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Remifentanil on Hemodynamic Response to Anesthesia Induction

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ClinicalTrials.gov Identifier: NCT02763098
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Nilay Boztas,MD, Dokuz Eylul University

Brief 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.


Condition or disease Intervention/treatment Phase
Anesthesia Drug: Remi 0.1 Drug: Remi 0.2 Drug: Remi 0.3 Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Effects of Different Doses of Remifentanil on Hemodynamic Response to Anesthesia Induction in Elderly Patients
Study Start Date : January 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remi 0.1
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.
Drug: Remi 0.1
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.
Other Name: remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi, France

Experimental: Remi 0.2
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-RoiFrance) for two minutes.
Drug: Remi 0.2
.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.
Other Name: remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi, France

Experimental: Remi 0.3
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.
Drug: Remi 0.3
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 Name: remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi,




Primary Outcome Measures :
  1. Measurement was performed using physiological parameters. After recording baseline values of systolic arterial pressure (SBP), these values were recorded at the 1st, 2nd, 3rd, 4th and 5th minutes of induction. [ Time Frame: Five minutes ]
    Aim to identify the remifentanil dose that we can recommend. To determine hemodynamic changes likely to occur while using three different doses of remifentanil in the induction of anesthesia in the patients at and over the age of 65 years. Physiological parameters; measurement of systemic arterial pressure was done by automatic oscillometry (Hewlett-Packard HP M1008B).

  2. Measurement was performed using physiological parameters. After recording baseline values of diastolic arterial pressure (DBP), these values were recorded at the 1st, 2nd, 3rd, 4th and 5th minutes of induction. [ Time Frame: Five minutes ]
    Aim to identify the remifentanil dose that we can recommend. To determine hemodynamic changes likely to occur while using three different doses of remifentanil in the induction of anesthesia in the patients at and over the age of 65 years. Physiological parameters; measurement of diastolic arterial pressure was done by automatic oscillometry (Hewlett-Packard HP M1008B).

  3. Measurement was performed using physiological parameters. After recording baseline values of mean arterial pressure (MBP), these values were recorded at the 1st, 2nd, 3rd, 4th and 5th minutes of induction. [ Time Frame: Five minutes ]
    Aim to identify the remifentanil dose that we can recommend. To determine hemodynamic changes likely to occur while using three different doses of remifentanil in the induction of anesthesia in the patients at and over the age of 65 years. Physiological parameters; measurement of mean arterial pressure was done by automatic oscillometry (Hewlett-Packard HP M1008B).

  4. Measurement was performed using physiological parameters. After recording baseline values of heart rate (HR), these values were recorded at the 1st, 2nd, 3rd, 4th and 5th minutes of induction. [ Time Frame: Five minutes ]
    Aim to identify the remifentanil dose that we can recommend. To determine hemodynamic changes likely to occur while using three different doses of remifentanil in the induction of anesthesia in the patients at and over the age of 65 years. Physiological parameters; measurement of heart rate was calculated on the ECG trace (Hewlett-Packard HP M1002A).



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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normotensive patients
  • ASA I-II
  • Patients over the age of 65 years
  • Undergoing elective non-cardiac surgery

Exclusion Criteria:

  • Patients who had allergy against opioids
  • Chronic benzodiazepine, opioid, alcohol or substance users
  • Obese (body mass index > 30)
  • Expected to have difficult airway
  • Patients had hypertension
  • Patients have been receiving any drug influencing the cardiovascular system (beta -adrenergic blocker, calcium channel blocker, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763098


Sponsors and Collaborators
Dokuz Eylul University
Investigators
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Principal Investigator: Nilay Boztas, MD Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation Inciraltı IZMIR 35320

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nilay Boztas,MD, MD, Consultant, Dept of Anesthesiology and Reanimation, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT02763098     History of Changes
Other Study ID Numbers: 2012/25-04
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Nilay Boztas,MD, Dokuz Eylul University:
cardiovascular responses
analgesics opioid
remifentanil

Additional relevant MeSH terms:
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Remifentanil
Atropine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action