Remifentanil on Hemodynamic Response to Anesthesia Induction
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Effects of different doses of remifentanil on hemodynamic response to anesthesia induction in
      elderly patients ABSTRACT OBJECTİVE: The investigators compared the effects of three
      different doses of remifentanil infusion, which have been performed for the induction of
      anesthesia in elder patients, on cardiovascular response.

      PATIENTS AND METHODS: The present study was designed as a randomized, prospective and
      double-blind study. A total of 90 ASA I-II patients over the age of 65 years were enrolled
      and each group consisted of 30 subjects. The patients were randomly (by lot) assigned to
      receive one of the three doses of remifentanil infusion (0.1, 0.2 or 0.3 µg/kg/min) for two
      minutes. Subsequently, 0.5 mg/kg propofol was administered via IV route and, 0.5 mg/kg
      rocuronium was administered via IV route at the time eyelash reflex disappeared. Intubation
      was performed after two minutes. After recording baseline values of heart rate (HR), systolic
      arterial pressure (SBP), diastolic arterial pressure (DBP) and mean arterial pressure (MAP),
      these values were recorded at the 1st, 2nd, 3rd, 4th and 5th minutes of induction.
    

Detailed description: 
      The present study was carried out after the approval of "Dokuz Eylül University School of
      Medicine, Clinical Researches Ethics Committee and informed consents of the patients were
      obtained. A total of 90 normotensive and American Society of Anesthesiology (ASA) I-II
      patients at and over the age of 65 years undergoing elective non-cardiac surgery were
      enrolled in the study. The study was designed as a prospective, randomized, double-blind
      study. The patients were randomly (sealed envelope method) assigned to one of the following
      groups:

      Remi 0.1= dose of remifentanil for the induction of anesthesia is 0.1 µg/kg/min (n=30) Remi
      0.2= dose of remifentanil for the induction of anesthesia is 0.2 µg/kg/min (n=30) Remi 0.3=
      dose of remifentanil for the induction of anesthesia is 0.3 µg/kg/min (n=30) The patients and
      the anesthesiologist, who would perform the induction of anesthesia, were blind for
      remifentanil dose.

      In all patients, an intravenous (IV) line was opened on the dorsum of the left hand using
      18-Gauge cannula before they were admitted to the surgery room and 0.9% isotonic NaCl
      solution was infused at a dose of 5-7 mL/kg without any agent for premedication. The patients
      underwent standard monitoring composed of electrocardiogram (ECG), pulse oximeter,
      noninvasive blood pressure measurement, and end tidal carbon dioxide measurement. After
      5-minute stabilization period following monitoring, heart rates and systemic arterial
      pressures of the patients were measured and baseline values were recorded for each patient
      (6). Measurement of systemic arterial pressure was done by automatic oscillometry
      (Hewlett-Packard HP M1008B) and heart rate (HR) was calculated on the ECG trace
      (Hewlett-Packard HP M1002A). Induction of Anesthesia Following routine monitoring in the
      surgery room, induction of anesthesia was started after the patients were peroxygenized and
      received 0.9% isotonic NaCl solution via IV route at a dose of 5-7 mL/kg. Following
      intravenous (IV) administration of 0.5 mg Atropine (Atropin, Biofarma, Istanbul, Turkey)
      prior to the induction, the patients randomly (by lot) received one of the three different
      doses (0.1, 0.2, 0.3 µg/kg/min) of remifentanil infusion (Ultiva, Glaxo Wellcome,
      Marly-le-Roi, France) for two minutes. After 2-minute remifentanil infusion (remi
      concentration of 40 µg/mL), 0.5 mg/kg propofol ( Propofol 1% Fresenius; Fresenius Kabi,
      Uppsala, Sweden) was administered via IV route increasing the dose by 10 mg every 10 seconds;
      0.5 mg/kg rocuronium was administered via IV route at the time of loss of eyelash reflex and
      consciousness (7). Two minutes later, intubation was performed at one sitting in all patients
      by a specialist with at least 5-year experience using Macintosh laryngoscope. The lungs were
      manually ventilated by sevoflurane at an inspiratory concentration of 1.5% and by 50%
      air/oxygen until the intubation. Infusion dose of remifentanil, which had been performed at
      induction dose until intubation, was decreased by 50% in all groups after intubation.

      The maintenance of anesthesia was provided with remifentanil at predetermined dose and the
      ventilation continued with 50% air/oxygen and sevoflurane at an inspiratory concentration of
      1.5% in the way target end-tidal carbon dioxide value would be 30-35 mmHg.

      After recording the baseline values of heart rate, systolic arterial pressure, mean arterial
      pressure and diastolic arterial pressure, which were planned to be investigated, and
      administering atropine, a total of six measurements at one-minute intervals were performed
      until the time of intubation; no measurement was performed during intubation period.

      Hypotension was defined as a systolic arterial pressure < 90 mmHg or a decrease more than 30%
      of the baseline value, and it was treated with 5 mg IV Ephedrine (Efedrin, Osel, Istanbul,
      Turkey) (8). Determining 40% or higher decrease in the above-mentioned values, the dose of
      remifentanil infusion was decreased by 50% in addition to administration of 5 mg IV
      Ephedrine; in case no improvement was observed and systolic arterial pressure remained below
      40% of the baseline value, the dose of remifentanil was decreased by 1/4. A heart rate <
      50/min was defined as bradycardia and treated with 0.5 mg IV Atropine.
    

Intervention name(s): Remi 0.1; Remi 0.2; Remi 0.3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous (IV) administration of 0.5 mg Atropine prior to the induction, the patients randomly (by lot) received one of the three different doses (0.1 µg/kg/min) of remifentanil infusion for two minutes.After 2-minute remifentanil infusion, 0.5 mg/kg propofol was administered via IV route increasing the dose by 10 mg every 10 seconds; 0.5 mg/kg rocuronium was administered via IV route at the time of loss of eyelash reflex and consciousness. Two minutes later, intubation was performed. After recording the baseline values of heart rate, systolic arterial pressure, mean arterial pressure and diastolic arterial pressure, which were planned to be investigated, and administering atropine, a total of six measurements at one-minute intervals were performed until the time of intubation.; .Intravenous (IV) administration of 0.5 mg Atropine prior to the induction, the patients randomly (by lot) received one of the three different doses (0.2 µg/kg/min) of remifentanil infusion for two minutes.After 2-minute remifentanil infusion, 0.5 mg/kg propofol was administered via IV route increasing the dose by 10 mg every 10 seconds; 0.5 mg/kg rocuronium was administered via IV route at the time of loss of eyelash reflex and consciousness. Two minutes later, intubation was performed. After recording the baseline values of heart rate, systolic arterial pressure, mean arterial pressure and diastolic arterial pressure, which were planned to be investigated, and administering atropine, a total of six measurements at one-minute intervals were performed until the time of intubation.; Intravenous (IV) administration of 0.5 mg Atropine prior to the induction, the patients randomly (by lot) received one of the three different doses (0.3 µg/kg/min) of remifentanil infusion for two minutes.After 2-minute remifentanil infusion, 0.5 mg/kg propofol was administered via IV route increasing the dose by 10 mg every 10 seconds; 0.5 mg/kg rocuronium was administered via IV route at the time of loss of eyelash reflex and consciousness. Two minutes later, intubation was performed. After recording the baseline values of heart rate, systolic arterial pressure, mean arterial pressure and diastolic arterial pressure, which were planned to be investigated, and administering atropine, a total of six measurements at one-minute intervals were performed until the time of intubation.
Other intervention name(s): remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi, France; remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi, France; remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi,
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: cardiovascular responses; analgesics opioid; remifentanil