CTRI Number |
CTRI/2018/03/012807 [Registered on: 23/03/2018] Trial Registered Retrospectively |
Last Modified On: |
31/08/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Comparative Study |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of Dexmedetomidine and Midazolam as Intanasal Premedication in Children |
Scientific Title of Study
|
A Comparative Study of Intranasal Dexmedetomidine and Intranasal Midazolam as Premedication in Children Undergoing Short Surgical Procedures |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rahul Fernandez |
Designation |
Post Graduate Resident |
Affiliation |
Department of Anaesthesiology |
Address |
Department of Anaesthesiology and Critical Care, St. Johns Medical College Hospital, Sarjapur Road, Bangalore. St. Johns Medical College Hospital, Sarjapur Road, Bangalore. Bangalore KARNATAKA 560034 India |
Phone |
08025631714 |
Fax |
|
Email |
rahul.rainmaker@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Moses Charles DSouza |
Designation |
Professor |
Affiliation |
Department of Anaesthesiology and Critical Care |
Address |
Department of Anaesthesiology and Critical Care, St. Johns Medical College Hospital, Sarjapur Road, Bangalore. St. Johns Medical College Hospital, Sarjapur Road, Bangalore. Bangalore KARNATAKA 560034 India |
Phone |
08025631714 |
Fax |
|
Email |
drmosescharlesdsouza@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Moses Charles DSouza |
Designation |
Professor |
Affiliation |
Department of Anaesthesiology and Critical Care |
Address |
Department of Anaesthesiology and Critical Care, St. Johns Medical College Hospital, Sarjapur Road, Bangalore. St. Johns Medical College Hospital, Sarjapur Road, Bangalore. Bangalore KARNATAKA 560034 India |
Phone |
08025631714 |
Fax |
|
Email |
drmosescharlesdsouza@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Principle Investigator |
Address |
St. Johns Medical College Hospital, Sarjapur Road, Bangalore. |
Type of Sponsor |
Other [Self] |
|
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 Rahul Fernandez |
St. Johns Medical College Hospital |
Pediatric Surgery Operating Theater Complex Bangalore KARNATAKA |
08025631714
rahul.rainmaker@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
Children aged 2-10 years undergoing minor surgical procedures under general anaesthesia, (1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
10.00 Year(s) |
Gender |
Both |
Details |
Children aged 2-10 years undergoing minor surgical procedures under general anaesthesia
American Society of Anaestheiologists (ASA) Physical Status I & II grade of patients.
|
|
ExclusionCriteria |
Details |
Parent refusal
Known allergy to the drugs under study.
Cardiac dysrhythmias and/or congenital heart disease
Psychotropic medication use
Mental retardation
Nasal disorders interfering with administration of medication as recurrent nasal bleeding or nasal masses.
Children who spat or refused intranasal administration of medication.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S).
Parental Separation Anxiety scale (PSAS).
Mask Acceptance Score(MAS). |
Modified observer’s Assessment of Alertness/Sedation scale (MOAA/S). 30 minutes.
Parental Separation Anxiety scale (PSAS). 30 minutes.
Mask Acceptance Score(MAS). 30 minutes. |
|
Secondary Outcome
|
Outcome |
TimePoints |
pulse rate, BP, respiratory rate and oxygen saturation were recorded every 10 minute interval for 30 minutes from the time of extubation |
pulse rate, BP, respiratory rate and oxygen saturation were recorded every 10 minute interval for 30 minutes from the time of extubation |
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="104" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
01/01/2016 |
Date of Study Completion (India) |
01/12/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Global Journal for Research Analysis.
Volume-7, Issue-12, December-2018. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
SUMMARY
This study was conducted in the
department of anesthesiology and critical care at the pediatric surgery
operating theatre complex, St. John’s Medical College Hospital, Bangalore.
In this study, 104 ASA grade I and
II children between 2-10 years, who were scheduled for elective surgical
procedures were observed. The patients that received intranasal Dexmedatomidine
(1µg/kg) were allotted to group D and the patients that received intranasal
Midazolam (0.2mg/kg) were put under group M.
30 minutes after premedication with
the intranasal drug, the Parental Separation Anxiety Score was assessed on a 4
point scale and sedation of the child was assessed using a 6 point Modified
Observer’s Assessment of Alertness/Sedation Scale. Prior to anesthesia
induction the Mask Acceptance Score was assessed using a 5 point scale.
There was a marked variation between
the two groups with regards to the parental separation. There was a
statistically significant data which concluded the children premedicated with
intranasal Dexmedetomidine separated much more easily than those premedicated
with intranasal Midazolam.
The Modified Observer’s Assessment
of Alertness/Sedation scores showed a significantly better score in the
Dexmedetomidine group compared to Midazolam, indicating a better degree of
sedation among those premedicated with Dexmedetomidine.
There was a statistically
significant difference with respect to mask acceptance before induction of
anesthesia. The patients premedicated with intranasal Dexmedetomidine had better
mask acceptance compared to those premedicated with intranasal Midazolam.
The demographic data recorded found
no difference in the age or gender between the two groups.
After premedication the children
were monitored for 30 minutes at every 10 minute interval, prior to induction
of anesthesia. Vital signs (heart rate, BP, respiratory rate and oxygen
saturation) were recorded. After administering intranasal premedication it was
found the there was a fall in heart rate, without significant fall in blood
pressure in the patients who were administered Dexmedetomidine. There was no
change in the respiratory rate or oxygen saturation.
Intra-operatively, the vitals were
monitored every 5 minute interval for 30 minutes and thereafter every 10
minutes till the end of the procedure. The intra-operative period showed no
significant variation in the vital parameters between the two groups.
Post
operatively the children were monitored for 24 hours after the procedure. The
vitals were stable and there were no adverse reactions in any of the children.
Therefore, based on these results
it can be concluded that intranasal Dexmedetomidine (1 µg/kg) is more
efficacious than intranasal Midazolam (0.2 mg/kg) for premedicating
children undergoing short elective surgical procedures.
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