| CTRI Number |
CTRI/2021/09/036412 [Registered on: 10/09/2021] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Comparison of Analgesia Nociception Index (ANI) guided opioid administration on postoperative pain score, opioid requirement and stress response in children undergoing cochlear implant surgery
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Scientific Title of Study
|
Effect of perioperative Analgesia Nociception Index (ANI) guided opioid administration on postoperative pain score, opioid consumption and endocrine stress response in paediatric patients undergoing cochlear implant surgery: a prospective randomized controlled trial
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| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajeshwari Subramaniam |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS, Ansari nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810079229 |
| Fax |
|
| Email |
drsrajeshwari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajeshwari Subramaniam |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS, Ansari nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810079229 |
| Fax |
|
| Email |
drsrajeshwari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gajalakshmi Sanjeevi |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS, Ansari nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7904299501 |
| Fax |
|
| Email |
drgajalakshmi97@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology, Pain medicine and Critical care, Ansari nagar, New Delhi |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rajeshwari Subramaniam |
AIIMS, New Delhi |
Department of Anaesthesiology , pain medicine, critical care, Ansari nagar, New Delhi
New Delhi
DELHI |
9810079229
drsrajeshwari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Analgesia Nociception Index tool guided opioid administration |
IV fentanyl 1mcg/kg will be administered when mean ANI value is less than 50 and repeated every 5 minutes until it is more than 50 |
| Comparator Agent |
Hemodynamic parameters guided opioid administration |
IV fentanyl 1mcg/kg will be administered when heart rate and/or blood pressure is more than 20 percent of baseline |
|
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Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1 and 2
2.Scheduled for elective cochlear implant
|
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| ExclusionCriteria |
| Details |
1.Severe cardiac/respiratory disease
2.Parental refusal
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether use of Analgesia Nociception Index (ANI) guided perioperative opioid administration results in decrease in FLACC scale score postoperatively |
from the start of surgery to upto 90 minutes in post anaesthesia care unit |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To compare ANI-guided vs hemodynamic parameter guided opioid administration on:
1.Total fentanyl consumption
2.Endocrine stress response during surgery
3.Incidence of emergence delirium |
from the start of surgery to upto 90 minutes in post anaesthesia care unit |
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Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
10/09/2021 |
| Date of Study Completion (India) |
03/10/2022 |
| 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
|
NOT YET |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The assessment of pain in children for safe, optimal and effective analgesia is a challenging task. Advances in analgesia monitoring may manage pain objectively in children. Opioid administration based on hemodynamics and clinical signs may lead to under dosage or over dosage and result in side effects like intraoperative movement, postoperative pain, postoperative nausea and vomiting, and respiratory depression. Recent studies suggested that ANI is more sensitive to detect surgical stimuli during surgery and useful for monitoring intraoperative analgesia than the other hemodynamic parameters.Thus, we hypothesise that in comparison to hemodynamic parameters guided perioperative opioid administration, ANI guided management will result in favourable pain scores postoperatively, less increase in surgery-related stress hormones and decrease in the incidence of emergence delirium in children undergoing cochlear implant surgery. After preanaesthesia check up and obtaining consent, child will be shifted to operation theatre on the day of surgery. After noting baseline hemodynamic parameters, general anaesthesia will be administered in both the groups. In the control group, IV fentanyl 1mcg/kg will be administered when HR and/or BP is more than 20 percent of baseline and repeated until it reaches baseline. In the ANI group, IV fentanyl 1mcg/kg will be administered when mean ANI >50 and repeated every 5 minutes until it is <50. Blood samples will be collected before and at the end of surgery. The child will be monitored in post anaesthesia care unit for 90 minutes. During those 90min, we will record the FLACC scores, amount of fentanyl administered, incidence of emergence delirium using the PAED scale, and other side effects like nausea and vomiting, shivering and respiratory depression every 10 minutes. If the PAED score is more than10, IV midazolam 0.1mg/kg will be administered. Children will be discharged when the Modified Aldrete Score reaches more than 9. |