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
|
|
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
|
|
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 |