| CTRI Number |
CTRI/2023/07/055703 [Registered on: 26/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of same versus different anaesthesiologist on preoperative visits on preoperative anxiety & quality of recovery |
|
Scientific Title of Study
|
Evaluation & comparison of the effect of same versus different anaesthesiologist on preoperative visits on preoperative anxiety & quality of recovery- a randomized controlled trial |
| 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 Vinesh Meena |
| Designation |
Postgraduate student |
| Affiliation |
University college of medical sciences |
| Address |
Department of Anaesthesiology and Critical Care, University College of Medical sciences and GTB Hospital, Delhi-110095
East
DELHI
110095
India |
| Phone |
8882397472 |
| Fax |
|
| Email |
vineshmeena.kv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali T Chilkoti |
| Designation |
Professor |
| Affiliation |
University college of medical sciences |
| Address |
Department of Anaesthesiology and Critical Care, University College of Medical sciences and GTB Hospital, Delhi-110095
East
DELHI
110095
India |
| Phone |
9711210772 |
| Fax |
|
| Email |
geetanjalidr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali T Chilkoti |
| Designation |
Professor |
| Affiliation |
University college of medical sciences |
| Address |
Department of Anaesthesiology and Critical Care, University College of Medical sciences and GTB Hospital, Delhi-110095
East
DELHI
110095
India |
| Phone |
9711210772 |
| Fax |
|
| Email |
geetanjalidr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Main ICU, Second Floor,University College of Medical Sciences and GTB Hospital |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and GTB hospital |
| Address |
Department of Anaesthesia and critical care, University college of medical sciences and GTB hospital |
| 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 |
| Vinesh Meena |
University College of Medical Sciences and GTB Hospital |
GTB Hospital, ICU Department, 2nd Floor, Dilshad Garden, DELHI 110095
East
DELHI |
8882397472
vineshmeena.kv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research |
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 |
| Comparator Agent |
Group - D |
Patient will be attended by the different anaesthesiologist on both preoperative visits i.e. in ward a day prior to surgery and on morning of surgery.During both the visits, the anaesthesiologist will assess Pre operative anxiety utilizing Amsterdam Preoperative Anxiety and Information Scale (APAIS).Patients will receive GA (General Anaesthesia) as per standard protocol. In postoperative period pain will be assessed via a Numeric rating scale-Pain (NRS-P) score at the end of 1st, 3rd,6th, 12th and 24th hour after completion of surgery, Time to reach Modified Aldrete Score ≥9 in post anaesthesia care unit, Patient satisfaction to anaesthesia using Likert scale will be assessed just before shifting the patient from post anaesthesia care unit and Quality of Recovery at the end of day one of surgery using QoR-15 questionnaire. |
| Intervention |
Group-S |
Patient will be attended by the same anaesthesiologist on both preoperative visits i.e. in ward a day prior to surgery and on morning of surgery for pre anaesthestic checkup. During both the visits, the anaesthesiologist will assess Pre operative anxiety using Amsterdam Preoperative Anxiety and Information Scale (APAIS).Patients will receive GA (General Anaesthesia) as per standard protocol. In postoperative period pain will be assessed via a Numeric rating scale-Pain (NRS-P) score at the end of 1st, 3rd,6th, 12th and 24th hour after completion of surgery, Time to reach Modified Aldrete Score ≥9 in post anaesthesia care unit , Patient satisfaction to anaesthesia using Likert scale will be assessed just before shifting the patient from post anaesthesia care unit and Quality of Recovery at the end of day one of surgery using QoR-15 questionnaire. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Consenting female patients between 18-60 years of age undergoing laparoscopic cholecystectomy under General Anaesthesia will be assessed for eligibility and included in the study. |
|
| ExclusionCriteria |
| Details |
History of past surgeries, was exposed to theatre environment prior, mental illness and inability to comprehend questionnaires. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre-operative anxiety of the patients will be assessed using APAIS score |
APAIS score will be assessed day prior to surgery in ward during pre anaesthetic checkup i.e. baseline and on the morning of surgery before starting of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Postoperative pain will be assessed via a Numeric Rating Scale for Pain (NRS-P).
2.Time to reach Modified Aldrete score ≥ 9.
3.Patient satisfaction to anaesthesia by using Likert scale.
4.Quality of Recovery using QoR-15 questionnaire. |
1.Postoperative pain will be assessed via a Numeric Rating Scale for Pain (NRS-P) rated at the end of 1st, 3rd,6th, 12th & 24th hour after completion of surgery.
2.Time to reach Modified Aldrete score ≥9 in post anaesthesia care unit.
3.Patient satisfaction to anaesthesia by using Likert scale will be assessed just before shifting the patient from PACU (Post Anaesthesia Care Unit).
4.Quality of Recovery at the end of day 1 of surgery using QoR-15 questionnaire.
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| 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
|
Preoperative anxiety is common among the patients going for elective surgeries. Various pharmacological and non- pharmacological methods are employed to prevent it. Non pharmacological approaches are gaining popularity as pharmacological interventions have the potential to have negative side effects, such as respiratory issues, drowsiness, interacting with anaesthetic medications and extended recovery. The objectives are to assess and compare the pre-operative anxiety using APAIS score a day prior to surgery in ward and morning of surgery , Quality of recovery using QoR-15 questionnaire at the end of day one of surgery, NRS- P (Numeric Rating Scale for Pain) at 1st ,3rd ,6th ,12th ,24th hours after completion of surgery, Time to reach Modified Aldrete Score ≥ 9, Patient satisfaction score using Likert scale This Randomized controlled trial study includes 90 female patients between 18-60 years of age undergoing laparoscopic cholecystectomy under general Anaesthesia. Patients will be randomized into one of the two groups, a day before surgery Group-D (Control group)- Different anaesthesiologists on both preoperative visits Group- S (Intervention Group)- Same anaesthesiologists on both preoperative visits During both the visits, the anaesthesiologist will assess POA utilizing Amsterdam Preoperative Anxiety and Information Scale (APAIS). Patients in both the groups will receive GA (General Anaesthesia) as per standard protocol. In postoperative period pain will be assessed via a Numeric rating scale-Pain (NRS-P) score at the end of 1st, 3rd,6th, 12th and 24th hour after completion of surgery, Time to reach Modified Aldrete Score ≥9, Patient satisfaction using Likert scale and Quality of Recovery at the end of day one of surgery using QoR-15 questionnaire.
The primary outcome is comparison between APAIS Scores , QoR-15 score, NRS-Pain scores at different time points, Time to reach MAS≥ 9, Patients satisfaction score |