| CTRI Number |
CTRI/2024/11/076289 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on how N-Acetylcysteine reduces cognitive impairment in elderly patients exposed to anaesthesia in day-care surgery |
|
Scientific Title of Study
|
The Effect of N-acetylcysteine in reducing post operative cognitive dysfunction after anaesthesia in elderly patients undergoing day-care surgery |
| 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 MG Rajanandh |
| Designation |
Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Deemed to be University, KTR campus, Chennai- 603203, Tamil Nadu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598464723 |
| Fax |
|
| Email |
mgrpharm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K Anand |
| Designation |
Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
SRM Medical College and Hospital, SRM Institute of Science and Technology, Deemed to be University, KTR campus, Chennai 603203, Tamil Nadu.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
anandk@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR MG Rajanandh |
| Designation |
Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Deemed to be University, KTR campus, Chennai- 603203, Tamil Nadu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598464723 |
| Fax |
|
| Email |
mgrpharm@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, DEPARTMENT OF ANAESTHESIOLOGY |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jaishree M |
SRM Medical College Hospital and Research Center |
Department:Anaesthesia Division:Medical
Chennai
TAMIL NADU |
9344368789
jaishree.mohanbabu040103@gmail.com |
| M Abishek |
SRM Medical College Hospital and Research Center |
Department:Anaesthesia
Division:Medical
Chennai
TAMIL NADU |
7598226877
shekabi487@gmail.com |
| S Sri Harish Kumar |
SRM Medical College Hospital and Research Center |
Department: Anaesthesia
Division: Medical
Chennai
TAMIL NADU |
9566080333
sriharish1007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM IEC |
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 |
N-Acetylcysteine |
Dose: Patients below 50kgs-400mg Patients above 50kgs--
600mg
Duration: Before Anaesthesia- 1 tablet 2 hours before surgery After Anaesthesia- twice daily for 2 days after surgery Administration: Oral
|
| Comparator Agent |
PLACEBO |
Dose: Patients below 50kgs-400mg Patients above 50kgs-600mg
Duration: Before Anaesthesia- 1 tablet 2 hours before surgery After Anaesthesia- twice daily for 2 days after surgery Administration: Oral
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 55 years and older.
-Scheduled for elective daycare surgery under general and spinal anaesthesia.
-Capable of providing informed consent.
-Patients with an American Society of Anaesthesiologists (ASA) physical status classification I-III, indicating they are generally healthy or have mild to moderate systemic disease.
-Patients weighing between 40 kg and 80 kg, to ensure the appropriateness of the NAC dosing regimen.
-Patients undergoing non-cardiac and non-neuro-related surgery.
-Either gender of patients can be included. |
|
| ExclusionCriteria |
| Details |
Known allergy or contraindication to NAC.
-Severe systemic diseases or unstable medical conditions.
-Pre-existing cognitive impairment or neurodegenerative diseases.
-Concurrent participation in another clinical trial.
-Cardiac and neurosurgery patients.
-Undergoing surgery for trauma.
-Lack of the capacity to consent to their surgery.
-Are unable to comply with the requirements of informed consent or the study protocol.
-Subject who participated in any other clinical investigation using an experimental drug in the past 3 months.
-Participants who are not willing to sign the ICF and to attend treatment schedule regularly.
-Pre-existing psychiatric illness such as Alzheimer’s disease, or dementia.
-History or current use of opioid abuse.
-Ortho Surgeries involving upper limbs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of N-Acetylcysteine (NAC) on Postoperative cognitive dysfunction (POCD) in elderly patients undergoing day-care surgery. |
POCD is surveyed with the Mini Mental State Examination (MMSE) at initially 2 hours before surgery as a baseline score, followed by 1 hour after surgery, 6 hours after surgery, 12 hours after surgery, and 24 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To assess the Quality of recovery of Postoperative cognitive dysfunction (POCD) patients undergoing day-care surgery.
•To assess readiness to discharge after N-acetylcysteine administration.
•To monitor and report the Adverse drug reaction (ADR) of N-acetylcysteine if any.
|
Measurement Tool: Standardized Quality of Recovery (QoR) questionnaires (e.g., 40 questionnaires).
Outcome: Change in QoR scores from baseline to postoperative periods in each group. Discharge readiness: Using Modified Aldrete Score of score 9 or above.
|
|
|
Target Sample Size
|
Total Sample Size="296"
Sample Size from India="296"
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)
|
08/11/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|
Participants in this study will be divided into
two groups:
-Group 1: If
you are in this group, you will receive 400-600 mg of NAC orally before your
surgery.
After the surgery, you will continue to take
400-600 mg of NAC orally twice daily for two days.
-Group 2: If
you are in this group, you will receive a placebo treatment, which serves as
abenchmark for comparison.
We will assess your cognitive function using the
Mini Mental State Examination (MMSE) at various time points: 2 hours before
surgery (as a baseline score), 1 hour after surgery, 6 hours after surgery,
12 hours after surgery, and 24 hours after surgery. This helps us understand
how your cognitive function may change over time.
In addition to cognitive assessments, we will
carefully evaluate your recovery using the Modified
Aldrete Score (MAS) to determine your readiness
for discharge from the post-anesthesia care unit (PACU). The MAS considers
key recovery indicators such as activity, respiration, circulation,
consciousness, and oxygen saturation. A score of 9 or higher usually
indicates that you are ready to be discharged.
|
We
will also take into account your overall Quality of Recovery (QOR), which
includes aspects such as physical comfort, emotional well-being, and overall
satisfaction with your recovery process. This comprehensive assessment ensures
that your recovery is thoroughly evaluated not only in terms of physical health
but also in terms of your overall experience. |