| CTRI Number |
CTRI/2018/05/013850 [Registered on: 11/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Randomized clinical study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Drugs like Dexmedetomidine and Fentanyl on emergence agitation and recovery after inhalational agent-sevoflurane anesthesia in children |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine versus fentanyl on emergence agitation and recovery profiles after Sevoflurane anesthesia in Pediatric patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta G Patel |
| Designation |
Associate professor(Anesthesiology) |
| Affiliation |
M.D. Anesthesia (Dept. of Anesthesiology, Medical College, Baroda) |
| Address |
Dept. of Anesthesiology, medical College and S.S.G.Hospital, Vadodara
Dept. of Anesthesiology, medical College and S.S.G.Hospital, Vadodara.
Vadodara
GUJARAT
390001
India |
| Phone |
9825453024 |
| Fax |
--- |
| Email |
mgpatel111@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta G Patel |
| Designation |
Associate professor(Anesthesiology) |
| Affiliation |
M.D. (Dept. of Anesthesiology, Medical College, Baroda) |
| Address |
Dept. of Anesthesiology, Medical College and S.S.G.Hospital,
Ananpura, Vadodara
Gujarat
Dept. of Anesthesiology, medical College and S.S.G.Hospital, Vadodara.
Vadodara
GUJARAT
390001
India |
| Phone |
9825453024 |
| Fax |
--- |
| Email |
mgpatel111@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Bawdekar |
| Designation |
EX-Resident |
| Affiliation |
Dept. of Anesthesiology, Medical college, Baroda |
| Address |
Dept. of Anesthesiology,
Medical college, Baroda
Anandpura, Vadodara
Dept. of Anesthesiology,
Medical college, Baroda and S.S.G.Hospital, Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9448866819 |
| Fax |
|
| Email |
rashbawdekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government hospital
S.S.G.Hospital, Anandpura, vadodara. |
|
|
Primary Sponsor
|
| Name |
Dept of Anesthesiology Medical college Baroda |
| Address |
Dept. of Anesthesiology,
Medical college, Baroda and S.S.G.Hospital, Anandpura, Vadodara |
| Type of Sponsor |
Government medical college |
|
|
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 Mamta G Patel |
Medical college & S.S.G.Hospital, Baroda |
Dept. of Anesthesiology,
Medical college, Baroda and S.S.G.Hospital, vadodara
Vadodara
GUJARAT |
9825453024
mgpatel111@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific and Ethical research committee, MCB 7SSGH, Baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy ASA PS I &II pediatric patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
Dexmedetomidine, a newer agent was compared to Fentanyl, a control, for reduction of emergence agitatation after Sevoflurane anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
• 60 children of ASA I/II
• Type of surgery-
 Orchidopexy
 Circumcision
 Hypospadiasis repair
 Congenital hernia/ hydrocele repair
|
|
| ExclusionCriteria |
| Details |
• Children <3yrs and >10 yrs
• Patients with URTI, asthma
• Anticipated difficult intubation
• Cardio respiratory, hepatic, renal dysfunction
• H/O of allergy to the drugs used
• H/O any sedative drugs used
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the effect of IV Dexmedetomidine and IV Fentanyl in attenuation of emergence agitation after Sevoflurane anaesthesia in children using Five Point Emergence Agitation Scale. |
To observe the effect of IV Dexmedetomidine and IV Fentanyl in attenuation of emergence agitation after Sevoflurane anaesthesia in children using Five Point Emergence Agitation Scale at every 15 minutes upto 120 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To observe the recovery profile using Modified Aldrete Recovery Score.
2. To observe haemodynamic and respiratory parameters perioperatively.
3. To observe post operative complications and side effects.
|
1,5,10,20,30,60,120 MIN |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/06/2013 |
| Date of Study Completion (India) |
27/12/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In our study we found it appropriate to compare the effect of a short acting opioid Fentanyl with the new selective α2-adrenergic receptor agonist Dexmedetomidine given immediately after intubation, to reduce emergence agitation and also observe the recovery characteristics in children aged 3-10 years after Sevoflurane anaesthesia |