| CTRI Number |
CTRI/2022/06/043327 [Registered on: 17/06/2022] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of anesthesia information before surgery in neurosurgical patients. |
|
Scientific Title of Study
|
Role of Preoperative Anesthesia Counselling in the neursurgical patients: a randomized controlled open label study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
indu kapoor |
| Designation |
Additional Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Neuroanesthesiology and critical care AIIMS New Delhi
E104, Eastern Campus AIIMS DELHI
South
DELHI
110029
India |
| Phone |
09013439134 |
| Fax |
|
| Email |
dr.indu.me@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
indu kapoor |
| Designation |
Additional Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Neuroanesthesiology and critical care AIIMS New Delhi
E104 Eastern Campus Delhi
South
DELHI
110029
India |
| Phone |
09013439134 |
| Fax |
|
| Email |
dr.indu.me@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
indu kapoor |
| Designation |
Additional Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Neuroanesthesiology and critical care AIIMS New Delhi
E 104 Eastern Campsu AIIMS Delhi
South
DELHI
110029
India |
| Phone |
09013439134 |
| Fax |
|
| Email |
dr.indu.me@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Department of Neuroanaesthesiology and Critical Care, AIIMS, New Delhi |
| 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 |
| INDU KAPOOR |
AIIMS |
Department of Neuroanesthesiology and critical care
South
DELHI |
09013439134
dr.indu.me@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ANESTHESIA COUNSELLING |
Patients will be allocated to the AC group, apart from surgical counselling that will receive preoperative anesthesia counselling. For anesthesia counselling, the patients in this group will receive a pre-operative phone call by the primary investigator a day prior to surgery. They will be advised for overnight fasting before the surgery and abstinence from both alcohol and smoking. The patient will be explained about the anesthesia technique that will be administered to them. On day of surgery, 15 minutes before shifting to operation theatre, again patient will be counselled about anesthesia. The patient will be told about their transfer to operation theatre, application of all the routine monitors [also advanced monitor required if any], detail of induction of anesthesia, maintenance of anesthesia and emergence from anesthesia. We will also explain about the transference back to postoperative area after surgery and postoperative care and monitoring of vitals there. |
| Comparator Agent |
STANDARD CARE |
Patients will be allocated to the control group and will receive conventional perioperative care based on institutional practice as described in Appendix 4 Preoperatively patients will be counselled regarding the risk and benefit of the surgery and for abstinence from both alcohol and smoking. Patient will be advised for overnight fasting before the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients [18-65 years] undergoing 2-3 level thoracolumbar spinal fusion surgery
2. Written informed consent
3. American Society of Anesthesiologists class I&II
4. Age of >18 years
5. Either gender
6. Spine pathologies undergoing 2-3 level thoracolumbar spinal fusion surgery
7. Full Glasgow coma score (E4V5M6)
8. Estimated operative time of ≤ 6 hours and anesthesia time of ≤ 8 hours
|
|
| ExclusionCriteria |
| Details |
1. Non consenting patient
2. Mini-Mental State Examination [MMSE] <24
3. Any history of previous brain surgery
4. Current or past history of any cardiac disease or medication
5. Any history of lung disease, liver or kidney dysfunction
6. Body mass index of > 35 kg/m2
7. Preoperative cognitive dysfunction
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Time to emergence [from discontinuation of anesthetics to eye opening on command in minutes]
2. Extubation time [from discontinuation of anesthetics to tracheal extubation in minutes]
|
At the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Postoperative delirium [assessed using CAM-ICU] |
60 minutes after extubation |
| 2. Postoperative early cognitive dysfunction [assessed using MMSE] |
60 minutes after extubation |
| 3. Patients satisfaction score [6-point Likert scale with a score ranging from 0 to 5] |
60 minutes after extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2022 |
| Date of Study Completion (India) |
30/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
There has been an increased interest on the patient’s perioperative course to improve overall outcome while undergoing surgery under general anesthesia. Hospitalization is a painful process which disturbs the physical and psychological wellbeing of the patient. [1] Studies have shown that lack of preparation for surgery, postoperative symptomology, and negative thoughts and beliefs are significantly associated with psychiatric morbidities. [2] Keeping this in mind many enhanced recovery after surgery [ERAS] protocol for various surgical procedures have been introduced in the past. [3-8] Preoperative counselling has been part of many of these ERAS protocols, but little has been discussed about it in detail as to how counselling can improve patients experience during perioperative period. Anesthesia being an integral part of any surgical procedure, its preoperative counselling has never been part of any of these ERAS protocols. It is forlorn to find that apart from surgical counselling, this additional counselling has been given less importance. According to World health Organization [WHO] Global Health Estimate, tens of millions of patients undergo general anesthesia (GA) across the world every year. [9] That makes it more important to emphasise that preoperative anesthesia counselling should be done in every patient who undergoes surgery under general anesthesia. This study aims to evaluate the effect of preoperative counselling regarding anesthesia technique and its impact on postoperative recovery. |