Comparison of nebulised Fentanyl and different doses of nebulised Dexmedetomidine in attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation in patients undergoing nasal surgery : A randomised double blind controlled trial

A prospective, randomized controlled trial will be conducted on 90 patients of ASA I and II undergoing elective nasal surgeries under general anaesthesia, between age group of 18-65 years in KIMS Hubballi. Patients will be enrolled for the study and randomly allocated into 3 groups as per computer generated table.

GROUP A (n=30): Patients who will receive nebulisation dexmedetomidine 1 ug/kg 10min before induction

GROUP B (n=30):Patients who will receive nebulisation dexmedetomidine 1.5 ug/kg 10min before induction .

GROUP C (n=30):Patients who will receive nebulization fentanyl 1ug/kg 10min before induction .

Pre-operative data will be collected prospectively for all patients undergoing nasal surgeries requiring general anaesthesia in our institution. All patients who meet the inclusion criteria, will undergo pre-anaesthetic evaluation a day prior to surgery. Height and weight of the patient will be noted. Informed valid written consent will be taken from all patients. Patients will be kept nil by mouth for solid food for 8 hours and clear liquids for 2 hours before surgery. Patients will be shifted to preoperative room on the day of surgery . Prenebulisation monitors will be connected HR ,SBP,DBP,MAP will be recorded . Preoperative anxiety will be assesed using APAIS in all the 3 groups . Patients according to the the group allocated will recieve nebulisation. The nebulization solution will be prepared by anaesthsiology resident not involved in making observations and the observer anaesthesiologist will be blinded. 10 min after the nebulisation anxiety and sedation will be assesed using RSS. Patients will be wheeled into the operation theatre and monitors will be attached (electrocardiography, non-invasive blood pressure, Oxygen saturation and heart rate) and baseline values of HR, SBP, DBP, MAP and SPO2 will be recorded.18 G IV cannula will be secured in the non-dominant upper limb of patient and Ringer lactate infusion will be started and patient will be briefed about the procedures to be performed. Patients premedicated with inj. glycopyrrolate 0.004mg/kg inj. midazolam 0.05 mg/kg and inj. Fentanyl 2mcg/kg i.v. After 3 minutes of preoxygenation, anaesthesia will be induced with Inj. Propofol 2 mg/kg i.v. and vecuronium bromide 0.1mg/kg will be given intravenously. Endotracheal intubation will be carried out after 3 minutes, with appropriate sized cuffed endotracheal tube (ETT) using Macintosh laryngoscope. Anaesthesia will be maintained with oxygen and nitrous oxide (50:50), intermittent vecuronium and sevoflurane. Minute ventilation will be adjusted to maintain normocapnia (etCO2 between 35 and 40 mmHg). During procedure HR, SBP , DBP , MAP will be recorded at 1 , 5, 10 min post intubation . All patients will receive infilteration on the nasal mucosa with 2% Lignocaine with adrenaline by the operating surgeon 15 minutes post intubation as is usually administered by the surgeons for nasal surgeries to achieve reduced blood loss and also analgesia.

At the end of the surgery, the inhalational anaesthetics used for maintenance of anaesthesia will be stopped . The HR, SBP, DBP and MAP values will be recorded. The muscle relaxation will be reversed with injection neostigmine 0.05mg/kg IV and glycopyrrolate 0.01 mg/kg .

Occurrence of any adverse events will be recorded. Hypotension is defined as fall in SBP<80 mmHg and bradycardia is defined as fall in HR<50 beats per minute. Hemodynamic fluctuations will be managed accordingly. Ondansetron (4 mg IV) will be administered on complaint of nausea and vomiting.

All patients will be administered inj paracetomol 20mg/kg post operatively TID for maintaining adequate analgesia .Patients will be assesed for post operative pain using VAS ( Visual Analog Scale) and RSS at 0,1, 3 , 6 , 12 hrs after the surgery.Any adverse events will be recorded and treated accordingly.