Intranasal dexmedetomidine to the effects of blood pressure and heart rate to intubation
- Conditions
- Essential (primary) hypertension, (2) ICD-10 Condition: E039||Hypothyroidism, unspecified, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2021/05/033305
- Lead Sponsor
- SUJATHA
- Brief Summary
Institutional ethical committee approval will be obtained.
Patients will be enrolled in the study after obtaining informed consent.
Randomization is done by computer generated random number table to either undergo 0.7 mcg/kg intranasal dexmedetomidine or 1 mcg/kg intranasal dexmedetomidine or intravenous lignocaine 1.5 mg /kg.
The patient and the person administering the drug, performing laryngoscopy and monitoring the vital parameters will be blinded to the group assignment. Blinding is ensured by asking a person who is not involved in the study to load the drug as per the allocated groups.
Preoperatively Nil per oral orders will be followed as per guidelines.
On the day of surgery, the patient will be shifted to perioperative area 1 hour before the surgery. The standard monitors will be attached and baseline parameters will be recorded using pulse oximetry, non invasive blood pressure. IV Ringer lactate solution will be administered as maintenance fluid ( 80 ml /hr ) through the 18 G peripheral venous cannula.
Group A will be receiving intranasal dexmedetomidine 0.7mcg/kg, administered by an atomiser 30 min before induction. 10 ml of Normal saline will be administered intravenously to group A patients 90 seconds before intubation.
Group B patients will be receiving intranasal dexmedetomidine 1mcg/kg , administered by an atomiser 30 min before induction .10 ml of Normal saline will be administered intravenously to group B patients 90 seconds before intubation.
Group C patients will be receiving intravenous lignocaine 1.5 mg/kg, administered 90 sec before intubation .1 ml of normal saline will be administered intranasally 30 min before induction.
The delivery of dexmedetomidine is done with an atomiser. An equal volume of drug will be given via 2 nostrils. Atomisation will be performed with the participant sitting up with slight backward head tilt as this allows optimal spread and absorption of atomised solutions.
In the preoperative holding area , the vital parameters like HR, SBP, DBP, MAP, Ramsay sedation score will be noted .
After shifting the patient to the operative room, the general anesthesia techniques will be standardised to three groups. After preoxygenation with 100%oxygen for 3 minutes, the patient will be induced with Iv fentanyl 2 mcg/kg ,Iv propofol 2 mg/kg and Iv cisatracurium 0.2 mg/kg. Intubation will be done by DL scopy after 90 seconds of cis atracurium administration. Duration of laryngoscopy – time of insertion of laryngoscope till the appearance of ETCO2 trace will be noted. Patients will be excluded if there is more than two attempts of laryngoscopy. Hemodynamic parameters will be measured at preinduction, preintubation ,postintubation every 3 min for over 10 mins .Anesthesia will be maintained with 50%oxygen-air mixture and cisatracurium will be repeated as and when necessary. The hemodynamic parameters will be monitored throughout the operative period. Episodes of hypotension (decrease in MAP of 20% from baseline) , bradycardia (HR < 50 bpm ) and hypoxia (spo2 < 90% ) within the study period will be noted and treated accordingly . After completion of surgery ,the patients will be reversed with IV neostigmine 0.05 mg/kg and IV glycopyrolate 0.01mg /kg
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 102
18 to 60 yrs elective surgery under general anesthesia.
1.patient refusal 2.allergy to dexmedetomidine 3.significant respiratory and cardiac disease 4.predicted difficult airway patient with nasal polyps,ulcers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TO COMPARE THE SYSTOLIC BLOOD PRESSURE, DIASTOLIC BLOOD PRESSURE ,MEAN ARTERIAL PRESSURE 0 min,30 min,preinduction,preintubation,postinduction for over 10 min
- Secondary Outcome Measures
Name Time Method TO COMPARE THE SEDATION SCORE AND OTHER ADVERSE EVENTS 3 HRS
Trial Locations
- Locations (1)
SRI RAMACHANDRA INSTITUTE OF MEDICAL SCIENCE AND RESEARCH INSTITUTE
🇮🇳Chennai, TAMIL NADU, India
SRI RAMACHANDRA INSTITUTE OF MEDICAL SCIENCE AND RESEARCH INSTITUTE🇮🇳Chennai, TAMIL NADU, IndiaSUJATHAPrincipal investigator09487704101sujathasrinivasan4343@gmail.com