FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093880 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral
Other (Specify) [Cross sectional clinical Trial]  
Study Design  Other 
Public Title of Study   The impact of the caregiver’s voice on irritability, inconsolability and disorientation seen in children recovering from general anaesthesia and comparing it to the effect of the anaesthesiologists voice: A prospective randomized control trial 
Scientific Title of Study   The impact of the caregiver’s voice on emergence delirium in children: A prospective randomized control 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  Cyriac Gerard Sebastian 
Designation  Post graduate 
Affiliation  St. Johns Medical College and Hospital, Bangalore 
Address  Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034

Bangalore
KARNATAKA
560034
India 
Phone  09449570871  
Fax    
Email  cyriac.g.sebastian@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anjali Teresa Mathew Ollapally 
Designation  Associate Professor 
Affiliation  St. Johns Medical College and Hospital, Bangalore 
Address  Department of Anesthesia and Critical Care St. Johns Medical College and Hospital.Sarjapura Road Koramangala Bengaluru-560034

Bangalore
KARNATAKA
560034
India 
Phone  9886474530  
Fax    
Email  dr.anjaliollapally@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anjali Teresa Mathew Ollapally 
Designation  Associate Professor 
Affiliation  St. Johns Medical College and Hospital, Bangalore 
Address  Department of Anesthesia and Critical Care St. Johns Medical College and Hospital.Sarjapura Road Koramangala Bengaluru-560034

Bangalore
KARNATAKA
560034
India 
Phone  9886474530  
Fax    
Email  dr.anjaliollapally@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Critical Care St. Johns Medical College and Hospital. Bengaluru-560034 
 
Primary Sponsor  
Name  St. Johns Medical College and Hospital 
Address  Room no 7 OT Complex, 2nd floor, St. Johns Medical and Hospital, Sarjapur-Marathahalli Rd,beside Bank of Baroda, John Nagar, Koramangala Bengaluru-560034 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Cyriac Gerard Sebastian  St. Johns Medical College and Hospital, Bangalore  Room No. 7 OT Complex, 2nd floor St. Johns Medical College and Hospital Sarjapura road Koramangala Bengaluru-560034
Bangalore
KARNATAKA 
09449570871

cyriac.g.sebastian@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,St. Johns Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Anesthesiologists recorded voice  Children in Group A will listen to the Anaesthetists recorded voice using noise cancelling headphones at the end of the surgery till they reach the recovery room.The duration of the intervention will be approximately 20-30 minutes 
Intervention  Caregivers recorded voice  Children in Group C will listen to their caregivers recorded voice using noise cancelling headphones at the end of the surgery till they reach the recovery room.The duration of the intervention will be approximately 20-30 minutes 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists (ASA) physical status -I-II 
 
ExclusionCriteria 
Details  Presence of neurological/psychiatric diseases
Bilateral Deafness or hearing impairment in the child
Mutism in Caregiver 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of the caregiver’s and the anaesthesiologist’s voice on emergence delirium  We will be assessing this by measuring the different scores at the time of entering the pacu and every 10 minutes for 30 minutes post entering the PACU 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of emergence delirium
2. Time taken for extubation
3. Analgesic requirement in the recovery room/PACU

 
From the end of the surgery till 10 minutes after reaching the recovery room. 
 
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   Phase 4 
Date of First Enrollment (India)   27/09/2025 
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="2"
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  

             Introduction

 

Emergence delirium (ED) is an acute brain dysfunction during recovery from general anesthesia. It can be complicated by varying levels of consciousness and encompasses disruptive behaviors that almost always require intervention during the postoperative period.

Pediatric emergence delirium (paedED)is seen most commonly in children between the ages of 2- 8 years and may present with purposelessness, disorientation, decreased awareness of surrounding, staring or averting of eyes from caregivers and inconsolability.

PaedED continues to be a matter of concern in perioperative care and its varied incidence (2%-80%) is influenced by a wide range of risk factors, including preoperative parental and child anxiety, use of volatile anesthetic, type of surgery and untreated pain.

Children experiencing ED are associated with an increased risk of injuring themselves, their caregivers and their surgical repair, displacing intravenous lines, catheters, drains. ED leads to increased length of stays and constant supervision in post-anesthesia care unit (PACU), which puts a strain on healthcare resources indicating the need for better preventive and curative measures. In addition, it was seen that children with PaedED were 1.43 times at greater risk of having long term maladaptive behavioral changes.

Pharmacological methods like alpha 2 agonists(dexmedetomidine), opioids, melatonin, midazolam, ketamine and magnesium, when used in conjunction with volatile anesthetics have been shown to reduce the incidence and severity of emergence delirium. However, children may experience side effects such as hypotension, bradycardia, sedation with the use of these medications.

Emergence delirium in children has also been addressed using non pharmacological approaches. Some of these methods include parental presence, cartoons, handheld video games during induction, and have proven to be comparable to medications in reducing the incidence of ED 

Studies have shown that listening to a mother’s voice postoperatively reduces emergence delirium compared to those hearing a stranger’s voice, suggesting a comforting role of familiar voices.

However, since the mother may not always be present or the primary caregiver, we chose to examine the impact of the closest caregiver’s voice on emergence delirium.

Methodology:

 

The children who fulfill the inclusion criteria and are posted for elective surgery will be screened for the study. Informed consent will be taken from the parent. For children aged 7-8 years, assent will be obtained in addition to the parental consent. We will explain the study in an age-appropriate language, using simple verbal explanations or visual aids (pictures and headphones).The child’s agreement will be documented on an assent form. For children between 2-6 years, formal assent is not required but we will explain the study in an age-appropriate manner to ensure the child’s comfort and to minimize distress. A thorough Pre-anesthetic checkup (PAC) will be done one day prior to the proposed surgery. The patient will be kept nil per oral for 6 hours pre operatively for solids, and 2 hours for clear fluids, as per existing fasting guidelines.

 

On the day of the surgery, randomisation and voice recording will be done by an independent assessor who is an anaesthesiologist. The anaesthesiologist in the OT will be blinded to the group allocation and will perform the study. The caregiver and the anesthesiologist (independent assessor) will be asked to speak the following sentences in their usual tone of voice and in the language that is spoken/understood by the child. “Wake up (name of the child). Open your eyes, breathe well. Wake up, (name of the child) It is time to go home. Wake up (name of child).”

 

The participants will be randomized to one of two groups with a 1:1 ratio-Group C participants will be made to listen to the recorded voice of the caregiver and Group A will be made to listen to the recorded voice of the

Anesthesiologist. The randomization will be done using the random number generator tool available on Google. In case an odd number is generated the participant will be part of Group A and if an even number is generated, the participant will be part of Group C.

 

We will assess the preoperative anxiety in the child in the pre-op area using the modified Yale preoperative anxiety scale for children (m-YPAS). We calculate the m-YPAS score by dividing each domain score by the highest possible score (i.e., 6 for the “vocalizations” domain and 4 for all other items), add all of the produced values, divide by 4, and multiply by 100. This produces a score ranging from 22.92 to 100, with higher values indicating greater anxiety.

After entering the operating theatre, standard monitoring equipment (non-invasive arterial blood pressure, electrocardiography, heart rate, pulse oximetry and end tidal CO2) will be connected to the patient. Baseline recording will be noted.

 

Premedication will be administered with Glycopyrrolate 10mcg/kg IV. Ondansetron 0.15mg/kg IV and midazolam 0.03 mg/kg IV. Anesthesia will be induced with Inj. Fentanyl 2mcg/kg. Propofol 2mg/kg IV. Atracurium(0.5 mg/kg IV)will be administered and ventilation will be done with a bag and mask for 3 minutes. This will be followed by direct laryngoscopy and intubation with an appropriate-sized Macintosh blade and endotracheal tube respectively. Anaesthesia will be maintained on 50% air-oxygen mixture and sevoflurane titrated and kept to MAC between 1.0 and 1.2. Regular intervals of Atracurium (0.1mg/kg IV) will be given to maintain neuromuscular blockade.In case of infra umblical surgeries, caudal analgesia with 0.25% Bupivacaine(1ml/kg) will be given.Intermittent Fentanyl boluses(0.5 mcg/kg) will be given for all other surgeries. Paracetamol 10mg/kg will also be given IV for all surgeries for analgesia.

 

The recorded voice of the caregiver (Group C) or the anaesthesiologist( Group A) will be delivered through

noise cancelling headphones at the end of the surgery and will be repeated every 20 seconds until the patient

has entered the PACU. The volume will be set to a normal speech level and the patient will be stimulated to

wake up by lightly patting on the shoulder. No other stimulation is allowed.

 

The effect of Atracurium will be reversed using Neostigmine (0.05 mg/kg IV) and Glycopyrrolate (10 mcg/kg IV) and the oral cavity secretions will be gently suctioned and the child will be extubated once the extubation criteria has been met.

 


 
Close