Role of Preemptive Chlorepheniramine Maleate in Reducing Postoperative Agitation After Functional Endoscopic Sinus Surgeries (FESS)

A total of 90 adult patients undergoing FESS procedure for sinusitis with postoperative nasal packing. Written informed consent will be obtained from all patients before randomization. Patients will be divided equally into two groups the first 45 patients will be assigned to chlorepheniramine maleate group (A) and the other group to placebo group (B). Group assignment, preparation and administration of drugs will be performed by a junior anesthetist who is neither involved nor interested by any means in the study. Blind grouping will be kept to all including the patients themselves, until the completion of study.

Inclusion and Exclusion Criteria The inclusion criteria of these patients include adult patients (age 18- 60 years), class I-II according to American society of anaesthesiologists (ASA) physical status subjected to FESS without septoplasty. Exclusion criteria include; patients below 18 years old or over 60 years old, patients with ASA physical status class III-IV, morbid obesity with BMI > 30 kgm-2 at initial hospital visit, history of neuro-psychatric ailment or chronic use of antipsychotic drugs, severe cardiovascular disease, any coagulopathies, pregnancy, history of relevant drug allergy, any possibility of anticipated difficult intubation.

Preoperative Anesthetic Assessment All patients will be subjected to a thorough medical history, physical examination, laboratory investigations (fasting blood sugar, kidney, liver function tests, serum electrolytes, coagulation profile, and electrocardiogram) preoperatively. They will be also counseled about the anesthetic management and potential complications of both surgery and anesthesia, and the explanations of numerical pain analogue scale (NAS) from 0-10. All these data will be documented. A thorough airway assessment by Mallampati classification, mouth opening, neck movement, thyromental distance will be done to find out any possibility of difficult intubation. If there is a chance of significant difficult intubation, the patient will be excluded from the study.

Anesthetic Protocol All patients admitted to OR induction area where patient identification is confirmed and an 18-gauge intravenous cannula will be inserted to all Participants. Participants of group A will receive only one ampoule of 45.5 mg/ 2mL chlorepheniramine maleate diluted in 8 ml isotonic saline intravenous (I.V) prior to induction of general anesthesia by 30 minutes while participants in group (B) will receive 10 ml isotonic saline (placebo) by the same route as control.

General anesthesia will be started for all patients with intravenous lignocaine 1.0 mg/kg, propofol 2.0 mg/kg, then atracurium 0.5 mg/kg, fentanyl 1 µg/kg then they will be intubated orally which is fixed after confirmation of its place by auscultation then oral packing with wet gauze under vision using laryngoscope. Anesthesia will be maintained by mixture of O2 and air along with 2% sevoflurane then atracurium 0.1 mg/kg will be given for maintenance of muscle relaxation.. All patients will be monitored by standard monitors including, the pulse oximeter, non-invasive blood pressure, end-tidal C02, and electrocardiogram. Moreover, bispectral index monitor is used to assess depth of general anesthesia.