| CTRI Number |
CTRI/2020/10/028197 [Registered on: 01/10/2020] Trial Registered Prospectively |
| Last Modified On: |
29/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison between different forms of anesthesia for surgeries in children |
|
Scientific Title of Study
|
POST-OPERATIVE RECOVERY CHARACTERISTICS IN PAEDIATRIC POPULATION - A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devika Anil |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
Kasturba Medical College, Manipal Academy of Higher Education , Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9995176716 |
| Fax |
|
| Email |
drdevikaanil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malavika Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
Kasturba Medical College, Manipal Academy of Higher Education , Manipal
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844241620 |
| Fax |
|
| Email |
malavika.muralidhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Devika Anil |
| Designation |
Junior Resident |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal
Kasturba Medical College, Manipal Academy of Higher Education , Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9995176716 |
| Fax |
|
| Email |
drdevikaanil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal Academy of Higher Education , Manipal |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devika Anil |
Kasturba Medical College |
Department of Anesthesiology, Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA |
9995176716
drdevikaanil@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grades 1 & 2
Elective infra-umbilical superficial surgeries
Duration of surgery less than one hour |
|
| ExclusionCriteria |
| Details |
Categories outside inclusion criteria
Congenital anomalies
Patients whose parents are not willing for the study |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess post-operative recovery characteristics in Post- Anaesthesia Care Unit |
Immediate post-op, 6 hours after surgery and records from medical records department |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate the characteristics in terms of type of anaesthesia technique
Compare the cost aspects of regional anaesthesia alone with general and general with regional |
Immediate post-op, 6 hours after surgery and records from medical records department |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
05/10/2020 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim : To assess and evaluate the post-operative recovery characteristics in paediatric population arriving in PACU after infraumbilical superficial surgeries and to compare them in terms of the quality of anaesthetic technique used. The objectives include to study the following among children undergoing infraumbilical superficial surgeries: 1. Assess the post-operative recovery characteristics in PACU 2. Evaluate these characteristics in terms of the type of anesthetic technique. 3. Compare the cost aspects of regional anaesthesia alone with general anaesthesia & general with regional anaesthesia The study will be conducted in Kasturba Medical College after obtaining clearance from departmental and institutional ethical committee following which the study will be enlisted in the Clinical Trial Registry of India. The study will be conducted over a period of two years from the date of approval. All patients with in the age group of 1-6 years who undergo infraumbilical superficial surgeries, duration of which is within 1 hour who are transferred to the PACU will be included in the study. Informed consent will be taken from the parents of the children. The anaesthesia PACU records of these patients will be accessed from the Medical Records Department, evaluated and data will be recorded. Children will be categorised based on the anaesthetic technique they underwent. Categories will be general anaesthesia, general anaesthesia with regional techniques, and regional anaesthesia alone. The following objective parameters will be obtained from anaesthesia records in Medical Records Department. 1. Blood pressure 2. Saturation(SPO2) 3. Heart rate 4. Level of sedation 5. Peripheral body temperature 6. Pain scores 7. Post-operative vomiting Besides these parameters, the following details also will be noted: 1. Type of anaesthesia received 2. Duration of surgery 3. Rescue analgesia given in PACU 4. Time to restart oral feeds 5. Time to discharge from PACU 6. Time interval from surgery to first voiding 7. Residual weakness in regional techniques 8. Anaesthesia expenses All data will be collected in a pre-designed and pre-tested data extraction sheet by a dedicated postgraduate who is a trainee in department of anaesthesiology. Subsequently, data will be entered in Microsoft excel and exported to SPSS v 16.0 for further statistical analysis. All categorical variables will be expressed as frequencies and percentages and continuous variables in mean and Standard deviation. ANOVA test will be used to study the significance between the recovery characteristics and type of anaesthesia
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