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CTRI Number  CTRI/2024/08/072024 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 02/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of ketodex and dexmedetomidine sedation for ear surgery 
Scientific Title of Study   Comparison of ketamine-dexmedetomidine and dexmedetomidine infusion in middle ear surgeries under monitored anesthesia care. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nirali Nimeshkumar Panchal 
Designation  Professor  
Affiliation  Pramukhswami medical college 
Address  Department of anaesthesiology, Pramukhswami medical college, Karamsad, Anand

Anand
GUJARAT
388315
India 
Phone  09825031808  
Fax    
Email  dr.niralipanchal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Nirali Panchal  
Designation  Professor  
Affiliation  PRAMUKHSWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY 
Address  Department of anaesthesiology, Pramukhswami medical college, Karamsad, Anand

Anand
GUJARAT
388315
India 
Phone  09825031808  
Fax    
Email  dr.niralipanchal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Pradip Asari 
Designation  2nd year anesthesia resident  
Affiliation  Pramukhswami medical college 
Address  Department of anaesthesiology, Pramukhswami medical college, Karamsad, Anand

Anand
GUJARAT
388325
India 
Phone  917990599017  
Fax    
Email  asaripradip8524@gmail.com  
 
Source of Monetary or Material Support  
Pramukhswami medical college, Karamsad, Anand, Gujarat, India, 388325 
 
Primary Sponsor  
Name  Pramukhswamu medical college 
Address  Pramukhswami medical college, Karamsad, Anand, Gujarat, India, 388325 
Type of Sponsor  Private 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 Nirali Panchal  Pramukhswami medical college Shree Krishna hospital  Department of anaesthesiology Pramukhswami medical college Karamsad Anand
Anand
GUJARAT 
09825031808

dr.niralipanchal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee-2 Bhaikaka University karamsad Anand Gujarat  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 
Intervention  Inj. Ketamine and Inj. Dexmedetomidine  Infusion of 50 mg (1 ml) of ketamine and 50 mcg (1 ml) of dexmedetomidine will be diluted in 23ml of normal saline (NS). Patient will receive a loading dose of ketamine 0.5 mg/kg, dexmedetomidine 0.5mcg/kg over 10 min, followed by a maintenance dose of ketamine 0.3 mg/kg/h and dexmedetomidine 0.3 mcg/kg/h. 
Comparator Agent  Inj.Dexmedetomidine  Infusion of 50 mcg (1 ml) of dexmedetomidine will be diluted in 24ml of normal saline. Patient will receive a loading dose of 0.5mcg/kg, followed by a maintenance dose of 0.3 mcg/kg/hr. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  American society of Anesthesiologists (ASA) Grade 1 to 3
o Patients undergoing middle ear surgeries under MAC 
 
ExclusionCriteria 
Details  Patients undergoing middle ear surgeries under General Anaesthesia
Known allergic to study medications
Patients with renal dysfunction
Patients with heart rate below 60/min
Pregnant patient
History of taking sedative or opioid medication since last one month
Known neurological or neuromuscular disorders
Bmi equal to more than 30 kg/m2 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assess the onset time of sedation of inj. ketamine - dexmedetomidine and inj.dexmedetomidine during Monitor
Anaesthesia care for middle ear surgeries. 
baseline, every 1 minutes till ramsay sedation score is 3  
 
Secondary Outcome  
Outcome  TimePoints 
Assess the intra-operative hemodynamic (Heart rate, Mean arterial pressure)  During surgery  
Assess recovery time  After surgery  
Assess surgeon satisfaction  after surgery  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   N/A 
Date of First Enrollment (India)   15/08/2024 
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="6"
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   Pre-anaesthetic check-ups will be conducted on all the patients before the surgery. Patients will be counselled for sedation, use of local anaesthesia and the details of the operative procedure. Patients will be kept nil by mouth 8 hours for solid and 2 hours for clear liquid. On the day of surgery non-invasive blood pressure, pulse oximetry, electrocardiogram will be attached and baseline parameters will be recorded. Oxygen supplementation will be given using a face mask. Inj. Glycopyrolate 0.2mg and inj. Midazolam 0.02 mg/kg will be given. Group allocation will be done using opaque envelope method. Sedation will be started according to group allocation.
Group KD: Infusion of 50 mg (1 ml) of ketamine and 50 mcg (0.5 ml) of dexmedetomidine will be diluted in 23ml of normal saline (NS). Patient will receive a loading dose of ketamine 0.5 mg/kg, dexmedetomidine 0.5mcg/kg over 10 min, followed by a maintenance dose of ketamine 0.3 mg/kg/h and dexmedetomidine 0.3 mcg/kg/h.
Group D: Infusion of 50 mcg (1 ml) of dexmedetomidine will be diluted in 24ml of normal saline. Patient will receive a loading dose of 0.5mcg/kg, followed by a maintenance dose of 0.3 mcg/kg/hr. After starting sedation, when Modified Ramsay Sedation- 3 (no spontaneous eye opening, response to vocal stimulus) achieved this time will be noted as onset time of sedation (primary objective of the study) surgeon will be allowed to give local anaesthesia infiltration. The heart rate, mean arterial blood pressure, sedation score will be monitored every 10 minutes. Heart rate less than 60/min will be considered as bradycardia and will be treated with inj. Glycopyrrolate. Systolic blood pressure less than 20% of base line will be consider as hypotension and will be treated with fluid challenge and inj. Mephentermine 6mg.
Infusion will be increased for fall in Modified Ramsay Sedation score less than 3 and vice versa. Nausea- vomiting will be treated with inj. Ondansetron 8mg. Desaturation(SpO2 < 94%) will be manage with increasing oxygen supplement, nasopharyngeal airway, bag and mask ventilation. If desaturation persist patient will be intubated. And such patients will be excluded from the study.
Once the surgery will complete the surgery, patient will be shifted to post anaesthesia care unit (PACU) and postoperative recovery and PACU discharge readiness will be assess using modified Aldrete score and time will be noted.
Postoperative analgesia will be assessed by VAS score before shifting patient to PACU and if score more than 4. inj. Paracetamol 1gm will be given. Surgeon satisfaction according to likert scale (poor, good, excellent) will be recorded.
 
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