Ignite Creation Date:
2024-05-06 @ 8:33 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02763098
Status:
COMPLETED
Last Update Posted:
2016-05-05
First Post:
2016-04-13
Brief Title:
Remifentanil on Hemodynamic Response to Anesthesia Induction
Sponsor:
Dokuz Eylul University
Organization:
Dokuz Eylul University
Study Overview
Official Title:
Effects of Different Doses of Remifentanil on Hemodynamic Response to Anesthesia Induction in Elderly Patients
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 01 02 or 03 µgkgmin for two minutes Subsequently 05 mgkg propofol was administered via IV route and 05 mgkg 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
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 01 02 or 03 µgkgmin for two minutes Subsequently 05 mgkg propofol was administered via IV route and 05 mgkg 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 01 dose of remifentanil for the induction of anesthesia is 01 µgkgmin n30 Remi 02 dose of remifentanil for the induction of anesthesia is 02 µgkgmin n30 Remi 03 dose of remifentanil for the induction of anesthesia is 03 µgkgmin n30 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 09 isotonic NaCl solution was infused at a dose of 5-7 mLkg 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 09 isotonic NaCl solution via IV route at a dose of 5-7 mLkg Following intravenous IV administration of 05 mg Atropine Atropin Biofarma Istanbul Turkey prior to the induction the patients randomly by lot received one of the three different doses 01 02 03 µgkgmin of remifentanil infusion Ultiva Glaxo Wellcome Marly-le-Roi France for two minutes After 2-minute remifentanil infusion remi concentration of 40 µgmL 05 mgkg propofol Propofol 1 Fresenius Fresenius Kabi Uppsala Sweden was administered via IV route increasing the dose by 10 mg every 10 seconds 05 mgkg 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 15 and by 50 airoxygen 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 airoxygen and sevoflurane at an inspiratory concentration of 15 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 14 A heart rate 50min was defined as bradycardia and treated with 05 mg IV Atropine
Remi 01 dose of remifentanil for the induction of anesthesia is 01 µgkgmin n30 Remi 02 dose of remifentanil for the induction of anesthesia is 02 µgkgmin n30 Remi 03 dose of remifentanil for the induction of anesthesia is 03 µgkgmin n30 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 09 isotonic NaCl solution was infused at a dose of 5-7 mLkg 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 09 isotonic NaCl solution via IV route at a dose of 5-7 mLkg Following intravenous IV administration of 05 mg Atropine Atropin Biofarma Istanbul Turkey prior to the induction the patients randomly by lot received one of the three different doses 01 02 03 µgkgmin of remifentanil infusion Ultiva Glaxo Wellcome Marly-le-Roi France for two minutes After 2-minute remifentanil infusion remi concentration of 40 µgmL 05 mgkg propofol Propofol 1 Fresenius Fresenius Kabi Uppsala Sweden was administered via IV route increasing the dose by 10 mg every 10 seconds 05 mgkg 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 15 and by 50 airoxygen 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 airoxygen and sevoflurane at an inspiratory concentration of 15 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 14 A heart rate 50min was defined as bradycardia and treated with 05 mg IV Atropine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None