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Completed

NCT Number: NCT02455440

Esmolol Infusion in Patients Undergoing Craniotomy

Anesthesia techniques that minimize anesthetic requirements and their effects may be beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in blunting adrenergic response to several perioperative stimuli and so it might interfere in the effect of the anesthetic drugs on the brain. This study was designed to investigate the effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing craniotomy.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

George Papanikolaou General Hospital

Thessaloniki, 55133, Greece

About this study

Patients undergoing elective craniotomy for aneurysm clipping or tumor dissection were randomly divided in two groups (four subgroups). Anesthesia was induced with propofol, fentanyl and a single dose of cis-atracurium, followed by continuous infusion of remifentanil and either propofol or sevoflurane. Patients in the esmolol group received 500 mcg/kg of esmolol bolus 10 min before induction of anesthesia, followed by additional 200 mcg/kg/min of esmolol. Monitoring of the depth of anesthesia was also performed using the Bispectral Index-BIS. It was also performed monitoring of the cardiac output in order to evaluate the effect of esmolol on cardiac output.

The inspired concentration of sevoflurane and the infusion rate of propofol were adjusted in order to maintain a BIS value between 40-50.

Intraoperative emergence was detected by the elevation of BIS value, HR or MAP.

It was recorded intraoperative fluctuations of propofol and sevoflurane in both groups. Data were expressed as mean ± SD. Differences in categorical data were evaluated using the student t test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ASA physical status 1-3
  • Glasgow Coma Scale:15

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,
  • chronic use of b-blocker,
  • Glasgow Coma Scale (GCS) <15,
  • history of drug abuse,
  • severe mental impairment,
  • preoperative aphasia,
  • neurologic deficit or preoperatively foreseen delayed extubation.

Treatment and study plan

esmolol

Drug

effect of esmolol on intraoperative fluctuations of propofol and sevoflurane. Propofol and sevoflurane intraoperative concentration will be expressed as mean ± SD. Differences in categorical data will be evaluated using the student t test.

Other names: propofol, sevoflurane

Placebo

Drug

Propofol and sevoflurane

Drug

Primary outcomes

  1. systolic arterial pressure fluctuation

    Time frame: intraoperative

Secondary outcomes

  1. extubation time

    Time frame: at time of surgery

  2. Heart rate

    Time frame: intraoperative

  3. effect of esmolol on anesthetic's concentration

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

George Papanicolaou Hospital

Other

Registry information

Official study title

Esmolol Reduces Anesthetic Requirements Thereby Facilitating Early Extubation; a Prospective Controlled Study in Patients Undergoing Intracranial Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 27, 2015
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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