| CTRI Number |
CTRI/2024/12/077945 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomised controlled trial to study the effect of family members recorded voice during recovery from general anesthesia on emergence delirium in elderly patients |
|
Scientific Title of Study
|
Effect of family members recorded voice during recovery from general anaesthesia on emergence delirium in elderly patients A randomised 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 Rucha Akash Bandegiri |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care,
3rd floor, Emergency Block, Near Adult ICU,
All India Institute of Medical Sciences Basni Phase-II, Jodhpur, Rajasthan, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7359266870 |
| Fax |
|
| Email |
ruchabandegiri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamlesh Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care,
3rd floor, Emergency Block, Near Adult ICU,
All India Institute of Medical Sciences Basni Phase-II, Jodhpur, Rajasthan, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9780040150 |
| Fax |
|
| Email |
kamlesh.gmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamlesh Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care,
3rd floor, Emergency Block, Near Adult ICU,
All India Institute of Medical Sciences Basni Phase-II, Jodhpur, Rajasthan, India
RAJASTHAN
342005
India |
| Phone |
9780040150 |
| Fax |
|
| Email |
kamlesh.gmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care Medicine,
All India Institute of Medical Sciences Basni Phase-II, Jodhpur, Rajasthan, India 342005 |
|
Primary Sponsor
Modification(s)
|
| Name |
AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care Medicine, All India Institute of Medical Sciences (AIIMS), Basni Industrial Area Phase-2, Jodhpur-342005, Rajasthan |
| 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 Rucha Bandegiri |
All India Institute of Medical Sciences Jodhpur |
Department of Anaesthesiology and Critical Care,
3rd floor, Emergency Block, Near Adult ICU,
All India Institute of Medical Sciences Basni Phase-II, Jodhpur, Rajasthan, India
Jodhpur
RAJASTHAN |
7359266870
ruchabandegiri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Listening to family member’s recorded voice during recovery from general anaesthesia |
In a calm environment, the family member will be requested to speak the below mentioned lines in their usual voice tone and in the patients native language for making a recording: ‘OO (name of patient/nickname), wake up. Your operation is complete. You are alright. Let’s go home. OO dear, wake up. Open your eyes. Take a deep breath’
Following the operation, the pre- recorded message will be played at 10-second intervals, with the volume adjusted to typical speech levels (50-60 dB) which will be delivered using the noise-cancelling headphones. After gently suctioning of oral secretions from the oropharynx, extubation will be cautiously conducted once participants can breathe spontaneously and respond to verbal commands. The voice recording will continue to be delivered to the patient until they are transferred to the post-anesthesia care unit (PACU). |
| Comparator Agent |
Listening to stranger’s recorded voice during recovery from general anaesthesia |
In a calm environment, an individual unfamiliar with the patient will be requested to speak the below mentioned lines in their usual voice tone and in the patients native language for making a recording: ‘OO (name of patient/nickname), wake up. Your operation is complete. You are alright. Let’s go home. OO dear, wake up. Open your eyes. Take a deep breath’
Following the operation, the pre- recorded message will be played at 10-second intervals, with the volume adjusted to typical speech levels (50-60 dB) which will be delivered using the noise-cancelling headphones. After gently suctioning of oral secretions from the oropharynx, extubation will be cautiously conducted once participants can breathe spontaneously and respond to verbal commands. The voice recording will continue to be delivered to the patient until they are transferred to the post-anesthesia care unit (PACU).
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Elderly patients more than 65 years belonging to ASA grade 1 or 2 scheduled for elective minimally invasive surgery, under general anaesthesia will be enrolled. Written informed consent will be taken from every patient during pre-operative visits before surgery |
|
| ExclusionCriteria |
| Details |
1.Patients diagnosed with neuropsychiatric disorders, that is, schizophrenia, epilepsy, parkinsons disease, cognitive dysfunction, dementia
2.Patients with language barrier which hinders effective communication and assessment
3.Patients with hearing impairment or deafness
4.Absence of family member
5.History of neurosurgical procedure |
|
|
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 compare incidence of postoperative emergence delirium in PACU in elderly patients |
10 minutes (T1), 30 minutes (T2), and at discharge from the PACU (T3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of postoperative delirium at postoperative Day 1 |
Postoperative Day 1 (POD1) |
| To compare NRS pain scores in the PACU and postoperative Day 1 |
PACU and Postoperative day 1 (POD1) |
| To compare extubation time (duration from cessation of anaesthetic to extubation) |
NA |
| To compare eye opening time (time taken by patient to open his/her eyes from the time of cessation of anaesthetic agent) |
NA |
| To compare duration of PACU stay |
NA |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
Modification(s)
|
30/12/2024 |
| 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="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
|
Delirium in the immediate postoperative period is a commonly encountered complication amongst patients in the PACU posing many immediate challenges and affecting long term outcomes. The incidence of Emergence Delirium (ED) varies greatly based on patient status as well as type of surgery but evidently higher in elderly population as compared to young adults. There is no universally accepted delirium risk prediction tool and opinions on drug-based prophylaxis of ED remain conflicting and there isn’t any conclusive evidence. However, most of the evidence published till date supports the use of non-pharmacological methods to prevent delirium. Amongst others, auditory stimuli are an easy and effective tool and have shown promising results. A clinical trial conducted in the paediatric population has shown that listening to mother’s recorded voice during emergence can reduce ED in children compared with hearing the recorded voice of a stranger. So we have planned an RCT to study the effectiveness of repeated auditory stimulus in the form of a family member’s recorded voice listened to during recovery compared with a stranger’s voice on the incidence of ED after general anaesthesia, especially in the elderly population keeping in mind the higher incidence in this age group. |