Anesthesia Clinical Trial
Official title:
Comparision of Addition of Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in Terms of Extubation Characteristics and Patient Satisfaction Undergoing General Anaesthesia
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.
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