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CTRI Number  CTRI/2021/05/033305 [Registered on: 03/05/2021] Trial Registered Prospectively
Last Modified On: 04/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Intranasal dexmedetomidine to the effects of blood pressure and heart rate to intubation 
Scientific Title of Study   EFFICACY OF DIFFERENT DOSES OF INTRANASAL DEXMEDETOMIDINE ON HEMODYNAMIC RESPONSE TO INTUBATION - A PROSPECTIVE DOUBLE BLINDED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sujatha 
Designation  postgraduate 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  Department of Anesthesiology and pain medicine, Sri Ramachandra institute of higher education and research ,Porur , Chennai , Tamilnadu - 600116 , India

Chennai
TAMIL NADU
600116
India 
Phone  09487704101  
Fax    
Email  sujathasrinivasan4343@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DRMAHESH VAKAMUDI 
Designation  Professor of department of Anesthesiology 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  Department of Anesthesiology and pain medicine, Sri Ramachandra institute of higher education and research ,chennai , tamilnadu - 600116 , India

Chennai
TAMIL NADU
603001
India 
Phone  9840022626  
Fax    
Email  vakamudi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sujatha 
Designation  postgraduate 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH 
Address  Department of Anesthesiology and pain medicine, Sri Ramachandra institute of higher education and research , Porur , Chennai , Tamilnadu - 600116

Chennai
TAMIL NADU
600116
India 
Phone  09487704101  
Fax    
Email  sujathasrinivasan4343@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra institute of higher education and research institute ,porur ,chennai 
 
Primary Sponsor  
Name  SUJATHA 
Address  NO.82,PILLAIYAR KOVIL STREET,CHENGALPATTU 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SUJATHA  SRI RAMACHANDRA INSTITUTE OF MEDICAL SCIENCE AND RESEARCH INSTITUTE  Department of Anaesthesiology and Pain Medicine, Sri Ramachandra Institute of Higher education and research , Porur , Chennai , Tamilnadu - 600116
Chennai
TAMIL NADU 
09487704101

sujathasrinivasan4343@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH INSTITUTE,PORUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INTRANASAL DEXMEDETOMIDINE  INTRANASAL DEXMEDETOMIDINE 0.75mcg/kg , 40 min before intubation 
Intervention  INTRANASAL DEXMEDETOMIDINE  INTRANASAL DEXMEDETOMIDINE 1 mcg/kg ,40 min before intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  age - 18 to 60 yrs
elective surgery under general anesthesia 
 
ExclusionCriteria 
Details  1.patient refusal
2.allergy to dexmedetomidine
3.significant respiratory and cardiac disease
4.predicted difficult airway
patient with nasal polyps,ulcers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
TO COMPARE THE SEDATION SCORE AND OTHER ADVERSE EVENTS  3 HRS 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/05/2021 
Date of Study Completion (India) 30/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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

 
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