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Esmolol Versus Dexmedetomidine During Intracranial Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563288
Recruitment Status : Unknown
Verified July 2017 by Asouhidou Irene, George Papanicolaou Hospital.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Asouhidou Irene, George Papanicolaou Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Intracranial Neoplasms Drug: Esmolol Drug: Dexmedetomidine Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Esmolol
Esmolol 500mcg/kg before induction in anesthesia following by 300mcg/Kg/min until extubation.
Drug: Esmolol
effect of esmolol on intraoperative sympathetic control and on extubation conditions.
Other Name: b adrenergic antagonist

Active Comparator: Dexmedetomidine
Dexmedetomidine 1mcg/Kg following by 0.7mcg/Kg/h until end of surgery.
Drug: Dexmedetomidine
effect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions.
Other Name: alpha adrenergic agonist




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ASA physical status 1-3
  • Glasgow Coma Scale:13-15
  • Hunt-Hess: 0-3

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563288


Contacts
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Contact: Irene Asouhidou, MD, PhD iasouh@aol.com
Contact: Dimitris Zosimidis, MD d.zosimidis@gmail.com

Locations
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Greece
George Papanikolaou General Hospital Recruiting
Thessaloniki, Greece, 55133
Contact: Irene Asouhidou, MD, PhD    00302310452560    iasouh@aol.com   
Sponsors and Collaborators
George Papanicolaou Hospital

Publications of Results:
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Responsible Party: Asouhidou Irene, Consultant anesthesiologist, George Papanicolaou Hospital
ClinicalTrials.gov Identifier: NCT02563288    
Other Study ID Numbers: GeorgePapanikolaouHospital
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Asouhidou Irene, George Papanicolaou Hospital:
esmolol
dexmedetomidine
opioids
Additional relevant MeSH terms:
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Brain Neoplasms
Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Dexmedetomidine
Adrenergic Agents
Esmolol
Adrenergic Agonists
Adrenergic Antagonists
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action