78.syed rubiya sultana ONLINE.cdr INTRODUCTION Laryngoscopy and intubation is needed for most patients undergoing surgical procedures under general anaesthesia. Hypertension and tachycardia have been commonly associated with intubation under general anesthesia due to manipulation during laryngoscopy and stimulation of epiglottis. Ivabradine is a cardiotonic agent which is highly selective inhibitor of “I ” channels, results in decrease in slope of f spontaneous depolarization leading to increase in time interval between successive action potentials in SA node thereby decreasing the heart rate. Ivabradine reduces the heart rate without compromising hemodynamics, can be used in both hypertensive patients and normotensive patients. MATERIAL AND METHODS After obtaining the clearance from the institutional scientic and ethical commit tee study was undertaken AT Dr.Jeyasekharan Hospital and Nursing Home Nagercoil, Kanyakumari district, Tamilnadu. The study period was 18 months from September 2017 to February 2018 . Pre-anesthetic checkup was done including proper history, general and systemic examination for ASA grading and also for inclusion in the study.90 patients aged above 15 years (ASA I and II) of either sex were selected and they were randomly allocated into two groups as per randomization method. Group A – Comprising 45 patients who received oral ivabradine. Group B – Comprising 45 patients, who received a placebo Written and informed consent were obtained from the patient and standard protocols followed for anesthesia in both group patients. All patients were kept nil per oral for 6 hours prior to surgery time at Operation theatre. Premedication with Inj. Ondansetron 4mg IV+ Inj. Rabeprazole20 mg IV were given for all patients 1 hour prior to surgery in the pre- operative room. A nurse not clinically involved in the study followed the randomization sequence using a computer generated random number chart with a block size of four and a 1:1 allocation ratio. The same nurse prepared sequentially numbered, opaque and sealed envelopes to implement the sequence,with either Tab Ivabradine 5mg or placebo and administered it to the patient with sips of water about 1 hour before intubation, after obtaining permission from the researcher without disclosing the name of the tablet. All patients and care providers, including anesthesiologists and study personnel were blinded during group allocation. All patients had intravenous infusion of IV uid Ringer's lactate on ow prior to induction. Patient was shifted into the Operating room and connected to monitors after placing supine on the OT table.Pulse Rate (PR), Respiratory Rate (RR), Non-invasive blood pressure (NIBP), Oxygen Saturation (SpO2) and Electrocardiogram (ECG) monitoring was done using a standard calibrated monitor. The premedication, induction agent and muscle relaxant to facilitate intubation were standardized for both the groups. Baseline HR,SBP,DBP and MAP were recorded and preoxygenation done for 3 min with a facemask.The patient induced by Inj Propofol 2mg/ kg and Inj Fentanyl 1 mcg/kg. Intubation facilitated by using Inj. Vecuronium 0.1mg/kg i.v. ATTENUATION OF HEMODYNAMIC RESPONSE TO ENDOTRACHEAL INTUBATION USING ORAL IVABRADINE - A PROSPECTIVE RANDOMISED CONTROLLED DOUBLE BLIND STUDY Original Research Paper Dr.Syed Rubiya Sultana DNB Anaesthesia registrar, Dr. Jeyasekharan Hospital, Nagercoil, Tamilnadu, India-629003 Anaesthesiology BACKGROUND:Rapid and dramatic hemodynamic changes which adversely affect the patient may occur during laryngoscopy and intubation. The present study evaluates the effect of oral ivabradine on the hemodynamics during laryngoscopy and endotracheal intubation in patients undergoing surgical procedures under general anesthesia with ETT. STUDY DESIGN: A prospective, randomized, controlled, double-blind study. MATERIAL AND METHODS: 90 ASA I and II patients who underwent elective surgeries under general anaesthesia at Dr Jeyasekharan Hospital and Nursing Home, were randomly divided into two groups of 45 each. Group A received Tab Ivabradine 5 mg and group B received Tab B complex.The hemodynamic parameters namely HR,SBP,DBP and MAP were monitored prior to the study drug as baseline and at the following time intervals ;after induction, after intubation, ,after 1,3,5,8 and 10 minutes after intubation. RESULTS: HR was signicantly lower in the ivabradine group compared to control group at all time interval after study drug. SBP,DBP&MAP were signicantly lower in the Ivabradine group compared to control group after induction, after intubation, and 1,3,5,8 and 10 minutes after intubation. CONCLUSIONS: Ivabradine given before intubation prevents signicant rise in HR and SBP, DBP, MAP compared to placebo in patients during laryngoscopy and endotracheal intubation. ABSTRACT KEYWORDS : Dr.Renu Devaprasath HOD Dept. Anaesthesia, Dr. Jeyasekharan Hospital, Nagercoil, Tamilnadu, India-629003 Dr Renjith I DNB Anaesthesia registrar, Dr. Jeyasekharan Hospital, Nagercoil, Tamilnadu, India-629003 Dr. S. NishalPerumal* Anaesthesiologist,Dr. JeyasekharanHospital,Nagercoil, Tamilnadu, India- 629003 *Corresponding Author 16 X GJRA - GLOBAL JOURNAL FOR RESEARCH ANALYSIS VOLUME-9, ISSUE-3, MARCH-2020 • PRINT ISSN No. 2277 - 8160 • DOI : 10.36106/gjra The lungs ventilated with 100% oxygen for 60 seconds. Intubation done at around 60 minutes after Ivabradine pre- treatment in group-1 and 60 min after placebo in group -2 (correlating with peak action of the drug). Intubation achieved with an appropriate size oral, cuffed, portex endotracheal tube by the aid of Macintosh laryngoscope blade. HR,SBP, DBP and DBP were recorded post induction, post intubation and at predetermined intervals. Balanced anesthesia was maintained with Vecuronium bromide (0.02mg/kg) top-up doses; and intermittent positive pressure ventilation with nitrous oxide and oxygen in the ratio of 66%: 33% using circle absorber system connected to Anesthesia work station. The surgeon was requested to defer putting the incision until 1,3,5,8 and 10 minutes recordings were completed .Any post induction hypotension (MAP < 20%) was managed with uid bolus of NS 250 to 300 ml and ephedrine 6mg IV and with Inj atropine 0.6 mg if heart rate was less than 20% of baseline heart rate. Parameters recorded were heart rate, systolic BP, diastolic BP, Mean arterial pressure. Ten minutes after intubation, after taking the recordings of hemodynamic parameters, inhalational agent was introduced into the anesthetic technique. The study was discontinued once the sample size of 90 patients have been studied. The statistical analysis was done using SPSS (Statistical Package for Social Sciences) Version 2020 statistical Analysis Software. Signicance level is decided before starting study- 95% The parametric variables were collected and were analyzed by independent t- test.Statistical analysis was performed using Chi-Square for non-parametric samples. P<0.05 was considered as statistically signicant.Master chart was prepared using the available individual data from the patient proformas , following which the data was analyzed. RESULTS AND DISCUSSION Present study was undertaken to study the hemodynamic changes following intubation between patients who received oral ivabradine and those who did not. Blood pressure and heart rate response to direct laryngoscopy and endotracheal intubation was studied in both the groups. TABLE-1: HR CHANGES IN BOTH GROUPS PLACEBO(n=45) IVABRADINE(n=45) t df P VALUE Mean sd Mean sd HEART RATE - BASELINE 84.22 11.419 77.13 8.05 3.404 79.069 0.001 HR-AT INDUCTION 87.29 10.593 79.02 7.823 4.211 88 <0.001 HR-AT INTUBATION 91.36 10.671 76.71 7.765 7.444 88 <0.001 HR-1 MIN AFTER INTUBATION 89.51 10.211 74.76 7.595 7.778 88 <0.001 HR-3 MIN AFTER INTUBATION 88.24 10.107 73.42 7.359 7.953 88 <0.001 HR-5 MIN AFTER INTUBATION 86.67 9.902 71.96 7.483 7.951 88 <0.001 HR-8MIN AFTER INTUBATION 86.4 9.804 71.13 7.307 8.376 88 <0.001 HR-10 MIN AFTER INTUBATION 85.64 9.815 70.71 6.992 8.313 79.516 <0.001 TABLE-2 : SBP CHANGES IN BOTH GROUPS PLACEBO(n=45) IVABRADINE(n=45) t df P VALUE Mean sd Mean sd SBP-BASELINE 114.42 7.275 116 6.671 -1.072 88 0.287 SBP-AT INDUCTION 119.42 7.216 121.91 6.643 -1.702 88 0.092 SBP-AT INTUBATION 117.69 7.332 119.56 6.416 -1.285 88 0.202 SBP-1 MIN AFTER INTUBATION 115.56 7.573 117.04 6.684 -0.989 88 0.325 SBP -3MIN AFTER INTUBATION 113.42 7.347 114.73 6.545 -0.894 88 0.374 SBP-5 MIN AFTER INTUBATION 111.51 6.871 112.6 6.429 -0.776 88 0.44 SBP 8 MIN AFTER INTUBATION 109.84 6.829 111.18 6.114 -0.976 88 0.332 SBP-10 MIN AFTER INTUBATION 108.8 6.666 110.62 6.154 -1.347 88 0.181 TABLE-3 :DBP CHANGES IN BOTH GROUP PLACEBO(n=45) IVABRADINE(n=45) t df P VALUE Mean sd Mean sd DBP-BASELINE 68.29 7.54 69.71 5.558 -1.019 88 0.311 DBP-PRE INDUCTION 72.18 7.114 73.67 5.669 -1.098 88 0.275 DBP-AT INTUBATION 70.93 6.607 71.53 5.599 -0.465 88 0.643 DBP-1 MIN AFTER INTUBATION 69.18 6.576 69.71 5.763 -0.409 88 0.683 DBP-3 MIN AFTER INTUBATION 67.62 6.461 68.31 5.744 -0.535 88 0.594 DBP-5 MIN AFTER INTUBATION 66.33 6.36 67.04 5.657 -0.56 88 0.577 DBP- 8MIN AFTER INTUBATION 65.51 6.24 66.18 5.293 -0.547 88 0.586 DBP-10 MIN AFTER INTUBATION 64.4 6.103 65.62 5.577 -0.992 88 0.324 TABLE-4 :MAP CHANGES IN BOTH GROUPS PLACEBO(n=45) IVABRADINE(n=45) t df P VALUE Mean sd Mean sd MAP-BASELINE 83.6756 6.52569 85.07 4.65037 -1.167 88 0.246 MAP- PRE INDUCTION 88.2422 6.23183 89.9133 4.8288 -1.422 88 0.159 MAP-AT INTUBATION 86.678 6.1195 87.538 4.8065 -0.741 88 0.46 MAP-1 MIN AFTER INTUBATION 84.7467 6.04414 85.446 4.91947 -0.602 88 0.549 MAP-3 MIN AFTER INTUBATION 82.9311 5.96356 83.766 5.4364 -0.694 88 0.489 MAP-5 MIN AFTER INTUBATION 81.58 5.77351 82.3111 4.92091 -0.647 88 0.52 MAP -8 MIN AFTER INTUBATION 80.45111 5.584256 81.17756 4.654674 -0.67 88 0.504 MAP-10 MIN AFTER INTUBATION 79.5222 5.53776 80.5538 4.72255 -0.951 88 0.344 X 17GJRA - GLOBAL JOURNAL FOR RESEARCH ANALYSIS VOLUME-9, ISSUE-3, MARCH-2020 • PRINT ISSN No. 2277 - 8160 • DOI : 10.36106/gjra TABLE-5 : DISTRIBUTION OF AGE, WEIGHT, HEIGHT AND BMI There is no signicant difference in distribution of age, weight, height and BMI between two groups. FIGURE-1: SEX DISTRIBUTION IN TWO GROUPS No signicant difference in distribution of sex and ASA between two groups. FIGURE-2: ASA DISTRIBUTION IN TWO GROUPS In this study HR was signicantly lower with a p value <0.001 in the Ivabradine group compared to control group at all time interval after study drug. SBP, DBP&MAP were signicantly lower in the Ivabradine group compared to control group after induction, after intubation, and 1,3,5,8 and 10 minutes after intubation. DISCUSSION Rapid and dramatic hemodynamic changes adversely affect the patient. These changes may occur during the perioperative period. Hypertension and tachycardia have been recognized as commonly associated with intubation under light anesthesia and is most evident during laryngoscopy and intubation. The effect is usually arising within 30 seconds after endotracheal intubation and lasting less than 10 minutes thereafter. Hence controlling hemodynamic changes is an important aspect of anesthetic management to prevent complications. Various strategies have been implemented for the attenuation of hemodynamic response to laryngoscopy and intubation with tracheal spray of lignocaine, increasing the depth by inhalational agents, various drugs like Labetalol, Nitroprusside, Calcium channel blockers, etc but only few recent studies in southern part of India has been done with oral Ivabradine. CONCLUSIONS This study concluded that oral Ivabradine has better heart rate control than placebo for attenuation of hemodynamics during laryngoscopy and endotracheal intubation in ASA 1 and 2 patients without side effects. Conicting Interests Author declares no conict of interest. Funding - No funding agency Ethical approval - Obtained Informed consent- Obtained AcknowledgementsI would like to thank the patients for cooperating with us throughout the study period. I thank the department of anaesthesia for helping in conducting and publishing this study. REFERENCES 1. C. G.R. Singh D, Kabra Av. Attenuation Of Hemodynamic Response To Laryngoscopy And Endotracheal Intubation Using Intra-Oral Ivabradine: A Clinical Study. J Evol Med Dent Sci. 2014 Aug 27;3(39):9944–55 2. Prevention of Haemodynamic Changes during Laryngoscopy and Endotracheal Intubation- A Clinical Study of Oral Ivabradine Rajesh Kunwer1 , Mamta Joshi2 , Saurabh Pathak ISSN (Online): 2393-915X; (Print): 2454-7379 | ICV: 50.43 | Volume 3 | Issue 7 | July 2016 3. K.D. Tripathy M.D. Essentials of medical pharmacology 7th edition. Chapter 39;559. Chapter 29 ; page361- 366. 4. Ibrahim A, Atallah R. Ivabradine versus propranolol given orally in microlaryngoscopic surgeries in attenuating stress response: A comparative prospective double blind randomized study. Egyptian Journal of Anaesthesia. 2016;32(4):503-511. 5. A. J. Shribman, g. Smith and k. J. Achola Cardiovascular and catecholamine responses To laryngoscopy with and without Tracheal intubation A. J. Shribman, g. Smith and k. J. Achola Br. J. Anaesth. (1987), 59, 295-299. PLACEBO(n=45) IVABRADINE(n =45) t Df P VALUE Mean sd Mean Sd AGE 35.62 8.909 33.56 8.683 1.114 88 0.268 WEIGHT 61.5333 6.9922 57.67226.17956 2.776 88 0.007 HEIGHT 157.56 4.099 152.91 8.19 3.402 64.736 0.001 BMI 24.751112.552683 24.717782.5853860.062 88 0.951 18 X GJRA - GLOBAL JOURNAL FOR RESEARCH ANALYSIS VOLUME-9, ISSUE-3, MARCH-2020 • PRINT ISSN No. 2277 - 8160 • DOI : 10.36106/gjra