Esmolol Versus Dexmedetomidine During Intracranial Procedures

Intracranial Aneurysm Clinical Trial

Official title:

Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02563288
• Other study ID #: GeorgePapanikolaouHospital
• Status: Recruiting
• Phase: Phase 3
• First received: September 19, 2015
• Last updated: July 25, 2017
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2017
• Source: George Papanicolaou Hospital
• Contact: Irene Asouhidou, MD, PhD
• Email: iasouh[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Brain Neoplasms
• Intracranial Aneurysm
• Intracranial Neoplasms

Intervention

Drug:
• Esmolol
effect of esmolol on intraoperative sympathetic control and on extubation conditions.
• Dexmedetomidine
effect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions.

Locations

Country	Name	City	State
Greece	George Papanikolaou General Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
George Papanicolaou Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Grillo 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):1145-9, table of contents. — View Citation

Tanskanen PE, Kyttä 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. Epub 2006 Aug 16. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic arterial pressure- mean arterial pressure (mmHg)	Status of patients during emerge from anaesthesia after intracranial surgery	every 15minutes, starting from the induction in anesthesia through surgery completion and up to first 24 postoperative hours.