| CTRI Number |
CTRI/2024/10/075487 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the anxiety of the patient before the surgery and the impact that it has in the outcome after the surgery. |
|
Scientific Title of Study
|
Evaluation of effect of pre-operative Anxiety in Pre-Anesthetic Clinic on Post-operative outcome-An Observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yoganathan Rajasekaran |
| Designation |
M.D.Anesthesia -Postgraduate |
| Affiliation |
sri venkateshwaraa medical college hospital and research centre |
| Address |
Room no.211,dept of anesthesia ot complex,jr quaters division ,Sri
Venkateshwaraa Medical College Hospital and Research
Centre,No.13-A,Pondy-Villupuram Main Road, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9943646733 |
| Fax |
|
| Email |
Yoganathanjojack55555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishnaprabu |
| Designation |
Professor & HOD |
| Affiliation |
sri venkateshwaraa medical college hospital and research centre |
| Address |
Dept of anesthesia, OT complex, Sri Venkateshwaraa Medical
College Hospital and Research Centre,No.13-A,Pondy-Villupuram
Main Road, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishnaprabu |
| Designation |
Professor & HOD |
| Affiliation |
sri venkateshwaraa medical college hospital and research centre |
| Address |
Dept of anesthesia, OT complex, Sri Venkateshwaraa Medical
College Hospital and Research Centre,No.13-A,Pondy-Villupuram
Main Road, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Medical College Hospital and Research Centre,No.13-A,Pondy-Villupuram main road,ariyur,puducherry,India,605102 |
|
|
Primary Sponsor
|
| Name |
Yoganathan Rajasekaran |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre,No.13-A,Pondy-Villupuram main road,ariyur,puducherry,India,605102 |
| Type of Sponsor |
Other [self[principal investigator]] |
|
|
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 Yoganathan Rajasekaran |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
Department of
Anesthesiology,ot
complex,ortho
division,room
no.8,Pondy-Villupuram
Main Road, Ariyur,
Puducherry,
PONDICHERRY
Pondicherry
PONDICHERRY |
9943646733
yoganathanjojack55555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human studies) |
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 |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient planned for elective surgery under general anaesthesia.
ASA-I,II,III patients. |
|
| ExclusionCriteria |
| Details |
Patient refusal,
Patient underwent surgery under anaesthesia within the preceding 1year,
Psychiatric and pediatric age group patient. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the preoperative anxiety and postoperative pain,nausea, vomiting scores |
Immediate Postoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing the patient anxiety by giving comprehensive information and measuring using VAS-A scale,APAIS score and PONV scale. |
On the night before surgery,
On the morning of surgery,
1hr after postoperative period. |
|
|
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)
|
14/11/2024 |
| 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
|
* By analysing the anxiety level using VAS-A scale and APAIS scale; higher the level of anxiety in pre-anesthetic clinic, higher the incidence for nausea, vomiting and postoperative pain.so,by giving comprehensive information in pre-anesthetic clinic about anesthesia, surgical procedure and postoperative period will limit the anxiety level. *By reassessing the patient 1-hour post-operatively;if nausea, vomiting, postoperative pain increases,then the premedication dose of anxiolytics and anti-emetics is not adequate.Increase in dosage of T.alprox&T.emeset is suggested.50mg Tramadol is suggested for increasing in pain |