TachycardiaPhase 4NCT01628562
A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery
A Phase 4 study testing Esmolol and Remifentanil in people with Tachycardia and Hypertension, run by Diskapi Teaching and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Tachycardia, Hypertension, Myocardial Ischemia
- What is being tested?
- Esmolol and Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jun 2012to Sep 2014
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intracranial surgery
Who cannot join
- heart rate ≤ 50,
- atrioventricular block,
- sick sinus syndrome,
- heart failure,
- history of asthma,
- hypertension,
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- impaired renal or hepatic function,
- patients receiving beta blockers or calcium channel blockers,
- emergency surgery.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, Turkey, 06610
Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, 06610
About this study
Official title: A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol: a Double Blind Randomized Controlled Study
It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. It was the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes were the secondary objectives.
Read the detailed description
During neurosurgical procedures intubation, insertion of the head pins, extubation and the early postoperative period are the time lines in which cerebral autoregulation can be impaired by changes in heart rate and blood pressure. Several anesthetic regimens have been implied to overcome this problem. Remifentanil is used in neurosurgery since it allows early recovery and neurologic evaluation. Esmolol on the other hand is also very short acting, effective to blunt cardiovascular responses during surgery and has no significant effect on intracranial pressure and cerebral blood flow. In addition esmolol is addressed to reduce perioperative ischemia during noncardiac surgery.
It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. It was the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes were the secondary objectives.
- Conditions
- Tachycardia, Hypertension, Myocardial Ischemia
- Being tested
- Esmolol, Remifentanil
- Keywords
- Remifentanil, Esmolol, Intracranial surgery, Heart rate, Blood pressure
- Medical subject headings
- Tachycardia, Hypertension, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
Also called Brevibloc
Esmolol 50 mcg/kg/min
RemifentanilDrug
Also called Ultiva
Remifentanil 0.5 mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| GroupE/Esmolol infusion | Active comparator | Heart rate control, Beta blocker Receives: Drug: Esmolol |
| GroupR/Remifentanil infusion | Experimental | Heart rate control, opioid Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
It is the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension
Measured: during intubation, head pin insertion, extubation, early postoperative period
Secondary outcomes (1)
the intraoperative fentanyl consumption
Measured: during intubation, head pin insertion, extubation, early postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TachycardiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Dilek Yazicioglu, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628562
- Sponsor's protocol ID
- Dilek Esmolol
- Status last verified
- Dec 2012
- First submitted
- 28 May 2012
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heinke W, Zysset S, Hund-Georgiadis M, Olthoff D, von Cramon DY. The effect of esmolol on cerebral blood flow, cerebral vasoreactivity, and cognitive performance: a functional magnetic resonance imaging study. Anesthesiology. 2005 Jan;102(1):41-50. doi: 10.1097/00000542-200501000-00010.
PubMed 15618785Landoni G, Turi S, Biondi-Zoccai G, Bignami E, Testa V, Belloni I, Cornero G, Zangrillo A. Esmolol reduces perioperative ischemia in noncardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2010 Apr;24(2):219-29. doi: 10.1053/j.jvca.2009.07.008. Epub 2009 Oct 2.
PubMed 19800816
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol: a Double Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01628562
- Acronym / sponsor ID
- Dilek Esmolol
- Conditions
- Tachycardia, Hypertension, Myocardial Ischemia
- Keywords
- Remifentanil, Esmolol, Intracranial surgery, Heart rate, Blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Jun 2012 (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.
It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. It was the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes were the secondary objectives.
Detailed description
During neurosurgical procedures intubation, insertion of the head pins, extubation and the early postoperative period are the time lines in which cerebral autoregulation can be impaired by changes in heart rate and blood pressure. Several anesthetic regimens have been implied to overcome this problem. Remifentanil is used in neurosurgery since it allows early recovery and neurologic evaluation. Esmolol on the other hand is also very short acting, effective to blunt cardiovascular responses during surgery and has no significant effect on intracranial pressure and cerebral blood flow. In addition esmolol is addressed to reduce perioperative ischemia during noncardiac surgery.
It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. It was the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes were the secondary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GroupE/Esmolol infusion | Active comparator | Drug: EsmololHeart rate control, Beta blocker |
| GroupR/Remifentanil infusion | Experimental | Drug: RemifentanilHeart rate control, opioid |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Intracranial surgery
Key exclusion criteria (9 listed)
- heart rate ≤ 50,
- atrioventricular block,
- sick sinus syndrome,
- heart failure,
- history of asthma,
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 |
|---|---|---|
| EsmololAlso: BreviblocEsmolol 50 mcg/kg/min | Drug | GroupE/Esmolol infusion |
| RemifentanilAlso: UltivaRemifentanil 0.5 mcg/kg/min | Drug | GroupR/Remifentanil infusion |
Primary outcome
It is the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension
Time frame: during intubation, head pin insertion, extubation, early postoperative period
1 secondary outcome
the intraoperative fentanyl consumption
Time frame: during intubation, head pin insertion, extubation, early postoperative period
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 18 Feb 2015.
- Background: PubMed 15618785Heinke W, Zysset S, Hund-Georgiadis M, Olthoff D, von Cramon DY. The effect of esmolol on cerebral blood flow, cerebral vasoreactivity, and cognitive performance: a functional magnetic resonance imaging study. Anesthesiology. 2005 Jan;102(1):41-50. doi: 10.1097/00000542-200501000-00010.
- Background: PubMed 19800816Landoni G, Turi S, Biondi-Zoccai G, Bignami E, Testa V, Belloni I, Cornero G, Zangrillo A. Esmolol reduces perioperative ischemia in noncardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2010 Apr;24(2):219-29. doi: 10.1053/j.jvca.2009.07.008. Epub 2009 Oct 2.
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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.
Dilek Yazicioglu principal investigator
MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esmolol and Remifentanil in people with Tachycardia and Hypertension, run by Diskapi Teaching and Research Hospital at 2 sites in Turkey (Türkiye).
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 1 inclusion and 9 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 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
It is the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension (time frame: during intubation, head pin insertion, extubation, early postoperative period). 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 NCT01628562, which also lists 2 linked publications.
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 18 Feb 2015.