Comparison of three different doses of a drug, dexmedetomidine for prevention of an increase in heart rate and blood pressure as a response to laryngoscopy and intubation by assessment of haemodynamic parameters and plasma catecholamine levels by maintaining adequate depth of anesthesia
- Conditions
- Health Condition 1: K802- Calculus of gallbladder without cholecystitisHealth Condition 2: O- Medical and Surgical
- Registration Number
- CTRI/2023/12/060514
- Lead Sponsor
- Medical Research Unit of University College of Medical Sciences as an intramural grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
All ASA I and II patients, aged 18-60 years, scheduled for elective surgery under general anesthesia.
In the preoperative area, an 18 G intravenous cannula will be inserted and venous blood sample for plasma adrenaline and nor-adrenaline will be drawn for the first time. Subsequently, a ringer lactate drip at the rate of 8-10ml/kg per hour for all the study patients will be ensured.
On shifting the patient to the OR, all standard monitors including non invasive blood pressure (NIBP), oxygen saturation probe, electrocardiogram and BIS electrodes on the forehead will be applied. The baseline parameters [Ta] including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), oxygen saturation (SPo2), BIS and MOAS will be recorded.
Subsequently infusion of the study drug, which will be prepared by an independent observer who will not be involved in the study will be initiated and continued as an infusion over 10 minutes. During infusion of study drug if the oxygen saturation drops below 95%, then oxygen will be supplemented by a simple face mask at the rate of 5-6 litres/minute.
On completion of the study drug, all the parameters [Tb] will be recorded again and noted in the record sheet. Anaesthesia will be induced with Inj Propofol 2mg/kg and Inj Fentanly 2ug/kg. After, the loss of response to verbal commands (end point of induction), all the study parameters will be recorded [Tc] and BIS will be maintained between 40-60 with help of titration of propofol and inhalational agent sevoflurane. The total dose of propofol required for induction shall be noted in all the study groups.
After checking the adequacy of mask ventilation, Inj Vecuronium bromide 0.1 mg/kg I/V will be administered and at the end of 3 minutes, just before performing laryngoscopy, all parameters [Td] will be noted. A senior anesthesiologist will perform the laryngoscopy and intubation with an appropriate size endotracheal tube (ETT). The study parameters will be recorded at 1 minute [Te], 2 minutes [Tf], 3 minutes [Tg], 5 minutes [Th] and 7 minutes [Ti] after intubation in all three study groups. Anaesthesia will be maintained with oxygen: nitrous oxide in 50:50 % combination at flow of 2 litres per minute with sevoflurane and BIS will kept at all time intervals between 40-60. At time Tg, the venous blood sample for plasma adrenaline and nor-adrenaline will also be drawn for a second time. After the last recording of the study parameters, ie Ti the study will be complete.
Patients with a history of pulmonary disease like COPD, asthma, pregnancy, morbid obesity, diabetes mellitus (HbA1c > 6.5%), uncontrolled hypertension, impaired kidney or liver function, progressive neurological disease and bleeding diathesis, anticipated difficult airway, time taken for laryngoscopy and intubation exceeding more than 15 seconds, more than one attempt made for laryngoscopy and endotracheal intubation will be excluded from this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To study and compare the change in heart rate and systolic blood pressure (SBP) after administration of dexmedetomidine in all the three groups at different time intervals, maintaining BIS values between 40-60.Timepoint: 1.To study and compare the change in heart rate and systolic blood pressure (SBP) after administration of dexmedetomidine in all the three groups at different time intervals, that is baseline, after completion of study drug, after induction, just before laryngoscopy, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation and 7 minutes after intubation, maintaining BIS values between 40-60.
- Secondary Outcome Measures
Name Time Method 1.To study and compare the change in plasma adrenaline and nor-adrenaline levels following administration of three different doses of dexmedetomidine prior to laryngoscopy and intubation <br/ ><br>2.To determine the change in the Modified Observer’s Assessment of Alertness/Sedation (MOAS) Scale recorded at baseline (before) the administration of dexmedetomidine and after its completion (10 minutes) in all the three study groups. <br/ ><br>3.To determine the incidence of perioperative complications including hypotension ( >20% fall in blood pressure from baseline) and bradycardia (heart rate <60 beats/minute) or desaturation (oxygen saturation <95%) in any of the study groups at different time intervals. <br/ ><br>4.To determine the total requirement for propofol dose for anaesthesia induction in the three study groups, maintaining BIS values between 40-60. <br/ ><br>Timepoint: baeline and 3 minutes after intubation