| CTRI Number |
CTRI/2022/08/045085 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
29/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between the use of opioid (fentanyl) versus use of non opioid (caudal block with bupivacaine) anaesthesia in neonates undergoing infra umbilical surgeries to determine which technique is better in terms of faster extubation and the degree of analgesia produced |
|
Scientific Title of Study
|
Comparing Opioid Versus Non-Opioid Anaesthesia Technique For Extubation Time In Neonates Undergoing Infraumbilical Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhinav Siroha |
| Designation |
Post Graduate Resident |
| Affiliation |
VMMC And Safdarjung Hospital |
| Address |
Department Of Anaesthesia
VMMC And Safdarjung Hospital Ansari Nagar East New Delhi 110029
South
DELHI
110029
India |
| Phone |
9899201568 |
| Fax |
|
| Email |
wildchildabhinav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHARU BAMBA |
| Designation |
Consultant Professor |
| Affiliation |
VMMC And Safdarjung Hospital |
| Address |
Department Of Anaesthesia
VMMC And Safdarjung Hospital Ansari Nagar East New Delhi 110029
South
DELHI
110029
India |
| Phone |
9811270511 |
| Fax |
|
| Email |
charu.bamba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CHARU BAMBA |
| Designation |
Consultant Professor |
| Affiliation |
VMMC And Safdarjung Hospital |
| Address |
Department Of Anaesthesia
VMMC And Safdarjung Hospital Ansari Nagar East New Delhi 110029
West
DELHI
110029
India |
| Phone |
9811270511 |
| Fax |
|
| Email |
charu.bamba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anesthesia
VMMC And Safdarjung Hospital
Ansari Nagar East
New Delhi 110029
|
|
|
Primary Sponsor
|
| Name |
Dr Abhinav Siroha |
| Address |
Department Of Anaesthesia
VMMC And Safdarjung Hospital Ansari Nagar East New Delhi 110029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
DEPARTMENT OF ANAESTHESIA
VMMC AND SAFDARJUNG HOSPITAL
ANSARI NAGAR EAST NEW DELHI 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhinav Siroha |
Vardhaman Mahavir Medical College And Safdarjung Hospital |
Department Of Anaesthesia
VMMC And Safdarjung Hospital Ansari Nagar East New Delhi 110029
South
DELHI |
9899201568
wildchildabhinav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE VMMC AND SJH |
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 |
| Comparator Agent |
Non-Opioid Anesthesia Technique |
After the baby is shifted to warm operation theatre non-invasive monitoring
including electrocardiography, non-invasive blood pressure and pulse oximetry will be
established. The baby will be preoxygenated.
For group NO(Non-Opioid), after induction with inj. Thiopentone and sevoflurane, patient will be
intubated. Inj. Acetaminophen will be given iv as 7.5 mg/kg body weight. Caudal block
with 0.25% bupivacaine 1ml/kg with upper limit of 2mg/kg will be given. General
anaesthesia will be maintained with oxygen, sevoflurane and atracurium.
At the end of surgery, neuromuscular reversal agents (Neostigmine 50 microgram per kg body weight and Glycopyrrolate 10 micrograms per kg body weight). The
extubation time is measured as the time taken from last skin suture to the tracheal tube
removal and return of protective airway reflexes.
Vital parameters will be strictly monitored during the procedure. In the post-operative
period, the patient’s pain score will be checked and recorded as per NIPS scale at 5th minute
and later every 15 minutes for the first 1 hour, every 30 mins for next 2 hours and thenhourly till total of six hours after extubation. |
| Intervention |
Opioid Anesthesia Technique |
After the baby is shifted to warm operation theatre non-invasive monitoring
including electrocardiography, non-invasive blood pressure and pulse oximetry will be
established. The baby will be preoxygenated. In Group O, inj. Fentanyl at 1mcg/kg iv
loading dose will be given. Induction of general anaesthesia will be with inj.
Thiopentone (5mg/kg body weight) and sevoflurane(inhalation). Under direct laryngoscopy, endotracheal tube of
appropriate size will be inserted and fixed at angle of mouth according to the precalculated
depth. Placement will be confirmed by auscultation. General anaesthesia will be maintained on oxygen,
sevoflurane and inj. Atracurium(0.3mg/kg). Intermittent bolus of inj. Fentanyl at 0.25 mcg/kg will
begiven as deemed necessary.
At the end of surgery, neuromuscular reversal agents (Neostigmine 50 microgram per kg body weight and Glycopyrrolate 10 micrograms per kg body weight). The
extubation time is measured as the time taken from last skin suture to the tracheal tube
removal and return of protective airway reflexes.
Vital parameters will be strictly monitored during the procedure. In the post-operative
period, the patient’s pain score will be checked and recorded as per NIPS scale at 5th minute
and later every 15 minutes for the first 1 hour, every 30 mins for next 2 hours and thenhourly till total of six hours after extubation. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
NEONATES UNDERGOING INFRAUMBILICAL SURGERIES |
|
| ExclusionCriteria |
| Details |
1. NEONATES WITH CONGENITAL ABNORMALITY
2.ALREADY INTUBATED NEONATE ON VENTILATORY SUPPORT
3.CONTRAINDICATIONS TO CAUDAL BLOCK |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMAPARE EXTUBATION TIME BY USING OPIOID AND NON-OPIOID TECHNIQUE FOR ANAESTHESIA IN NEONATES UNDERGOING INFRAUMBILICAL SURGERIES |
OUTCOME (EXTUBATION TIME) WOULD BE ASSESSED WHEN LAST SKIN SUTURE OF THE ONGOING SURGERY IS PLACED TO THE RETURN OF PROTECTIVE AIRWAY REFLEXES (GAG REFLEX) AND SPONTANEOUS BREATHING |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS AND COMPARE THE POST OPERATIVE PAIN SCORES BETWEEN OPIOID AND NON-OPIOID ANESTHESIA TECHNIQUE |
Pain will be assessed using Neonatal Infant Pain Scale (NIPS) at 5th minute and later every 15 minutes for the first 1 hour, every 30 mins for next 2 hours and then hourly till total of six hours after extubation. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/09/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neonates, being a high-risk population often need post-operative mechanical ventilation, which leads to higher mortality and stress on resources in developing countries like India with limited neonatal intensive care unit and ventilator facilities, inadequate resources and a lack of trained medical personnel. This prompts us to explore methods to minimize the intraoperative anaesthetic exposure and opioid techniques to aid early extubation which accelerate recovery, shorten length of hospital stay and decrease the medical expense.
There is a paucity of literature regarding this study between opioid versus non opioid anaesthesia techniques when used in conjunction with general anaesthesia in terms of time required to extubate the neonate and measurement of pain in the post operative period. Hence, we are conducting an observational study in which one group would be provided analgesia via caudal route and the other group via iv opioid and then the time required for extubation would be measured. |