Remifentanil on Hemodynamic Response to Anesthesia Induction

NCT02763098 | Completed Phase 4 DMC

• 1 other identifier: 2012/25-04
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Keywords

cardiovascular responses; analgesics opioid; remifentanil

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  Five minutes

Study Arms (3)

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.

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.

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.

Drug: Remi 0.3

Interventions

Remi 0.1 DRUG

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.

Also known as: remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi, France

Remi 0.1

Remi 0.2 DRUG

.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.

Also known as: remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi, France

Remi 0.2

Remi 0.3 DRUG

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.

Also known as: remifentanil, Ultiva, Glaxo Wellcome, Marly-le-Roi,

Remi 0.3

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Dokuz Eylul University: lead

Related Publications (1)

• 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.

  PMID: 27646937 DERIVED

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nilay Boztas, MD

  Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation Inciraltı IZMIR 35320

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Consultant, Dept of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: May 5, 2016
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 5, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share