| CTRI Number |
CTRI/2021/04/033258 [Registered on: 30/04/2021] Trial Registered Prospectively |
| Last Modified On: |
29/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Intranasal dexmedetomidine and ketamine combination used for procedural sedation in pediatric patients undergoing minor surgeries : comparison of different dosage combinations |
|
Scientific Title of Study
|
Comparison of different dosage combinations of intranasal dexmedetomidine and ketamine used for procedural sedation in pediatric patients undergoing minor surgeries in day care setup |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suchismita Pal |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anesthesiology, Diamond Harbour government Medical College and Hospital |
| Address |
Department of Anesthesiology, Diamond Harbour Government Medical College And Hospital,
Diamond Harbour Rd, Harindanga, Diamond Harbour
South Twentyfour Parganas
WEST BENGAL
743331
India |
| Phone |
9474599093 |
| Fax |
|
| Email |
suchiofficial21@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suchismita Pal |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anesthesiology, Diamond Harbour government Medical College and Hospital |
| Address |
Department of Anesthesiology, Diamond Harbour Government Medical College And Hospital,
Diamond Harbour Rd, Harindanga,Diamond Harbour
South Twentyfour Parganas
WEST BENGAL
743331
India |
| Phone |
9474599093 |
| Fax |
|
| Email |
suchiofficial21@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Suchismita Pal |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anesthesiology, Diamond Harbour government Medical College and Hospital |
| Address |
Department of Anesthesiology, Diamond Harbour Government Medical College And Hospital,
Diamond Harbour,
South Twentyfour Parganas
WEST BENGAL
743331
India |
| Phone |
9474599093 |
| Fax |
|
| Email |
suchiofficial21@gamil.com |
|
|
Source of Monetary or Material Support
|
| Department of Anestesiology,
Diamond Harbour Government Medical college and Hospital,Diamond Harbour Road, Haridanga, Diamond Harbour,South24 Parganas,West Bengal,Pin - 743331
|
|
|
Primary Sponsor
|
| Name |
Diamond harbour Government Medical College and hospital |
| Address |
Diamond Harbour Government Medical College and Hospital, Diamond Harbour |
| 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 |
| Suchismita Pal |
Department of Anesthesiology , 4th floor, Super speciality Building (SSH)l |
Diamond Harbour Government Medical College and Hospital
South Twentyfour Parganas
WEST BENGAL |
9474599093
suchiofficial21@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics Committee, Diamond harbour Government Medical college and hospital |
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 |
| Intervention |
Dexmedetomidine, ketamine |
Intranasal application of Dexmedetomidine and ketamine in 2 dosage combinations.
Grp 1- dexmedetomidine (1mcg/kg) and ketamine ( 5 mg/kg)
Grp 2- dexmedetomidine ( 1mcg/kg) and ketamine ( 7mg/kg) |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2,
minor surgical procedures less than 30 mins |
|
| ExclusionCriteria |
| Details |
cardiac arrthymia
mental retardation
known allergy to stydy drugs
upper respiratory tract infection
anatomic airway abnormalities
parental refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine the degree of sedation at the time of parental separation |
Determine the degree of sedation after 30 mins of administration of drug. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| acceptance of intravenous cannulation, hemodynamic changes, emergence agitation, duration of recovery of the patient |
1 hour |
|
|
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)
|
03/05/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Procedural sedation of pediatric patients are carried out for different diagnostic as well as minor surgical procedures. The uncooperative behaviour in pediatric patients during such procedures arise from anxiety due to separation from parents into the unfamiliar environment along with the fear of painful interventions which is serious concern for the attending anesthesiologists. The intranasal route of administration of the combined dosage of ketamine and dexmedetomidine will produce an ideal combination of sedation for pediatric patients. The primary objective of the study is to determine the degree of sedation at the time of separation from parents.
|