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Report for Clinical Trial NCT02763098

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Effects of Different Doses of Remifentanil on Hemodynamic Response to Anesthesia Induction in Elderly Patients

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.

NCT02763098 Anesthesia

3 Interventions

Name: Remi 0.1

Description: 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.

Type: Drug

Remi 0.1

Name: Remi 0.2

Description: .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.

Type: Drug

Remi 0.2

Name: Remi 0.3

Description: 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.

Type: Drug

Remi 0.3


Primary Outcomes

Description: 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).

Measure: 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: Five minutes

Description: 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).

Measure: 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: Five minutes

Description: 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).

Measure: 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: Five minutes

Description: 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).

Measure: 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: Five minutes

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M1002A

Physiological parameters; measurement of heart rate was calculated on the ECG trace (Hewlett-Packard HP M1002A).. 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.) 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.) Anesthesia 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. --- M1002A ---

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). --- M1002A ---



HPO Nodes