| CTRI Number |
CTRI/2018/10/016204 [Registered on: 30/10/2018] Trial Registered Prospectively |
| Last Modified On: |
29/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different techniques for loss of conciousness in children undergoing eye surgeries |
|
Scientific Title of Study
|
Comparison of two anaesthetic techniques in children undergoing vitreo-retinal surgery: inhalational vs TCI (Target controlled infusion) – A Randomised pilot clinical trial |
| Trial Acronym |
|
|
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 |
Dr Nishant Patel |
| Designation |
Assistant professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 5011
5th Floor Teaching Block
Department Of anaesthesiology,Pain medicine and critical care
AIIMS,New Delhi
Ansari Nagar
South
DELHI
110029
India |
| Phone |
8510955882 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Patel |
| Designation |
Assistant professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 5011
5th Floor Teaching Block
Department Of anaesthesiology,Pain medicine and critical care
AIIMS,New Delhi
Ansari Nagar
Flat no. 35 D, 3rd Floor
Vijay Mandal Enclave
Kalu sarai
Hauz Khas
New Delhi Pin 110016
DELHI
110029
India |
| Phone |
8510955882 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishant Patel |
| Designation |
Assistant professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 5011
5th Floor Teaching Block
Department Of anaesthesiology,Pain medicine and critical care
AIIMS,New Delhi
Ansari Nagar
Flat no. 35 D, 3rd Floor
Vijay Mandal Enclave
Kalu sarai
Hauz Khas
New Delhi Pin 110016
DELHI
110029
India |
| Phone |
8510955882 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Room No. 5011
5th Floor Teaching Block
Department of Anaesthesiology Pain medicine and critical care
AIIMS New Delhi |
| 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 Nishant Patel |
Dr Rajendra Prsad Center for ophthalmic sciences AIIMS New Delhi |
Room No 5011
Teaching block
Department Of Anaesthesiology Pain medicine and critical care
AIIMS New Delhi
South
DELHI |
8510955882
pateldrnishant@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H330||Retinal detachment with retinal break, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of two anaesthetic techniques in children undergoing vitreo-retinal surgery: inhalational vs TCI (Target controlled infusion) |
Children undergoing Vitreoretinal surgeries will receive either TCI (Target controlled infusion) or Inhalational based Anesthesia Technique |
| Comparator Agent |
Inhalational( Sevoflurane) Group |
Induced with sevoflurane 8% with fixed flow of 5L/min of 100% oxygen. After induction, iv cannula will be secured and fentanyl bolus of 2mcg/kg given. After which, appropriate size supraglottic device (SGD) will be inserted
Correct placement of SGD will be confirmed by appearance of ETCO2 waveform in all children.
In case of 3 attempts at SGD placement, child will be intubated with ETT and excluded from the study.
In both the groups atracurium bolus of 0.25mg/kg will be given after SGD is secured in place.
Time from starting of anaesthetic agents (sevoflurane) till the appearance of ETCO2 waveform after insertion of SGD will be noted.
Ease of insertion of LMA and number of attempts taken will also be recorded
Maintenance of Anaesthesia
oxygen, air and sevoflurane ( MAC 1.0-1.2)
Atracurium boluses will be administered
Intra-op analgesia provided with iv PCM and fentanyl boluses0.5 microgram/kg.
Intraoperative vitals will be monitored at 5 minutes interval.
Twenty minutes before end of surgery, iv 0.1mg/kg Ondensetron and 0.15 mg/kg of Dexamethasone will be administered.
At the end of surgery sevoflurane will be discontinued.
Effect of NMB agent will be reversed once spontaneous breathing efforts are present. SGD will be removed based of clinical parameters (along with MAC 0.3 and BIS 70)
After switching off of anesthetic agents (sevoflurane/propofol) three time periods will be noted:
removal of SGD
response to simple verbal command
acheivement of an Aldrette score of 9 or more
In the PACU, the follwing parameters will be noted at 10 min intervals Aldrette score, PAED( Paediatric anaesthesia emergence delirium scale) score, PNRS( Paediatric Numeric rating score), PONV incidence.
|
| Comparator Agent |
TCI ( Target Controlled Infusion )Propofol Group |
Iv Fentanyl bolus of 2mcg/kg will be given immediately followed by iv propofol infusion with TCI pump (Paedfusor model). Cp 4-6 mcg/L along with BIS titration (45-55). After which appropriate size SGD will be inserted.
Correct placement of SGD ( Supraglottic device)will be confirmed by appearance of ETCO2 waveform in all children.
In case of 3 attempts at SGD placement, child will be intubated with ETT and excluded from the study.
Atracurium bolus of 0.25mg/kg will be given after SGD is secured in place.
Time from starting of anaesthetic agents (sevoflurane/propofol) till the appearance of ETCO2 waveform after insertion of SGD will be noted.
Ease of insertion of LMA and number of attempts taken will also be recorded.
Maintenance of anaesthesia
oxygen, air and propofol infusion (TCI-), titrated to maintain Cp (target plasma concentration) of 3-6 mcg/L and BIS level of 45-55.
Atracurium boluses will be administered
Intra-op analgesia provided with iv PCM and fentanyl boluses0.5 microgram/kg.
Intraoperative vitals will be monitored at 5 minutes interval.
Twenty minutes before end of surgery, iv 0.1mg/kg Ondensetron and 0.15 mg/kg of Dexamethasone will be administered.
At the end of surgery Effect of NMB agent will be reversed once spontaneous breathing efforts are present.
SGD will be removed based of clinical parameters (along with MAC 0.3 and BIS 70)
After switching off of anesthetic agents (propofol) three time periods will be noted:
removal of SGD
response to simple verbal command
acheivement of an Aldrette score of 9 or more
In the PACU, the follwing parameters will be noted at 10 min intervals Aldrette score, PAED( Paediatric Anaesthesia Emergence Delirium Scale ), PNRS( Paediatric Numerical rating Score), PONV incidence.
|
|
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Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
ASA I/II
Elective vitreo-retinal surgeries
Duration of surgery >45 minutes and <3hrs
Written informed consent from parents
|
|
| ExclusionCriteria |
| Details |
children with Cardiac, hepatic and renal diseases
Congenital heart disease
Mental retardation
Syndromic children
Premedication with sedatives
Surgeries <45 minutes and >3hrs
Refusal to give consent
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparision of PACU stay and discharge time (from switching off of anaesthetic agents to achievement of Modified Aldrete score of 9 or more) of two anaesthetic techniques : TCI vs Inhalational in children undergoing vitreo-retinal surgery |
Post operative 0min,10min,20min,40min and 60 min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Induction Characteristics
Time of induction / loss of conciusness/verbal command
Smoothness of induction
Insertion of LMA ( Time taken/number of attempts)
Adverse events
INTRA-OP
Haemodynamics
Adverse events
POST-OP Variables
Emergence Profile
Time of awakening
Time to removal of LMA
Incidence of PONV
Adverse events
Cost effectiveness of both techniques
|
Intraoperative variables ( heart rate, Systolic,diastolic, mean blood pressure,oxygen saturation, end tidal carbon dioxide,minimum alveolar concentration of inhalational anaesthetic agent, bispectral index and Cp level of propofol) will be noted every 5 min
post op variables
o min, 10min,20 min,60 mi,1hr,2hr,4hr |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/11/2018 |
| 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
|
.Gillian R. Lauder,Total intravenous anesthesia will supercede inhalational anesthesia in pediatric anesthetic practice.Paediatr Anaesth. 2015 Jan;25(1):52-64.
2. J Gaynor, Paediatric total intravenous anaesthesiaBM FRCABJA Education, Volume 16, Issue 11, 1 November 2016, Pages 369–373
3. V. PICARD, Quality of recovery in children: sevoflurane versus propofol Acta Anaesthesiol Scand 2000; 44: 307–310).
4.Vora etal Sevoflurane versus propofol in the induction and maintenance of anaesthesia in children with laryngeal mask airway Kalpana S Vora1 Sri Lanka Journal of Child Health, 2014; 43(2): 77-83
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
For many decades, inhalational agents have been commonly used for the maintenance of anesthesia in pediatric population. However, with the introduction of newer intravenous induction agents and short acting opioids have revolutionized the day care anesthesia practice and subsequently TIVA (total intravenous anesthesia) has gained popularity in this patient population. (1,2,10) Vitreoretinal surgeries are performed in children with retinal abnormalities and generally last for a long duration of time. Using inhalational anesthesia with Sevoflurane for such a prolonged duration has been associated with emergence agitation. (3,4) Manual verses TCI infusion of propofol for maintenance of anesthesia has been found comparable in children but the use of TCI is considered safe and easily titrable with BIS monitoring. (5,8) The use of TIVA with propofol infusion for maintenance of anesthesia in adults has shown to have a clear headed recovery.(13) Earlier dedicated pediatric TCI infusion model were not in common practice .Now introduction of PK based TCI models like Pedfussor and Kataria available for children.(7,11,12) In our knowledge No study has been done so far to compare sevoflurane and TCI propofol infusion for maintainance of anesthesia in pediatric ophthalmic surgeries. We hypothesize that aneathesia administered using TCI propofol infusion in children, recovery will be clear headed and early discharge from PACU as compared to standard inhalational technique using Sevoflurane |