was an increase in blood
      pressure, heart rate and or BIS score that couldn't be overcome by increasing the dose of TCI
      propofol or sevoflurane.

      Surgery was considered done when the palpebral retractor had been removed. After spontaneous
      ventilation reverted, neostigmine 0.04 mg/kg BW and atropine 0.04 mg/kg BW as a reversal
      agent were given. Laryngeal mask was removed when the anesthesia still deep enough and
      subjects were monitored afterward. Time when TCI propofol and sevoflurane were discontinued
      was recorded (T0). Time when the patient was fully awake and could follow simple orders such
      as raising hands was recorded (Tp). Recovery time was the duration from T0 to Tp. Unwanted
      events during recovery, such as agitation and nausea-vomiting were recorded. Total fentanyl
      usage during surgery was also recorded. Statistical analysis was performed using Statistical
      Product for Social Sciences (SPSS) software 21.0 for windows. T-Test or Mann-Whitney analysis
      was done depending on the data normality test.
    

Intervention name(s): TCI Propofol; Sevoflurane
Intervention type(s): Procedure; Procedure
Intervention description(s): Peripheral venous catheters were placed in all subjects. Subjects in the TCI propofol group had one specific intravenous catheter for propofol infusion apart from medication or intravenous fluid line. Subjects in the TCI Propofol group received TCI propofol (Schneider) with targeted Ce 4 -5 mcg/ml for anesthesia induction and maintenance. Subjects in the TCI propofol group received TCI propofol for anesthesia maintenance, Ce value was titrated until a targeted BIS score of 40-60 achieved.; subjects in the sevoflurane group were cannulated only with one venous catheter. Midazolam 0.05 mg/kg BW and fentanyl 1 mcg/kg BW were given as premedication. Subjects in the sevoflurane group received intravenous propofol 1 - 2 mg/kg BW.
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: vitrectomy; propofol; sevoflurane; TCI