Conscious sedation in pediatric patients for colonoscopy

Phase 3

Not yet recruiting

• Conditions: Other specified diseases of intestine,

• Registration Number: CTRI/2019/11/022101
• Lead Sponsor: DrVijaykumar gangadharrao komulwar

Brief Summary

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

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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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-21
• Last Update Posted: 2019-11-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

all pts within above age group pts for colonoscopy.

Exclusion Criteria

inadequate nbm pts not willing to participate pts.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To observe hemodynamic changes (Systolic blood pressure SBP, Diastolic blood pressure DBP Heart rate HR) in patients with Dexmedetomidine or Fentanyl.	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.
2.To assess analgesic effects of Dexmedetomidine or Fentanyl using VAS score	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.
3.To assess and maintain sedation to Ramsay sedation score(RSS) 5 during colonoscopy procedure	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.
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lokmanaya Tilak Muncipal Medical College and General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Lokmanaya Tilak Muncipal Medical College and General Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Vijaykumar komulwar

Principal investigator

7020639597

vj26komul@gmail.com