Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in General Anaesthesia
Condition: Anesthesia; Anesthesia; Adverse Effect; Anesthesia Intubation Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): lignocaine+bicarbonate; lignocaine+dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): ETT cuff was filled with mixture of 2% lignocaine with bicarbonate; ETT cuff was filled with mixture of 2% lignocaine with dexamethasone
Intervention MeSH terms: Dexamethasone; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Intracuff Dexamethasone; Intracuff Alkalinized lignocaine; General anesthesia