| CTRI Number |
CTRI/2024/05/067469 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Salivary alpha amylase and its relationship with preoperative anxiety in children who are undergoing an elective surgery. |
|
Scientific Title of Study
|
Correlation of salivary alpha amylase and preoperative anxiety in children scheduled for elective surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMYAK JAIN |
| Designation |
Postgraduate student |
| Affiliation |
Government Medical college and Hospital, sector 32-B, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level-5, Government Medical college and Hospital, sector 32-B,
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8750669292 |
| Fax |
|
| Email |
drsamyakjain12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Saroa |
| Designation |
Professor |
| Affiliation |
Government Medical college and Hospital, sector 32-B, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level-5, Government Medical college and Hospital, sector 32-B,
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Palta |
| Designation |
Professor and Head |
| Affiliation |
Government Medical college and Hospital, sector 32-B, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level-5, Government Medical college and Hospital, sector 32-B,
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Sector-32, Chandigarh, India, 160030 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care GMCH Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block- D, Level 5, Government Medical college and Hospital, Chandigarh, India, 160030 |
| Type of Sponsor |
Government medical college |
|
|
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 Samyak Jain |
Government Medical college and Hospital, Chandigarh |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Chandigarh, 160030
Chandigarh
CHANDIGARH |
8750669292
drsamyakjain12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Age 2-9 years of either gender
ASA – I and II
Type of surgery – elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Refusal of parents/ guardians to take part in the study
children with any orofacial deformities like Treacher collin syndrome, aplasia of salivary glands, ranula
children with neurological/ neurodeveopemental disorder
children undergoing emergency surgery
children who have undergone surgery more than 2 years of age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the correlation of levels salivary alpha amylase (sAA) with
preoperative anxiety in children scheduled for elective surgery |
1 day before surgery, 30 minutes before induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Correlation of Salivary Alpha Amylase with Induction Compliance Checklist Score
2. Correlation of Salivary Alpha Amylase with modified Yale Preoperative anxiety Scale one day before the surgery
3. Assessment of Salivary Alpha Amylase as a predictor of preoperative anxiety in children |
1 day before surgery, 30 minutes before induction, at induction |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/06/2024 |
| 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="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
|
Children posted for any surgical procedure may have
unpleasant sensations of nervousness, apprehension and fear. Preoperative anxiety
causes various physiological changes in the
body. The increasing levels of salivary alpha amylase is one of them.This
preoperative anxiety is associated with poor induction outcomes like
prolonged anaesthesia time, increased recovery time. Managing it
on time and identifying children at risk can improve the induction
outcome. Currently there are subjective methods to assess the level of
preoperative anxiety in children like the Modified Yale Preoperative Anxiety
Scale (mYPAS), but not any objective one. So, this study is planned to
assess if salivary alpha amylase levels can correlate with the levels of
preoperative anxiety in children.
The present study will be conducted in the Department of
Anaesthesia and Intensive Care, Government Medical College and Hospital,
Chandigarh-32. A total of 45 children of either sex, aged 2-9 years, undergoing
elective/scheduled surgeries under general anaesthesia will be enrolled after
obtaining written informed consent.
Study design-Prospective, cohort study
Sample size (N)= [(Zα+Zβ)/C]2 + 3. Assuming
90% power and 95% confidence interval, the proposed sample size for the study
is 38. Accounting for a 20% dropout, a sample size of 45 has
been kept.
One day prior to study: A complete pre
anaesthetic evaluation will be done. A written informed consent will
be taken from the parents/guardians and assent from children more than 7 years
of age.At this time mYPAS will be calculated. Children and their
parents will be explained the method of sample collection. Sample will be
collected by cotton swab/ 2 cc syringe/mucus extractor one day prior at a
minimum of 1hour after last meal (T0).
On the day of surgery:The mYPAS of
the child will be noted(T1) in the preoperative area. The second sample
of saliva will be taken. After the sample is taken oral Midazolam
0.3mg/kg will be given 30 minutes before induction.During induction, the method
of induction (IV/inhalational) will be noted. The video of the child will be
made and his ICC score will be noted. Then the surgery will be allowed to
proceed as per standardised institutional protocol.
All the observations will be noted in the prescribed proforma and will
be subjected to appropriate statistical tests to draw inferences between
salivary alpha amylase and preoperative anxiety in children
|