AnesthesiaPhase 4NCT02763098
Remifentanil on Hemodynamic Response to Anesthesia Induction
A Phase 4 study testing Remi 0.1, Remi 0.2 and Remi 0.3 in people with Anesthesia, run by Dokuz Eylul University.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Remi 0.1, Remi 0.2 and Remi 0.3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Normotensive patients
- ASA I-II
- Patients over the age of 65 years
- Undergoing elective non-cardiac surgery
Who cannot join
- 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.)
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Remi 0.1, Remi 0.2, Remi 0.3
- Keywords
- cardiovascular responses, analgesics opioid, remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remi 0.1Drug
Also called remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi, France
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.
Remi 0.2Drug
Also called remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi, France
.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.
Remi 0.3Drug
Also called remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi,
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.
| Study group | Role | What they receive |
|---|---|---|
| Remi 0.1 | Experimental | 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. Receives: Drug: Remi 0.1 |
| Remi 0.2 | Experimental | 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. Receives: Drug: Remi 0.2 |
| Remi 0.3 | Experimental | 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. Receives: Drug: Remi 0.3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: Five minutes
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.
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).
Measured: Five minutes
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.
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).
Measured: Five minutes
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.
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).
Measured: Five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Boztas,MD, Dokuz Eylul University
- Investigators
- Nilay Boztas, MD, Principal investigator, Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation Inciraltı IZMIR 35320
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763098
- Sponsor's protocol ID
- 2012/25-04
- Status last verified
- May 2016
- First submitted
- 13 Apr 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Boztas N, Oztekin S, Ozkardesler S, Akan M, Ozbilgin S, Baytok A. Effects of different doses of remifentanil on hemodynamic response to anesthesia induction in healthy elderly patients. Curr Med Res Opin. 2017 Jan;33(1):85-90. doi: 10.1080/03007995.2016.1239189. Epub 2016 Oct 17.
PubMed 27646937
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Doses of Remifentanil on Hemodynamic Response to Anesthesia Induction in Elderly Patients
- ClinicalTrials.gov ID
- NCT02763098
- Acronym / sponsor ID
- 2012/25-04
- Conditions
- Anesthesia
- Keywords
- cardiovascular responses, analgesics opioid, remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remi 0.1 | Experimental | Drug: Remi 0.1Following 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. |
| Remi 0.2 | Experimental | Drug: Remi 0.2Following 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. |
| Remi 0.3 | Experimental | Drug: Remi 0.3Following 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Normotensive patients
- ASA I-II
- Patients over the age of 65 years
- Undergoing elective non-cardiac surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remi 0.1Also: remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi, FranceIntravenous (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. | Drug | Remi 0.1 |
| Remi 0.2Also: remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi, France.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. | Drug | Remi 0.2 |
| Remi 0.3Also: remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi,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. | Drug | Remi 0.3 |
Primary outcome
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Derived from this study: PubMed 27646937Boztas N, Oztekin S, Ozkardesler S, Akan M, Ozbilgin S, Baytok A. Effects of different doses of remifentanil on hemodynamic response to anesthesia induction in healthy elderly patients. Curr Med Res Opin. 2017 Jan;33(1):85-90. doi: 10.1080/03007995.2016.1239189. Epub 2016 Oct 17.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilay Boztas, MD principal investigator
Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation Inciraltı IZMIR 35320
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remi 0.1, Remi 0.2 and Remi 0.3 in people with Anesthesia, run by Dokuz Eylul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 frame: Five minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02763098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.