A Study Protocol for Assessing the Effect of Pre-Emptive Oral Clonidine on Intraoperative Hemodynamics and Surgical Field Quality during Functional Endoscopic Sinus Surgery (FESS) under General Anesthesia

Abstract

Background: Typically, endoscopic sinus surgery is reserved for patients with documented rhinosinusitis. The nasal mucosa is impregnated with supply of highly rich blood vessels, so excessive occurrence of bleeding during the procedure may obscure the visibility of the surgical area which might lead into complications. So to control the intraoperative blood loss, controlled hypotension during the surgery can be adopted. Clonidine, a centrally acting α2 agonist has antihypertensive property with decreasing sympathetic outflow. Clonidine given orally judiciously prior to surgery would potentiate the inhalation agents for hypotensive action during the anaesthetic procedure without having the disadvantages of vasodilators given intravenously. This study to assess the effects of clonidine as an oral premedicant in patients who are undergoing Functional Endoscopic Sinus Surgery.
 Methodology: This prospective randomized double blinded placebo controlled study will be conducted in the department of Anaesthesia, Acharya Vinoba Bhave Rural Hospital, (DMIMS) Jawaharlal Nehru Medical College Sawangi Wardha, within the period of time of December 2020 to November 2022. Total 60 patients will be enrolled and randomized in two groups: Group C (n= 30): Patients will be given Clonidine (200 μgm); Group P (n= 30) will be Placebo group. To shrink nasal mucosal vessels, all patients will receive nasal packing of 2% xylocaine with 1:200000 adrenaline. Then, 60 minutes after study drugs are given, patients will be shifted for procedure. Using Six-point Average Category Scale, the grading of surgical field in terms of bleeding, will be done by the operating surgeon. Qualitative data will be documented with the help of percentage table, quantitative data will be presented as mean and standard deviation, student t-test will be taken for comparison among the study groups, Chi-square test will be utilized for comparison of categorical data. SPSS (Statistical Package for Social Sciences) 20.0 version will be the Software used in the analysis and p < 0.05 will be considered significant statistically.
 Expected Results: Oral clonidine when used as premedicant will be effective in reducing bleeding during the procedure of Functional Endoscopic Sinus Surgery.