Esmolol versus Dexmedetomidine for Deliberate Hypotension during Functional Endoscopic Sinus Surgery - Trial PACTR201801002878287

Timeline & Enrollment

Summary

The aim of this study is to compare the hypotensive effect of esmolol and dexmedetomidine during functional endoscopic sinus surgery. After approval of the Ethical Committee at Menoufiya University Hospital, an informed written consent will be obtained from each patient.A pilot study had been carried out. Based on its results, the sample sizing assumed that the expected effect size for the amount of blood loss difference between the 2 groups is 40 ml and the standard deviation of outcome variable is 43. To achieve 80% power to detect this difference with a significance level of 5% it is estimated that 18 subjects per group would be required. With a withdrawal/non-evaluable subject rate of 10% a total of 21 per group subjects will be recruited leading to a total required sample size of 42 subjects. Patients will be randomly allocated into 2 groups, using envelope randomization method. Group E (n = 21) will receive esmolol 1 mg/kg IV over 1 minute, before induction of anesthesia, followed by 150-300 ¿g /Kg/min IV infusion during maintenance, to achieve a target MAP 55-65 mmHg. Group D (n = 21) will receive dexmedetomidine loading dose 1 ¿g/kg IV over 10 minute, before induction of anesthesia, followed by 0.4 ¿ 0.8 ¿g/kg/h IV infusion, during maintenance, to achieve a target MAP 55-65 mmHg.

ICD-10 Classifications