| CTRI Number |
CTRI/2018/05/013772 [Registered on: 08/05/2018] Trial Registered Prospectively |
| Last Modified On: |
03/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using dexmeditomidine with midazolam and ketamine, as premedication in children of age group 3-10 years, and comapring their effects. |
|
Scientific Title of Study
|
A comparative evaluation of nebulized dexmedetomidine-ketamine versus nebulized dexmedetomidine-midazolam as premedication in pediatric patients undergoing surgery under general anesthesia:A prospective, randomized double blind study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanvi Dhiman |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. Rajendra Prasad Government Medical College, Kangra at Tanda |
| Address |
Department of Anesthesiology, Dr.R.P.G.M.C.
Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7696781240 |
| Fax |
|
| Email |
dr.tanvi90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Versha Verma |
| Designation |
Assistant Professor |
| Affiliation |
Dr. Rajendra Prasad Government Medical College, Kangra at Tanda |
| Address |
Department of Anesthesiology, Dr.R.P.G.M.C.
Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
versha2u@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Tanvi Dhiman |
| Designation |
Post Graduate |
| Affiliation |
Dr. Rajendra Prasad Government Medical College, Kangra at Tanda |
| Address |
Department of anesthesiology,
Dr.R.P.G.M.C,
Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7696781240 |
| Fax |
|
| Email |
dr.tanvi90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Dr.R.P.G.M.C.Kangra at Tanda
Kangra-176001 H.P. |
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Kangra atTanda |
| Address |
Department of Anesthesiology, Dr.R.P.G.M.C.
Kangra at Tanda - 176001 H.P. |
| 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 |
| Tanvi Dhiman |
Dr. Rajendra Prasad Government Medical College |
2nd floor, OT complex
Department of anesthesiology
Kangra
HIMACHAL PRADESH |
7696781240
dr.tanvi90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department of Anesthesiology, Dr.RPGMC Kangra at Tanda Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients of age group 3-10 years,undergoing elective surgery under general anesthesia, having ASA 1 & 2 , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine 1 mcg/kg in 3ml of saline 0.9% |
| Comparator Agent |
Ketamine |
Ketamine 0.5 mcg/kg with Dexmedetomidine 1 mcg/kg in 3ml of saline 0.9% |
| Comparator Agent |
Midazolam |
midazolam 0.5 mcg/kg with dexmedetomidine 1 mcg/kg in 3 ml of saline 0.9% |
| Intervention |
Nebulization |
Nebulization will be done in pediatric patients 30 minutes prior to surgical procedure. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Class I & II.
2.Weight between 8-40 kgs.
3.Undergoing elective surgical procedure. |
|
| ExclusionCriteria |
| Details |
1.Known allergy to the study drug.
2.Organ dysfunction.
3.Cardiac dysrrhythmia and/or Congenital heart disease.
4.Psychotropic medication use and mental retardation.
5.History of chronic illness,prematurity,or developmental delay.
6.Medical conditions contraindicating the use of drugs like-active GERD, uncontrolled vomiting, recent history of apnea,and active respiratory issues.
7.Nasal deformities-spur and deviated nasal septum.
8.Uncooperative patients.
9.Surgery for more than two hours.
10.Gut surgery |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare parenteral separation and mask acceptance with ketamine and midazolam when combined with dexmedetomididne repectively, in nebulized form. |
4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The level of sedation when child is first seen in the operating room.
2.Acceptance of IV cannulation.
3.Analgesia,sedation at emergence and wake up behaviour. |
4 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/05/2018 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Preoperative period is a stressful event in majority of pediatric individual undergoing surgical procedure. Smooth induction of anesthesia in pediatric patients requires adequate premedication.
Nebulization drug delivery is relatively easy and atraumatic mode. It reduces anxiety pain; decreases physical discomfort ; minimizes psychological trauma with a potential for anesthesia. Dexmedetomidine is potent drug and causes dose related sedation by its effect. It has been used in pediatric patients as premedication, as there is no respiratory depression or confusional state.
Midazolam and ketamine has also been used as premedication. Ketamine has been used to induce sedation and analgesia in various settings. Midazolam has rapid onset of action and good sedation.
All three drugs have their own side effects, respectively. The individual disadvantage of each drug can be counterbalanced when used in combination. The purpose of this study is to compare the efficacy of two nebulized sedation combination regimes of dexmedetomidine-ketamine and dexmedetomidine-midazolam in pediatric patients.
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