A study to compare intranasal Dexmedetomidine versus magnesium sulphate as an atomiser on attenuation of haemodynamic stress response to laryngoscopy under general anaesthesia. Objective is to study the comparison between Dexmedetomidine and magnesium sulphate that how well it reduces heart rate and blood pressure when given intranasally via atomiser during laryngoscopy under general anaesthesia , to study post operative Ramsay sedation score and to observe if there are any side effects of the given drug.
Inclusion criteria Patients willing to sign written and informed consent, male or female patients between 18 to 65 years of age, patients belonging to American Society of Anaesthesiologists(ASA) physical status I and II, patients posted for elective surgeries under general anaesthesia.
Exclusion criteria Patients unwilling to participate in study, patients with Body Mass Index greater than 30 Kg per metre square, patients having arrythmias, patient having heart rate less than 70 beats per minute, psychiatric patients, pregnancy and lactating women, patients belonging to the American Society of Anaesthesiologists (ASA) III and above, patients allergic to the study drugs, serum magnesium level greater than 2.5 meq per litre.
The study will be conducted on 56 adults aged 18 to 60 yrs belonging to grade I & II of American Society of Anesthesiologists (ASA) classification who will undergo elective surgeries under general anesthesia. They will be divided into 2 equal groups with chit method. Group D will recieve dexmedtomidine 2 mcg per kg in 2ml 0.9 percent NS and Group M will recieve magnesium sulphate 1000mg in 2ml 0.9 percent NS through atomiser 30 minutes before induction by consultant anaesthesiologist. After completion of atomisation following vitals will be observed : Heart Rate (HR) , Systolic Blood Pressure (SBP) , Diastolic Blood Pressure (DBP) , Mean Arterial Pressure (MAP), SpO2 at baseline (Tb) , after test drug administration (Td), during induction (Ti), during laryngoscopy and intubation (T0) , at 1 , 3 , 5 , 7 and 10 mintues after intubation (T1), (T3), (T5), (T7), (T10) respectively. Post operatively sedation status will be assessed half hourly by RAMSAY Sedation Score (RSS) till a score of 2 is achieved.
Site of Study Department of Anesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara
Study Design Prospective, double blinded and comparative study.
Study Duration The study will be initiated after obtaining permission from institutional ethics committee till the achievement of the sample size or by 18 months whichever is earlier.
Statistics Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student-t test and/or ANNOVA will be used wherever appropriate for between-groups comparisons, while for categorical variables; chi-square test will be used. P value less than 0.05 will be considered statistically significant.
Likely outome This prospective and comparative study will help us to compare the efficacy between intranasal Dexmedetomidine and magnesium sulphate via atomiser in attenuating hemodynamic responses to laryngoscopy in patients undergoing surgeries under general anesthesia by having better outcome in hemodynamics. |