Conscious sedation in pediatric patients for colonoscopy

An observational study to assess sedative hemodynamic and analgesic effects of Dexmeditomidine and fentanyl in pediatric patients for colonoscopy

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/11/022101

Enrollment

Registered

2019-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K638- Other specified diseases of intestine

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: all pts within above age group pts for colonoscopy

Exclusion criteria

Exclusion criteria: inadequate nbm pts not willing to participate pts

Design outcomes

Primary

Measure	Time frame
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 Timepoint: 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.	—

Measure

Time frame

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 Timepoint: 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.

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Secondary

Measure	Time frame
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 Timepoint: 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	—

Measure

Time frame

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 Timepoint: 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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Countries

India

Contacts

Public ContactDr Shantanu Kulkarni

Lokmanaya Tilak Muncipal Medical College And General Hospital

drshan70@rediffmail.com9869100774

Outcome results