Intracranial AneurysmPhase 3NCT02563288
Esmolol Versus Dexmedetomidine During Intracranial Procedures
A Phase 3 study testing Esmolol and Dexmedetomidine in people with Intracranial Aneurysm and Intracranial Neoplasms, run by George Papanicolaou Hospital at 1 site in Greece.
Trial summary
Patients undergoing intracranial procedures may experience severe hypertension and tachycardia due to intracranial hypertension and to increased release of adrenaline. Preventing perioperative sympathetic activity is of great importance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm, Intracranial Neoplasms
- What is being tested?
- Esmolol and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Aug 2016to Oct 2017
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA physical status 1-3
- Glasgow Coma Scale:13-15
- Hunt-Hess: 0-3
Who cannot join
- Patients with ASA physical status >3,
- Body Mass Index (BMI) over 30,
- indication for rapid sequence induction,
- any contraindication for receiving b-blocker,
- Glasgow Coma Scale (GCS) <13,
- history of drug abuse,
- neurologic deficit or preoperatively foreseen delayed extubation,
- preoperative heart rate<45.
Trial locations and contacts
1 site in 1 country.
Irene Asouhidou, MD, PhD contact
Dimitris Zosimidis, MD contact
Greece1 site, 1 recruiting
- Recruiting
George Papanikolaou General Hospital
Thessaloniki, 55133
Irene Asouhidou, MD, PhD, 00302310452560, iasouh@aol.com
About this study
Official title: Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures
Patients undergoing intracranial procedures may experience severe hypertension and tachycardia due to intracranial hypertension and to increased release of adrenaline. Preventing perioperative sympathetic activity is of great importance. A common technique is using b-blockers like esmolol, which effectively block perioperative hemodynamic changes during intracranial surgery. A2 agonists, like Dexmedetomidine-Dex are now being used as a component of a balanced anesthesia during neurosurgical procedures. This study aimed to evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing elective craniotomy with fast track neuroanesthesia.
Read the detailed description
Patients scheduled for elective craniotomy are randomized to receive Dex 1γ/Kg over 10 minutes following by continuous infusion of Dex 0.7γ/Kg (group D) or esmolol 500mcg/Kg over 5 min following by continuous infusion of 300mcg/Kg/min (group E). Patients in both groups are subjected to a standardized anesthesia comprising of induction with propofol, fentanyl, rocuronium, and maintained with Oxygen-air: 1/1, sevoflurane and bolus fentanyl in order to access the same level of anesthesia (BIS 40-50). The hemodynamic variables at various stages of surgery (HR-heart rate, MAP-Mean arterial pressure) and recovery characteristics are also recorded. It is also performed monitoring of cerebral oximetry (INVOS).
- Conditions
- Intracranial Aneurysm, Intracranial Neoplasms
- Being tested
- Esmolol, Dexmedetomidine
- Keywords
- esmolol, dexmedetomidine, opioids
- Medical subject headings
- Intracranial Aneurysm, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
Also called b adrenergic antagonist
effect of esmolol on intraoperative sympathetic control and on extubation conditions.
DexmedetomidineDrug
Also called alpha adrenergic agonist
effect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions.
| Study group | Role | What they receive |
|---|---|---|
| Esmolol | Active comparator | Esmolol 500mcg/kg before induction in anesthesia following by 300mcg/Kg/min until extubation. Receives: Drug: Esmolol |
| Dexmedetomidine | Active comparator | Dexmedetomidine 1mcg/Kg following by 0.7mcg/Kg/h until end of surgery. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic arterial pressure- mean arterial pressure (mmHg)
Status of patients during emerge from anaesthesia after intracranial surgery
Measured: every 15minutes, starting from the induction in anesthesia through surgery completion and up to first 24 postoperative hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionOct 2017 (estimated)
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 Intracranial AneurysmStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Papanicolaou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asouhidou Irene, George Papanicolaou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563288
- Sponsor's protocol ID
- GeorgePapanikolaouHospital
- Status last verified
- Jul 2017
- First submitted
- 19 Sep 2015
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tanskanen PE, Kytta JV, Randell TT, Aantaa RE. Dexmedetomidine as an anaesthetic adjuvant in patients undergoing intracranial tumour surgery: a double-blind, randomized and placebo-controlled study. Br J Anaesth. 2006 Nov;97(5):658-65. doi: 10.1093/bja/ael220. Epub 2006 Aug 16.
PubMed 16914460Grillo P, Bruder N, Auquier P, Pellissier D, Gouin F. Esmolol blunts the cerebral blood flow velocity increase during emergence from anesthesia in neurosurgical patients. Anesth Analg. 2003 Apr;96(4):1145-1149. doi: 10.1213/01.ANE.0000055647.54957.77.
PubMed 12651674
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures
- ClinicalTrials.gov ID
- NCT02563288
- Acronym / sponsor ID
- GeorgePapanikolaouHospital
- Conditions
- Intracranial Aneurysm, Intracranial Neoplasms
- Keywords
- esmolol, dexmedetomidine, opioids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- George Papanicolaou HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 30 Sep 2015 (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.
Patients undergoing intracranial procedures may experience severe hypertension and tachycardia due to intracranial hypertension and to increased release of adrenaline. Preventing perioperative sympathetic activity is of great importance. A common technique is using b-blockers like esmolol, which effectively block perioperative hemodynamic changes during intracranial surgery. A2 agonists, like Dexmedetomidine-Dex are now being used as a component of a balanced anesthesia during neurosurgical procedures. This study aimed to evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing elective craniotomy with fast track neuroanesthesia.
Detailed description
Patients scheduled for elective craniotomy are randomized to receive Dex 1γ/Kg over 10 minutes following by continuous infusion of Dex 0.7γ/Kg (group D) or esmolol 500mcg/Kg over 5 min following by continuous infusion of 300mcg/Kg/min (group E). Patients in both groups are subjected to a standardized anesthesia comprising of induction with propofol, fentanyl, rocuronium, and maintained with Oxygen-air: 1/1, sevoflurane and bolus fentanyl in order to access the same level of anesthesia (BIS 40-50). The hemodynamic variables at various stages of surgery (HR-heart rate, MAP-Mean arterial pressure) and recovery characteristics are also recorded. It is also performed monitoring of cerebral oximetry (INVOS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esmolol | Active comparator | Drug: EsmololEsmolol 500mcg/kg before induction in anesthesia following by 300mcg/Kg/min until extubation. |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineDexmedetomidine 1mcg/Kg following by 0.7mcg/Kg/h until end of surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ASA physical status 1-3
- Glasgow Coma Scale:13-15
- Hunt-Hess: 0-3
Key exclusion criteria (8 listed)
- Patients with ASA physical status >3,
- Body Mass Index (BMI) over 30,
- indication for rapid sequence induction,
- any contraindication for receiving b-blocker,
- Glasgow Coma Scale (GCS) <13,
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: b adrenergic antagonisteffect of esmolol on intraoperative sympathetic control and on extubation conditions. | Drug | Esmolol |
| DexmedetomidineAlso: alpha adrenergic agonisteffect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions. | Drug | Dexmedetomidine |
Primary outcome
Systolic arterial pressure- mean arterial pressure (mmHg)
Time frame: every 15minutes, starting from the induction in anesthesia through surgery completion and up to first 24 postoperative hours.
Status of patients during emerge from anaesthesia after intracranial surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Results publication: PubMed 16914460Tanskanen PE, Kytta JV, Randell TT, Aantaa RE. Dexmedetomidine as an anaesthetic adjuvant in patients undergoing intracranial tumour surgery: a double-blind, randomized and placebo-controlled study. Br J Anaesth. 2006 Nov;97(5):658-65. doi: 10.1093/bja/ael220. Epub 2006 Aug 16.
- Results publication: PubMed 12651674Grillo P, Bruder N, Auquier P, Pellissier D, Gouin F. Esmolol blunts the cerebral blood flow velocity increase during emergence from anesthesia in neurosurgical patients. Anesth Analg. 2003 Apr;96(4):1145-1149. doi: 10.1213/01.ANE.0000055647.54957.77.
- Individual participant dataSharing planned: No
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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.
Irene Asouhidou, MD, PhD contact
Dimitris Zosimidis, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esmolol and Dexmedetomidine in people with Intracranial Aneurysm and Intracranial Neoplasms, run by George Papanicolaou Hospital at 1 site in Greece.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Asouhidou, MD, PhD (iasouh@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic arterial pressure- mean arterial pressure (mmHg) (time frame: every 15minutes, starting from the induction in anesthesia through surgery completion and up to first 24 postoperative hours.). 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 NCT02563288, 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 27 Jul 2017.