A Phase 4 interventional study of lignocaine+bicarbonate and lignocaine+dexamethasone in Anesthesia, Anesthesia; Adverse Effect and Anesthesia Intubation Complication, sponsored by Aligarh Muslim University. Completed at 1 site in India. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-03.
Sponsored by Aligarh Muslim University · Phase 4, Interventional, and Supportive care
This study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.
Objective Recently multiple studies have shown better outcomes with usage of dexamethasone or alkalinized lignocaine instead of air for filling endotracheal tube (ETT) cuff. So this study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.
Design and setting:
This is a prospective single blind, randomized controlled study at the department of anesthesiology, JNMCH, AMU, Aligarh.
Materials and methods:
Investigators plan to include 100 patients of age group within 18-60 years with American Society of Anesthesiologists (ASA) class I \& II, posted for elective surgery of duration >120 minutes, performed under general anesthesia; administered as per institutional protocols. Patients with ASA III \& IV, cardiovascular morbidities, known drug allergy, pregnancy will be excluded from the study. Patients will be divided into two groups randomly according to chit-in-box method, viz Group A \& Group D with fifty patients in each group. Patient group allocation, preparation of drug mixture for endotracheal cuff filling as per group assigned and analysis of observed data will be done by a separate anesthetist not involved in the perioperative management of the patient. In patients belonging to Group (A), ETT cuff will be filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in the proportions of 0.5: 9.5 ml while in Group D the ETT cuff will be filled with mixture of dexamethasone with 2% lignocaine in the proportions of 0.5: 9.5 ml . The cuff of the ETT will be slowly inflated until no leak is heard at all during the peak airway pressure of the ventilator cycle while auscultating the trachea . Volume of drug mixture in the cuff will be noted at start and end of surgery. Total duration of anesthesia will be noted.
Hemodynamic stability at the time of extubation will be meausred in terms of changes in rate pressure product (RPP) which will denote the product of heart rate and systolic blood pressure. RPP values recorded immediately after stoppage of the anesthetic agents at the end of surgery will be compared to the values measured just after the extubation of trachea. Patient's satisfaction from anesthesia given will be recorded, based on VAS. The presence of coughing and bucking will also be noted. Incidence of postoperative sore throat and cough will be recorded at 1 hour and 24 hours post extubation.
The results will be presented in number, percentage, mean, and standard deviation as appropriate. Appropriate statistical tests will be applied and P value less than 0.05 will be considered as statistically significant.
Aligarh Muslim University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endotracheal tube cuff was filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in a ratio of 0.5:9.5 ml
Drug: lignocaine+bicarbonate
Endotracheal tube cuff was filled with mixture of dexamethasone with 2% lignocaine in a ratio of 0.5:9.5 ml
Drug: lignocaine+dexamethasone
Drug pages: Lidocaine · Bicarbonates
ETT cuff was filled with mixture of 2% lignocaine with bicarbonate
Drug pages: Lidocaine · Dexamethasone
ETT cuff was filled with mixture of 2% lignocaine with dexamethasone
smoothness of extubation
Grade 1= coughing, bucking, tube biting, agitatation present. Grade 2= mild bucking/coughing. Grade 3= completely comfortable, tolerating tube in situ, no coughing/bucking/agitation.
Time frame: time from adequate reversal of anaesthesia & muscle paralysis (head holding >5sec, eye opening on command, train of four ratio >0.9) till removal of endotracheal tube.
patient satisfaction score
rated on visual analog scale varying 0 to 10; where 0 is worst experience and 10 is best. completely
Time frame: post operative 1 hour
Haemodynamic stability at the time of extubation.
Rate pressure product (RPP); \[RPP=Product of systolic blood pressure(mmHg) and heart rate (beats per min)\] measured after stopping the anaesthetic agents at the end of surgery will be taken as baseline and then compared to values measured immediately after the removal of endotracheal tube.
Time frame: values of product of systolic blood pressure and heart rate will be compared after stopping the anesthetic agents and immediately after the extubation
amount of drug diffused through endotracheal tube cuff
Volume of drug mixture in the cuff was noted at start and end of surgery.
Time frame: from start till end of surgery.
incidence of post operative cough and sore throat
incidence of post operative cough and sore throat
Time frame: after 1 and 24 hour post extubation
duration of surgery
duration of surgery
Time frame: duration of surgery
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Studies of the drugs tested here: Lidocaine · Bicarbonates
Aligarh Muslim University