| CTRI Number |
CTRI/2021/02/031091 [Registered on: 08/02/2021] Trial Registered Prospectively |
| Last Modified On: |
05/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pre-operative anxiety and its effects on peri-operative hemodynamic parameters in adult patients undergoing elective surgery under general anaesthesia |
|
Scientific Title of Study
|
Evaluation of effects of pre-operative anxiety on peri-operative hemodynamic parameters in adult patients undergoing elective laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ira Sharma |
| Designation |
Post Graduate MD Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
6375177683 |
| Fax |
|
| Email |
ira94sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suniti Kale |
| Designation |
Consultant and Professor and Guide |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9810287852 |
| Fax |
|
| Email |
findsuniti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suniti Kale |
| Designation |
Consultant and Professor and Guide |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9810287852 |
| Fax |
|
| Email |
findsuniti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi- 110029, India |
|
|
Primary Sponsor
|
| Name |
Ira Sharma |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi- 110029, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Suniti Kale |
Safdarjung Hospital |
Room No. 10,Department of Anaesthesia and Intensive Care,Division- Ground Floor, Main OT building, Vardhman Mahavir Medical College, Ansari Nagar, New Delhi- 110029, India
South
DELHI |
9810287852
findsuniti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The patient subjects are adult patients (18-65 years) of either gender who are American Society of Anesthesiologists (ASA) Grade I and are posted for elective laparoscopic cholecystectomy under general anesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with history of psychiatric illness, treatment with anti depressants and anxiolytics, frequently taking sleeping pills or sedatives.
2. Patients with Central Nervous System diseases.
3. Pregnant patients.
4. Patients with anticipated difficult airway.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate the effect of pre-operative trait anxiety score calculated by State-Trait Anxiety Inventory (STAI) with % change in Mean Blood Pressure during the induction of anaesthesia in adult patients undergoing elective laparoscopic cholecystectomy. |
At the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the effect of pre-operative anxiety score calculated by State-Trait Anxiety Inventory (STAI) with induction hemodynamics (% change in Mean Blood Pressure, Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure) in adult patients undergoing elective laparoscopic cholecystectomy. |
At the end of surgery |
| To correlate the effect of pre-operative anxiety score calculated by State-Trait Anxiety Inventory (STAI) with intra-operative hemodynamics in adult patients undergoing elective laparoscopic cholecystectomy. |
At the end of surgery |
| To correlate the effect of pre-operative anxiety score calculated by State-Trait Anxiety Inventory (STAI) with need for additional propofol dose for induction and intra-operative anesthetic requirement i.e. intra-operative dose of fentanyl in adult patients undergoing elective laparoscopic cholecystectomy. |
At the end of surgery |
| To correlate the effect of pre-operative anxiety score calculated by State-Trait Anxiety Inventory (STAI) with post-operative pain using Visual analogue scale (VAS) score. |
1. At the end of surgery
2. 15 minutes after the end of surgery
3. 30 minutes after the end of surgery
4. 45 minutes after the end of surgery
5. 1 hour after the end of surgery
6. 90 minutes after the end of surgery
7. 2 hours after the end of surgery
8. 150 minutes after the end of surgery
9. 3 hours after the end of surgery
10. 6 hours after the end of surgery
11. 12 hours after the end of surgery
12. 24 hours after the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
05/03/2021 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Through investigator email id ira94sharma@gmail.com
- For how long will this data be available start date provided 01-12-2021 and end date provided 01-12-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a prospective observational cohort study, evaluating the effects of pre-operative anxiety on peri-operative hemodynamic parameters in adult patients undergoing elective laparoscopic cholecystectomy under general anaesthesia in a single centre in India. The primary outcome measure will be correlation of the effect of pre-operative trait anxiety score calculated by State - Trait Anxiety Inventory ( STAI ) with % change in mean blood pressure during the inducion of anaesthesia. The secondary outcomes will be correlation of the effect of pre-operative anxiety score calculated by STAI with - 1. Induction hemodynamics ( % change in mean blood pressure, heart rate, systolic blood pressure, diastolic blood pressure) 2. Intra-operative hemodynamics 3. Need for additional propofol dose for induction and intra-operative anesthetic requirement i.e. intra-operative dose of fentanyl 4. Post-operative pain using Visual Analogue Scale ( VAS ) score. |