| CTRI Number |
CTRI/2024/05/066959 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Quality of Recovery in patients undergoing surgeries on bones/ligaments under anaesthesia at a tertiary level teaching hospital- a cross sectional study. |
|
Scientific Title of Study
|
Quality of Recovery in patients undergoing Orthopedic Sugeries under anaesthesia at a tertiary level teaching hospital- a cross sectional 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 |
Dr Preeti Gehlaut |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Anaesthesiology and Critical Care, Pt B D Sharma PGIMS,Rohtak, Haryana
Rohtak
Haryana, 124001
Rohtak
HARYANA
124001
India |
| Phone |
8950285434 |
| Fax |
|
| Email |
preeti.gehlaut@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lopita Sahu |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak, Haryana |
| Address |
Department of Anaesthesiology and Critical care, Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8018758653 |
| Fax |
|
| Email |
lopitasahu3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lopita Sahu |
| Designation |
Junior Resident |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak, Haryana |
| Address |
Department of Anaesthesiology and Critical care, Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8018758653 |
| Fax |
|
| Email |
lopitasahu3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology and critical care ,Pt B D
Sharma health science, PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS Rohtak Haryana |
| Address |
Department of Anaesthesiology and Critical care,Pt B D Sharma PGIMS, Rohtak, Haryana |
| 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 Lopita Sahu |
Pt. B D Sharma PGIMS Rohtak |
Department of anaesthesiology and Critical care,Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
Haryana
Rohtak
HARYANA |
08018758653
lopitasahu3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bio Medical Research Ethics Committee, Pt B D Sharma PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
QoR-15 questionnaire |
No treatment only administration of questionnaire. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The study will include 250 patients of either sex of age 18-80 years belonging to American Society of Anesthesiologist (ASA) I,II or III patient presenting for elective and semi urgent orthopedic surgery |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients requiring ICU admission in post operative period.
Spine surgery patients
Patients whose surgeries get cancelled due to any reason
patients who are drowsy, disoriented, sedated and unable to understand and communicate normally.
polytrauma patients needing multiple surgeries
amputation surgeries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study and compare the quality of recovery using QoR-15 questionnaire in patients following elective and semi urgent orthopedic surgery.
|
QoR-15 questionnaire on the day before surgery and 24-36 hour after the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To describe the relationship between the QoR-15 score and various factors like;
Anaesthetic factors
Surgical factors
Patient factors |
Pre anaesthetic check up
during post operative period 24-36 hour |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
17/05/2024 |
| 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="0"
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
|
The present cross sectional study will be conducted in the department of anesthesia and critical care , PGIMS Rohtak. Written informed consent will be taken from patients included. Then assessment of Quality of Recovery after Orthopedic surgery in patients. Data will be complied and analyzed appropriate statistical tests. |