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CTRI Number  CTRI/2023/07/054641 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 28/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare the Safety and Efficacy of Sevoflurane and Desflurane for Intraoperative Hemodynamics and Recovery in Pediatric Patients Undergoing Short Surgical Procedures Under spontaneous Respiration. 
Scientific Title of Study   To Compare the Safety and Efficacy of Sevoflurane and Desflurane for Intraoperative Hemodynamics and Recovery in Pediatric Patients Undergoing Short Surgical Procedures Under spontaneous Respiration :A Randomised Prospective study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varanasi Venkata Sri Bharadwaja  
Designation  PG Resident 
Affiliation  Ims and Sum Hospital  
Address  Ims and Sum Hospital Department of Anaesthesiology First floor K8 Kalinga Nagar Khordha District Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  7013599032  
Fax    
Email  bharadwajdoc93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr DAISY KARAN  
Designation  Professor 
Affiliation  Ims and Sum Hospital  
Address  Ims and Sum Hospital Department of Anaesthesiology First floor K8 Kalinga Nagar Khordha District Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  9348417449  
Fax    
Email  daisykaran84@gmail.com  
 
Details of Contact Person
Public Query  
Name  Varanasi Venkata Sri Bharadwaja  
Designation  Pg resident  
Affiliation  Ims and Sum Hospital  
Address  Ims and Sum Hospital Department of Anaesthesiology First floor K8 Kalinga Nagar Khordha District Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  7013599032  
Fax    
Email  bharadwajdoc93@gmail.com  
 
Source of Monetary or Material Support  
Institute of Medical Sciences and Sum Hospital  
 
Primary Sponsor  
Name  Dr Varanasi Venkata Sri Bharadwaja  
Address  Ims and Sum Hospital Department of Anaesthesiology First floor K8 Kalinga Nagar Khordha District Bhubaneswar Odisha India 
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 
Varanasi Venkata Sri Bharadwaja   Institute of Medical Science and Sum Hospital   Ims and Sum Hospital Department of Anaesthesiology , K8,Kalinga Nagar Bhunaneswar, PIN 751003, Khordha District Odisha India.
Khordha
ORISSA 		 7013599032

bharadwajdoc93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE INSTITUTE OF MEDICAL SCIENCES(IMS) AND SUM HOSPITAL   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  Maintenance of Anaesthetia Inhalation Anaesthesic agents Sevoflurane and Desflurane  Patients in the study will be divided in to TWO : 1.Group D Patients will receive DESFLURANE, 2.Group S Patients will receive SEVOFLURANE. Maintainance of anaesthesia: Inhalational 02+n2o+sevoflurane(1-3%) group s ; o2+n2o+desflurane (3-8%) group d and Mac value 1.3 will be maintained through out surgery duration. Haemodynamic parameters (Heart rate and Mean art erial pressure, spo2 ) and the Recovery between Desflurane and Sevoflurane groups in paediatric patients undergoing short surgical procedures(Infra umbilical surgeries) under spontaneous respiration will be noted.  
Comparator Agent  Sevoflurane Desoflurane  Patients in the study will be divided in to TWO : 1.Group D Patients will receive DESFLURANE, 2.Group S Patients will receive SEVOFLURANE. Maintainance of anaesthesia: Inhalational 02+n2o+sevoflurane(1-3%) group s ; o2+n2o+desflurane (3-8%) group d and Mac value 1.3 will be maintained through out surgery duration. Haemodynamic parameters (Heart rate and Mean art erial pressure, spo2 ) and the Recovery between Desflurane and Sevoflurane groups in paediatric patients undergoing short surgical procedures(Infra umbilical surgeries) under spontaneous respiration will be noted. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Patients of age 1- 10 years
Patients under AMERICAN SOCIETY OF ANAESTHESIOLOGISTS (ASA) physical status ASA I and ASA II
Surgery (infra umbilical surgeries)lasting less than one hour duration
Under general anaesthesia with spontaneous respiration
 
 
ExclusionCriteria 
Details  Parents refusal
Patients < 1year or >10 years
Patients under AMERICAN SOCIETY OF ANAESTHESIOLOGISTS (ASA) physical status ASA III and ASA IV
MALLAMPATI GRADING 3 and 4
Surgical duration exceeding 1 hour
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare
1.Hemodynamics(heart rate ,mean arterial pressure,spo2)
2.Recovery Characteristics :
a)Extubation time (the time from discontinuation of anaesthetics to extubation)
b)Emergence time(the time from discontinuation of anaesthetics to achieve the Steward recovery score of 6)
 		 60 minutes
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the airway adverse effects(like cough,laryngospasm,bronchospasm). emergence delirium ,post op nausea and vomiting.  60 minutes  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   15/07/2023 
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="6"
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  

THIS STUDY IS TO COMPARE THE SAFETY AND EFFICACY OF SEVOFLURANE AND DESFLURANE FOR INTRAOPERATIVE HEMODYAMICS AND RECOVERY IN PEDIATRIC PATIENTS UNDERGOING SHORT SURGICAL PROCEDURES UNDER SPONTANEOUS RESPIRATION

AIM :

To compare Haemodynamic parameters (Heart rate and Mean art erial pressure, spo2 ) and the Recovery between Desflurane and Sevoflurane in paediatric patients undergoing short surgical procedures(Infra umbilical surgeries) under spontaneous respiration. 

OBJECTIVE :

PRIMARY OBJECTIVE 

To compare 

1.Hemodynamics(heart rate ,mean arterial pressure,spo2) 

2.Recovery Characteristics :

a)Extubation time (the time from discontinuation of anaesthetics to extubation)

 b)Emergence time(the time from discontinuation of anaesthetics to achieve the Steward recovery score of 6)

SECONDARY OBJECTIVE:

to assess the airway adverse effects(like cough,laryngospasm,bronchospasm). emergence delirium ,post op nausea and vomiting.


METHODOLOGY:


Patients (n= 70) in the study will be divided in to TWO :   

1.Group D Patients will receive DESFLURANE- 35 , 

2.Group S Patients will receive  SEVOFLURANE- 35

A routine pre anaesthetic check up done and adequate fasting guidelines will be followed

 in operation theatre, all standard monitors will be attached & Baseline pulse rate (PR), NIBP, and oxygen saturation (SpO2) will be recorded.

Premedication: IV midazolam 0.03 mg/kg, and IV glycopyrrolate 0.04 µg/kg.

Preoxygenation :for 3min with 100% o2

Induction : iv propofol 2mg/kg and airway secured with adequate size laryngeal mask airway

Maintainance of anaesthesia: 02+n2o+sevoflurane(1-3%) group s ;  o2+n2o+desflurane (3-8%) group d  and  Mac value 1.3 will be maintained through out surgery

Analgesia will be maintained with 20ml/kg i.v paracetmol

Hemodynamic parameters (MAP,HR,SpO2) will be measured every 15mins till completion of surgery. At end all anaesthetic agents will be discontinued 


Emergence time ( time from discontinuation of anaesthetics to extubation) is noted

Recovery time ( time from discontinuation of anaesthetics to achieve the steward score of 6) is noted

THE THREE PARAMETERS OF STEWARD RECOVERY SCORE:

A)consciousness

 b)airway

     c)movement of limbs


Incidence of post operative nausea and vomiting ,if any will be noted 

After extubation , using the paediatric anaesthesia delirium(paed) score at 0, 5, 15, 30, 45, and 60 minutes, emergence delirium is monitered. 

Pacu discharge time(time from receiving patient in pacu from ot till transferring them to ward after achieving modified aldrete score of>9 ) will be noted.

Duration of surgery and anaesthesia will so be noted






 
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