| CTRI Number |
CTRI/2019/11/022101 [Registered on: 21/11/2019] Trial Registered Prospectively |
| Last Modified On: |
24/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Conscious sedation in pediatric patients for colonoscopy |
|
Scientific Title of Study
|
An observational study to assess sedative hemodynamic and analgesic effects of Dexmeditomidine and fentanyl in pediatric patients for colonoscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KOMULWAR VIJAYKUMAR GANGADHARRAO |
| Designation |
Junior Resident |
| Affiliation |
lokmanaya Tilak Muncipal Medical College And General Hospital |
| Address |
Department of Anaesthesiology Lokmanya Tilak Municipal Medical College And General Hospital 4th Floor College building Sion.Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7020639597 |
| Fax |
|
| Email |
vj26komul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shantanu Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Lokmanaya Tilak Muncipal Medical College And General Hospital |
| Address |
Lokmanya Tilak Municipal Medical College and General Hosptal Sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869100774 |
| Fax |
|
| Email |
drshan70@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shantanu Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Lokmanaya Tilak Muncipal Medical College And General Hospital |
| Address |
Lokmanya Tilak Municipal Medical College and General Hosptal Sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869100774 |
| Fax |
|
| Email |
drshan70@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal Medical College and General Hosptal Sion Mumbai |
|
|
Primary Sponsor
|
| Name |
DrVijaykumar gangadharrao komulwar |
| Address |
Dept.of anesthesia LTMMC hospital sion mumbai 400022 |
| 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 |
| Vijaykumar komulwar |
Lokmanaya Tilak Muncipal Medical College and General Hospital |
Department of Anesthesia LTMMC Hospital Sion Mumbai 400022
Mumbai
MAHARASHTRA |
7020639597
vj26komul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
all pts within above age group
pts for colonoscopy |
|
| ExclusionCriteria |
| Details |
inadequate nbm pts
not willing to participate pts |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To observe hemodynamic changes (Systolic blood pressure SBP, Diastolic blood pressure DBP Heart rate HR) in patients with Dexmedetomidine or Fentanyl.
2.To assess analgesic effects of Dexmedetomidine or Fentanyl using VAS score
3.To assess and maintain sedation to Ramsay sedation score(RSS) 5 during colonoscopy procedure
4.To assess duration of recovery to modified Aldrete score (MAS) 9 from sedation
|
Baseline vitals 2.premedication with glycopyrolate and dexmeditomidine to one gr.
3 premedication with glyco and fentanyl
4 induction with propofol and note down vitals at 5min till 60 min
5 note down procedure start and end time
6 count no of propofol in mg
7 assess recovery time. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess colonoscopy satisfaction after procedure on 3 rating scale poor/good/excellent
2.To study complications like apnea, hypotension, hypertension bradycardia, tachycardia, desaturation if any throughout procedure
|
1.To observe hemodynamic changes (Systolic blood pressure SBP, Diastolic blood pressure DBP Heart rate HR) in patients with Dexmedetomidine or Fentanyl.
2.To assess analgesic effects of Dexmedetomidine or Fentanyl using VAS score
3.To assess and maintain sedation to Ramsay sedation score(RSS) 5 during colonoscopy procedure
4.To assess duration of recovery to modified Aldrete score (MAS) 9 from sedation
|
|
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Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/11/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
After Institutional Ethics Committee approval, this prospective study will be conducted on 64 paediatric patients aged between 5 to 14 years posted for elective colonoscopy. 1. Preoperative evaluation of these patients will be done by the concerned anaesthesiologist. 2. Those patients satisfying inclusion criteria between ASA I and II and age group 5 to 14 years will be invited for the study. A written valid informed assent or consent will be taken. 3. Patients will be NBM for 8 hours before procedure All patients will have IV line in situ for the procedure. Patients will be taken on OT table and cardioscope, pulse oximeter, NIBP will be attached. Baseline parameters will be noted down. 4. Out of 64 patients 32 patients will receive dexmedetomidine will be grouped as (D) and 32 patients will receive fentanyl as group (F). Patients will be given premedication with inj. Glycopyrrolate 0.004 mg/kg IV & inj. Fentanyl 2 mcg/kg IV.to Group (F) and inj. Glycopyrrolate 0.004 mg/kg IV & inj. Dexmedetomidine 1 mcg/kg over 10 min to Group (D). Supplemental oxygen will be given at the rate of 2 lit/min via nasal prongs throughout the procedure. Then patients will be observed for Heart Rate, systolic BP (SBP), diastolic BP (DBP), SpO2 at baseline, after induction with inj.propofol and every 5 mins thereafter. During the procedure Ramsay Sedation Score (Table1) will be kept at level 5. Additional top up dose of Propofol 0.5mg/kg to keep Ramsay Sedation Score 5, will be noted. 5. Complications such as fall in SBP >15% of baseline, SpO2 < 90%, bradycardia, tachycardia, apnea, fall in RR, Hypertension will be observed during procedure and during recovery. Modified Aldrete score (Table 2) of 9 is considered adequate recovery from sedation. The duration from end of procedure to Modified C:UsersDr. VijaykumarDesktopLiterature Template new vijay.doc [Page : 7] Aldrete Score 9 is the recovery time. 6. At the end of procedure gastroenterologist will be asked to rate the sedation-analgesia on 3 point scale. (poor, good, excellent) 7. And analgesic efficacy assessed by using VAS scale. in recovery room. |