| CTRI Number |
CTRI/2017/11/010649 [Registered on: 27/11/2017] Trial Registered Prospectively |
| Last Modified On: |
25/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of anxiety on propofol induced decrease in blood pressure in children undergoing elective surgery |
|
Scientific Title of Study
|
Impact of preoperative anxiety on propofol induced hypotension in children undergoing elective surgery under general anaesthesia. 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 |
Puneet Khanna |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 5007
5th Floor
Teaching Block
AIIMS
Ansari Nagar
New Delhi
110029
South
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Khanna |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 5007
5th Floor
Teaching Block
AIIMS
Ansari Nagar
New Delhi
110029
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Khanna |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No 5007
5th Floor
Teaching Block
AIIMS
Ansari Nagar
New Delhi
110029
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room No-5011
Department of anaesthesiology
Teaching block
AIIMS New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Room No-5011, 5th floor, Teaching block, AIIMS, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Puneet Khanna |
AIIMS New Delhi |
Room No 5011
5th Floor
Teaching Block
AIIMS
Ansari Nagar
New Delhi
110029
South
DELHI |
9873106516
k.punit@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children undergoing elective surgery under general anaesthesia induced with propofol, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
The study will be conducted on 100 children in age group of 3-12 years, ASA grade I and II, undergoing elective day care surgeries.
|
|
| ExclusionCriteria |
| Details |
Emergency surgery,
child with developmental delay,
age <3 years and >12years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the prevalence of preoperative anxiety in children of Indian population prior to surgery.
To assess the effect of preoperative anxiety on arterial pressure changes after induction with
propofol.
|
Every minute after anaesthesia induction with propofol till 10th minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcomes are studied |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/01/2018 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. DREGER VA,
TREMBECK TF: Management of perioperative anxiety in children. AORN Journal;
2006,84(5):788-804.
2. Fortier MA, Del Rosario AM, Martin SR,
Kain ZN. Perioperative anxiety in children. Paediatr Anaesth. 2010;20:318-322.
3. Kain ZN, Wang SM, Mayes LC, Caramico LA,
Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioural
outcomes. Anesth Analg. 1999;88:1042-1047.
4. Kain ZN, Mayes LC, Caldwell-Andrews AA,
Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral
recovery in young children undergoing surgery. Pediatrics. 2006;118:651-658.
5. Reves JG, Glass P, Lubarsky DA.
Miller’s Anesthesia. 7 Churchill Livingstone; Philadelphia:2010. Intravenous
Anaesthetics.
6. Roth
W, Dobrenz S, Dietal A, et al. Sympathetic activation in broadly defined
generalized activation anxiety disorder. J Psychiatr Res. 2008;42:205-12.
7. Hanss
R, Bein B, Ledowski T, et al. Heart rate variability predicts severe
hypotension after spinal anesthesia foe elective caesarean delivery.
Anesthesiology.2005;102:1086-93.
8. Morley AP,
Papageorgiou CH, Marinaki AM, Cooper DJ and Lewis CM. The effect of
pre-operative anxiety on induction of anaesthesia with propofol. Anaesthesia
2008; 63(5):467-473.
9. Kain ZN, Mayes LC, Cicchetti DV,
Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how
does it compare with a “gold standard� Anesth Analg. 1997;85:783-788.
|