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CTRI Number  CTRI/2024/03/064243 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 11/03/2024
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 two medicines for prevention of confusion state in children while coming out from anaesthesia in lower abdominal surgeries using a specific anaesthetic agent 
Scientific Title of Study   Prevention of Emergence Delirium-A Randomised Controlled Study Comparing Intravenous Dexmedetomidine and Magnesium Sulphate In Children Undergoing Infra Umbilical Surgeries Under Sevoflurane Anaesthesia 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AKHIL REJI MEKKDEN 
Designation  POST GRADUATE RESIDENT 
Affiliation  ST JOHNS NATIONAL ACADEMY OF HEALTH SCIENCES 
Address  MEKKATTU HOUSE ERATTUPETTA PO ERATTUPETTA 686121 KOTTAYAM KERALA

Kottayam
KERALA
686121
India 
Phone  8921779561  
Fax    
Email  akhil.reji.mekkaden@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DEEPA BASKARAN 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ST JOHNS NATIONAL ACADEMY OF HEALTH SCIENCES  
Address  DEPARTMENT OF ANAESTHESIOLOGY, ST JOHNS MEDICAL COLLEGE HOSPITAL BENGALURU

Bangalore
KARNATAKA
560034
India 
Phone  9731245827  
Fax    
Email  anesdeepa@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR DEEPA BASKARAN 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ST JOHNS NATIONAL ACADEMY OF HEALTH SCIENCES  
Address  DEPARTMENT OF ANAESTHESIOLOGY, ST JOHNS MEDICAL COLLEGE HOSPITAL BENGALURU

Bangalore
KARNATAKA
560034
India 
Phone  9731245827  
Fax    
Email  anesdeepa@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIA 
 
Primary Sponsor  
Name  AKHIL REJI MEKKDEN 
Address  ST JOHNS NATIONAL ACADEMY OF HEALTH SCIENCES BANGALORE 560034 
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 
AKHIL REJI MEKKDEN  ST JOHNS MEDICAL COLLEGE HOSPITAL  DEPT OF ANAESTHESIA, 2ND FLOOR, ST JOHNS MEDICAL COLLEGE, SARJAPUR, KORAMANGALA, BENGALURU 560034
Bangalore
KARNATAKA 		 8921779561

akhil.reji.mekkaden@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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  DEXMEDETOMIDINE   Children in Group D will be administered a loading dose of 0.5mcg/kg of Dexmedetomidine over 10 minutes followed by an infusion of 0.2mcg/kg/hour 
Intervention  INTRAVENOUS ADMINISTRATION  INTRAVENOUS ADMINISTRATION 10 MINUTES AFTER INDUCTION FOLLOWED BY INFUSION 
Comparator Agent  MAGNESIUM SULPHATE  Children in Group M will receive 30mg/kg of Magnesium sulphate over 10 minutes followed by an infusion of 10mg/kg infusion. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  ALL CHILDREAN BETWEEN THE AGE OF 2-8 YEARS BELONGING TO ASA PHYSICAL STATUS 1,2 UNDERGOING INFRA UMBILICAL PROCEDURES UNDER GENERAL ANAESTHESIA ARE INCLUDED IN THE STUDY AFTER OBTAINING WRITTEN INFORMED PARENTAL CONSENT 
 
ExclusionCriteria 
Details  a)PARENTAL REFUSAL TO PARTICIPATE.
b)PAEDIATRIC PATIENT WITH PSYCHOLOGICAL OR BEHAVIORAL DISORDER.
c)PAEDIATRIC PATIENTS WITH CARDIOVASCULAR ,RENAL OR HEPATIC DISEASES.
d)CHILDREN WITH NEUROMUSCULAR DISEASES AND NEUROLOGICAL DISEASES. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Prevention of Emergence Delirium-A Randomised Controlled Study Comparing Intravenous Dexmedetomidine and Magnesium Sulphate In Children Undergoing Infra Umbilical Surgeries Under Sevoflurane Anaesthesia  From end of surgery to 45mins after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic stability between both groups.  from start of anaesthetic procedure to end of surgery 
to compare the effect of dexmedetomidine and magnesium sulphate on the time of recovery  from start of anaesthetic procedures to 45mins after the procedure. 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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 1 
Date of First Enrollment (India)   20/05/2024 
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="2"
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  

BACKGROUND

Emergence delirium remains an unresolved complication of general anaesthesia in paediatric patients. Prevention of emergence delirium allows smooth recovery ,less patient and parental anxiety and prevents any major psychological impact on a long run. A large number of pharmacological and non pharmological methods have been researched over years but no single day on technique has been effective.

Dexmedetomidine, an α2  agonist has been found to be useful  in prevention of emergence delirium. The drug has sedative ,analgesic properties that helps to prevent emergence delirium. It has also found to have residual sedative effect and prolongs recovery from anaesthesia. One of the drugs that has been studied in recent years is magnesium sulphate. It has been found to have neuroprotective ,anti-inflammatory and membrane stability, analgesic property. This drug has been studied for preventing emergence delirium in adults and the results have been inconsistent .Very few studies have studied the effect of magnesium sulphate in children.

  PURPOSE:

To prevent emergence delirium in paediatric patients undergoing infra umbilical surgeries under sevoflurane anesthesia.

 To compare the effect of intraoperative intravenous  dexmedetomidine and         magnesium sulphate infusion in the prevention of emergence delirium in children undergoing    infraumbilical surgeries under sevoflurane anaesthesia.

To compare the effect of the dexmedetomidine and magnesium sulphate on the time of recovery.

To compare the hemodynamic stability among the two groups

We intend to study if magnesium sulphate is as effective as dexmedetomidine in prevention of emergence delirium in paediatric patients ,so that it can be used as an alternate to dexmedetomidine due to its very good recovery profile and lack of prolonged sedative effect.


Inclusion criteria:

All children between the age of 2-8 years belonging to ASA physical status I,II undergoing infra umbilical procedures under general anaesthesia are included in the study after obtaining written informed parental consent


METHODOLOGY

·       All children were kept fasting for 6 hours for solids and 2 hours for clear liquids.

·       In the preoperative holding area, all children will be subjected to a pre anaesthetic anxiety checkup using modified YALE preoperative anxiety scale.

·       The children are randomly allocated to two groups-  Group D and Group M according to computer generated numbering system.

·       In the operating room after connecting pulse oximeter ,electrocardiogram, patients are induced with 8% sevoflurane and a mixture of 50:50 Nitrous oxide and oxygen. Once adequate plane is reached an intravenous cannula is secured.

·       Patients with an intravenous cannula in place,  are induced with 1.5-2mg/kg body weight of propofol .

·       Patient also received 10mcg/kg glycopyrrolate,0.15mg/kg of ondansetron,1.5mcg/kg of fentanyl. Intubation with appropriate sized endotracheal tube will be facilitated with 0.5mg/kg of atracurium.

·       End tidal carbon dioxide and neuromuscular monitoring is done intraoperatively

·       All children will receive 0.75ml/kg of 0.25%bupivacaine in the caudal epidural space for analgesia.

·       Children in Group D will be administered a loading dose of 0.5mcg/kg of Dexmedetomidine over 10 minutes followed by an infusion of 0.2mcg/kg/hour

·       Children in Group M will receive 30mg/kg of Magnesium sulphate over 10 minutes followed by an infusion of 10mg/kg infusion.

·       Intraoperative Heart rate,Non invasive BP,SPO2 will be monitored every 5 minutes through out the surgery and anaesthesia is maintained with 0.8-1 end tidal sevoflurane and intermittent boluses of atracurium.

·       The surgical incision is made only after the completion of loading doses.

·       If there is a 20%increase in the heart rate or blood pressure after incision, which is an indication of inadequate analgesia ,we supplement 1mcg/kg of fentanyl every hour and these patients are excluded from the study.

·       The infusion of the test drugs are discontinued 10 minutes before the end of the surgery.

·       At the end of the surgery all the anaesthetic agents are discontinued neuromuscular block is reversed with 50mcg/kg neostigmine and glycopyrrolate. Child is extubated when the patient is fully awake.

·       In the post operative anaesthetic care unit the monitoring parameters include

1)SPO2 at every 5 minutes

2)Heart Rate every 5 minutes

3)PEAD score at 0,5,10,15,30,45 minutes

4)FLACC scale at 0,5,10,15,30,45 minutes

(PEAD-Paediatric Anaesthesia Emergence Delirium Scale)

(FLACC-Face, Legs, Activity, Cry, Consolability)

 

·       If PEAD>10,Patient will be administered with 0.03mg/kg midazolam

If FLACC>5,0.5mcg/kg fentanyl is used as a rescue analgesia.

 

 

 
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