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CTRI Number  CTRI/2023/09/057760 [Registered on: 18/09/2023] Trial Registered Prospectively
Last Modified On: 16/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The study the effect of intranasal and intravenous dexmeditomidine 
Scientific Title of Study   Comparative study of intranasal and intravenous dexmeditomidine for attenuation of haemodynamic responses to laryngoscopy and endotracheal intubation in adult surgical patients under general anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Himanshu Gautam 
Designation  PG Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 
Address  Room no-05, Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029

South West
DELHI
110029
India 
Phone  9717312007  
Fax    
Email  HIMANSHUGAUTAM9441@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Rajpal Singh 
Designation  Professor and Consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 
Address  Room no-05, Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029

South West
DELHI
110029
India 
Phone  9811858311  
Fax    
Email  doctorrajpal04@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Rajpal Singh 
Designation  Professor and Consultant  
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 
Address  Room no-05, Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029

South West
DELHI
110078
India 
Phone  9717312007  
Fax    
Email  himanshugautam9441@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College New Delhi 
Address  Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029 
Type of Sponsor  Government medical college 
 
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 
Dr Himanshu Gautam  Vardhman Mahavir Medical College and Safdarjung Hospital  Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar East, New Delhi-110029
South West
DELHI 
9717312007

himanshugautam9441@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intranasal 0.9% normal saline  Administration of intranasal 0.9% normal saline drops for attenuation of haemodynamic responces to laryngoscopy and endotracheal intubation in adult surgical patients under general anaestheia and record MAP, SBP, DBP, HR, & SPO2 at 40 and 2 mins before and 2,5,7 9 mins after intubation. 
Intervention  Intranasal dexmeditomidine  Administration of intranasal dexmeditomidine for attenuation of haemodynamic responces to laryngoscopy and endotracheal intubation in adult surgical patients under general anaestheia and record MAP, SBP, DBP, HR, & SPO2 at 40 and 2 mins before and 2,5,7 9 mins after intubation. 
Comparator Agent  Intravenous 0.9% normal saline  Administration of 0.9% normal saline for attenuation of haemodynamic responces to laryngoscopy and endotracheal intubation in adult surgical patients under general anaestheia and record MAP, SBP, DBP, HR, & SPO2 at 40 and 2 mins before and 2,5,7 9 mins after intubation. 
Intervention  Intravenous Dexmeditomidine   Administration of intravenous dexmeditomidine for attenuation of haemodynamic responces to laryngoscopy and endotracheal intubation in adult surgical patients under general anaestheia and record MAP, SBP, DBP, HR, & SPO2 at 40 and 2 mins before and 2,5,7 9 mins after intubation. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Adult patients belonging to ASA grade I &II
2.Scheduled for elecytive surgery under general anaestheia. 
 
ExclusionCriteria 
Details  1. Uncooperating, non consenting patients.
2. Known allery or hypersenstivity to dexmeditomidine.
3. Pregnant, lactating mothers, Cardiac or respratory disease, uncontrolled hypertension, diabetes mellitus type II, neurological or psychiatric disease, or any intranasal pathology{like nasal ulcers, polyps, nasaal septal deviation}.  
 
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 
Mean arterial pressure{MAP}  40 minutes before induction, 2 min before induction, 2,5,7,9 min after induction. 
 
Secondary Outcome  
Outcome  TimePoints 
Systolic blood pressure{SBP}, diastolic blood pressure{DBP} & heart rate.  40 minutes before induction, 2 min before induction, 2,5,7,9 min after induction. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   25/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   METHODOLOGY
All patients satisfying inclusion criteria will undergo detailed preanaesthetic evaluation. After explaining the nature of the study, an informed consent will be obtained from all patients willing to participate in the study, followed by a complete physical examination. 
100 adults, will be included in this study. All patients will be randomly allocated to one of study groups using computer generated randomization. The patients will be then divided into two groups Group -A(Intravenous dexmeditoidine) and Group B(Intranasal dexmeditomidine). All patients of both groups will be advised for fasting of 6 hours and premedication of tablet ranitidine (150 mg) and alprazolam (0.5 mg) on the night before surgery.

On the day of operation, all patients will be shifted to preoperative room 2 h before the operation time. Monitoring like electrocardiography (ECG), plethysmography (SPO2), non- invasive blood pressure (NIB) monitoring will be attached and baseline readings will be obtained. Intravenous access(18G) will be secured and IV Ringer’s lactate solution will be administered as maintenance fluid. The study drug will be prepared and given by some senior anaesthesiologist and monitoring of parameters will be done by different anaesthesiologist.
Group A(Dexmeditomidine intravenous) will be given IV DEXMEDITOMIDINE (0.50 ug/kg) diluted in 40 ml of normal saline (NS) through an infusion pump over 40 min and I ml of NS intranasal will be instilled in equal volume in both nostrils before induction at the same time.
Group B(Dexmeditomidine intranasal) will be instilled Im| DEXMEDITOMIDINE in both nostrils in equal volume and 40ml of normal saline (NS) intravenously through an infusion pump over 40 min before induction. All the patients of both groups will be advised not to sneeze or suck after intranasal drug administration.

Then after completion of study drug administration, patient will be shifted in the operation room, standardised monitoring like electrocardiography (ECG), plethysmography (SP02). noninvasive blood pressure (NIBP), End tidal carbondioxide (EtCO2) monitoring will be connected and before induction readings will be noted.

All patients will be pre- oxygenated with 100% oxygen for 3 minutes. Fentanyl citrate 2 meg/kg, and titrated dose of Propofol 1-2 mg/kg will be given over 45second till the loss of consciousness . After ensuring check ventilation , vecuronium bromide 0.1 mg/kg body weight will be administered intravenously. Patient will be ventilated with mixture of oxygen + NO(50:50) and Isoflurane (MAC- 1) for 4 min and then endotracheal intubation with appropriate cuffed endotracheal tube will be performed. After confirming for bilateral equal airentry, the endo-tracheal tube will be fixed and normocapnic ventilation will be started with monitoring of ECG, HR, NIBP/IBP, EtCO2 and SpOz Readings at 2,5,7and 9 minutes after intubation will be noted Maintenance of anaesthesia will be continued with 02 + NO(40:60) and Isoflurane (MAC-1) All haemodynamic parameters will be monitored continuously and any adverse events like bradycardia, tachycardia, hypertension, hypotension or arrhythmia will be recorded and appropriate management will be done. Additional doses of neuromuscular blockade i.e. inj. vecuronium bromide 0.025mg/kg as and when required and analgesic inj. fentanyl 1meg/kg one and hourly would be given according to duration of surgery. Inj Ondansetron 4mg intravenous will be given 30 min before end of surgery.
After completion of surgery, neuromuscular block will be reversed by appropriate dose of IV neostigmine (0.05 mg/kg) and glycopyrolate (0.01 mg/kg). 

After adequate muscle power recovery patient will be extubated and will be shifted to the recovery room after stabilization Patents vitals will be monitored there for 2 h and when Modified Alderate score ›9, the patient will be shifted to ward.
 
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