A RANDOMIZED CLINICAL TRIAL TO COMPARE NEBULIZED ROPIVACAINE (0.75 percent) WITH NEBULIZED DEXMEDETOMIDINE ON THE HEMODYNAMIC RESPONSE TO INTUBATION IN PATIENTS UNDERGOING GENERAL ANESTHESIA
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Archana
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- To compare and evaluate the effectiveness of nebulized Ropivacaine (0.75%) and nebulized Dexmedetomidine in attenuating the hemodynamic response during laryngoscopy and endotracheal intubation
Overview
Brief Summary
All patients included in the study will undergo General physical examination, airway assessment and systemic examination will be done and consent will be taken one day prior to the study. Standard monitoring of hemodynamic parameters (blood pressure, pulse rate, saturation, respiration rate) are done in the preoperative room. On the day of surgery patients are divided into 2 groups with 64 patients each. GROUP D received NEBULIZED DEXMEDETOMIDINE (1mcg/kg) with normal saline 5 ml and GROUP R will receive NEBULIZED ROPIVACAINE (0.75%) 5ml.Patients will receive nebulization 15mins prior to the intubation. Patients are connected to the monitors as per as American Society of Anesthesiologist classification (ASA) guidelines and baseline parameters are monitored in the operative room. Patients are induced according to institutional policy and laryngoscopy should not exceed more than 15 seconds.
The primary aim of the study is to compare the hemodynamic response with nebulized dexmedetomidine and nebulized ropivacaine and accordingly parameters are measured at various time points like - baseline before and after nebulization, before and after tracheal intubation, minutes after tracheal intubation, at the time of skin closure and immediately and 5 minutes after tracheal extubation.
The secondary aim of the study is to compare the hemodynamic parameters at extubation, and to compare the cough response to extubation
and the incidence rate of postoperative sore throat. Any adverse effects in the perioperative period will be managed as per the institutional policy.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •It includes patients with ASA grade 1 and 2 patients with Mallampati grade 1 and 2 elective surgeries with duration of less than 120 mins.
Exclusion Criteria
- •it excludes hemodynamically unstable patients patients with history of sore throat or upper respiratory tract infection patients with allergy to local anesthetics and dexmedetomidine patients with history of cardiac, liver and renal disorders patients with difficult airway where a laryngoscopy is expected to take more than 15 seconds.
Outcomes
Primary Outcomes
To compare and evaluate the effectiveness of nebulized Ropivacaine (0.75%) and nebulized Dexmedetomidine in attenuating the hemodynamic response during laryngoscopy and endotracheal intubation
Time Frame: THE HEMODYNAMIC RESPONSE MEASURED | T0- baseline before nebulization | T1- immediately after nebulization | T2- before tracheal intubation | T3- immediately after tracheal intubation | T4 - 5 minutes after tracheal intubation | T5- at the closure of the skin incision | T6- immediately after tracheal extubation | T7-5 minutes after tracheal extubation
Secondary Outcomes
- TO ASSESS(1.THE HEMODYNAMIC PARAMETERS AT EXTUBATION)
Investigators
Dr. Archana
SHRI B.M. PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER