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CTRI Number  CTRI/2024/08/072317 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 10/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of oral clonidine with oral midazolam as pre-medication in paediatric patients in Sawangi, Maharashtra 
Scientific Title of Study   Comparison Of clonidine with midazolam as pre anaesthetic oral medication in paediatric patients in Sawangi, Maharashtra 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shyamolima Bhuyan 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9359008510  
Fax    
Email  shybhuyan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shyamolima Bhuyan 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9359008510  
Fax    
Email  shybhuyan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shyamolima Bhuyan 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9359008510  
Fax    
Email  shybhuyan@gmail.com  
 
Source of Monetary or Material Support  
Acharya Vinobha Bhave Rural Hospital, Sarwangi, Maharashtra 442001, India. 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College 
Address  Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra- 442001, India 
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 Shyamolima Bhuyan  Acharya Vinobha Medical College  Department of Anaesthesia, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra
Wardha
MAHARASHTRA 
9359008510

shybhuyan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research  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  Clonidine  Clonidine will be administered as preanaesthetic medication at a dose of 4 mcg/kg per orally for 120 minutes 
Intervention  Midazolam  Midazolam will be administered as preanaesthetic medication at a dose 0.5 mg/kg per orally for 120 minutes 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Patients aged 2-12 years
2. Patients posted for surgery under general anaesthesia
3. Patients whose parents/ guardians provide consent. 
 
ExclusionCriteria 
Details  1.Patients less than 2 year of age
2.Patients more than 12 years of age
3. Weight of more than 95th percentile for age
4. Patients with a difficult airway
5. Patients with mental retardation
6. Patients with central nervous system disorders
7. Patients on anticonvulsants or sedative medications
8. Patients who will require additional sedation. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare oral clonidine with oral midazolam as preanaesthetic medication  1. at separation
2. at venepuncture
3. at mask application 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of haemodynamic status of patients recieving oral clonidine & oral midazolam  1. at separation
2. at venepuncture
3. at mask application 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   31/08/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The preoperative period is a stressful period and a major source of anxiety for all patients especially in the paediatric population. Preoperative anxiety in children is a natural response that that produces a negative experience for both patient and parent and thus warrants attention. An ideal pre anaesthetic medication should reduce separation anxiety from the parent, allow for easy and smooth induction of anaesthesia without causing prolongation of emergence or increasing post operative nausea, vomiting and delirium. Oral premedication is commonly used in paediatric population prior to surgery. The ideal pre anaesthetic agent ought to have a fast and dependable onset, negligible results, quick recuperation and ought to work with smooth acceptance of sedation

Midazolam is a water-soluble benzodiazepine. It used as a preanaesthetic medication by several routes including oral, intravenous, intranasal and intramuscular. It has sedative and amnestic effects. Midazolam is the most commonly used oral premedication used in children. Oral midazolam syrup (2 mg/ml) is effective for producing sedation and anxiolysis at a dose of 0.25 mg/kg with minimal effects on ventilation and oxygen saturation even when administered at doses as large

As 1 mg/kg (maximum, 20 mg). Midazolam, 0.5 mg/kg administered orally 30 minutes before induction of anesthesia, provides reliable sedation and anxiolysis in children without producing delayed awakening. Although it is recommended that oral midazolam be administered at least 20 minutes before surgery, there is evidence that significant anterograde amnesia is present when 0.5 mg/kg orally is administered 10 minutes before surgery.

Clonidine is partial α2 receptor agonist. Premedication with clonidine produces preoperative sedation and anxiolysis in children. It also has analgesic properties, decreases volatile anesthetic requirements and improves perioperative hemodynamic stability. Although clonidine is not as common as midazolam as a premedication, it is slowly gaining popularity. It also reduces the requirements for both inhaled anesthetics during surgery as well as opioids in the postoperative period.

 Major postoperative issues include pain, emergence delirium, airway obstruction, and hypoventilation. Opioids for pain management can exacerbate airway obstruction and hypoventilation and increase postoperative emesis. Nonsteroidal anti-inflammatory Drugs such as ketorolac are not associated with the respiratory depressant and emetic side effects of opioid administration, but are associated with increased bleeding.Aim

This study aims to Compare the efficacy of oral midazolam as a pre anaesthetic medication to oral clonidine in paediatric patients undergoing tonsillectomy.

 
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