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Comparison of two sedative drugs (Propofol and Fentanyl)in view of efficacy and safety to alleviate pain and discomfort in children who under going camera test of wind pipe(Bronchoscopy)

Comparison of Intravenous Propofol and Fentanyl for Conscious Sedation for Paediatric Bronchoscopy A Randomised Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/09/007307
Enrollment
50
Registered
2016-09-26
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: null- No volunteer will be entertained Those who are having clear indication for bronchoscopy and that has been selected by the treating team.

Interventions

Intervention1: Arm 02-IV Propofol 1mg/kg slow bolus over 1minute followed by 2mg/kg/hour infusion maximum of 15 minutes or end of the procedure whichever comes first.: 1% propofol 10mg/ml will be used

Sponsors

Investigator initiatiated study no external support
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the children who will be selected for Bronchoscopy at division of pulmonology, department of Paediatrics, AIIMS with age between 3-15 years.

Exclusion criteria

Exclusion criteria: 1.Previous untoward reaction for medications are used for sedation 2.Children with history of lipid allergy 3.Cardiovascular instability (Needing Inotropic Support) 4.O2 dependency at the time of enrolment 5.SPO2 6.Encephalopathy or Low conscious level 7.Evidence of acute or chronic liver disease 8.Children who are already on any sedative medication including antiepileptic drugs 9.Contraindications to use medications 10.Not consented

Design outcomes

Primary

MeasureTime frame
Time to achieve Ramsay score 03 Time in seconds from completion of administration of medication to achieve score 03 Timepoint: Time in seconds from completion of administration of medication to achieve score 03Directly measured by stop watch(Stop watch will be started at the end of injection and time in seconds will be recorded once Ramsay score 3 is achieved)

Secondary

MeasureTime frame
Cough ScoreTimepoint: 100 mm Visual Analogue Scale will be done by watching video recorder;Dropping of Pulse Rate 10% from base line(At least single episode) during or after procedureTimepoint: Document Heart Rate before giving sedation and continuous monitoring of Pulse Rate up to 1 hour after procedure;Level of Airway SecretionTimepoint: 100mm Visual analogue scale will be done by watching video recorder;Need for IV MidazolamTimepoint: Number of IV Midazolam 0.1mg/kg doses(0/1/2);Observation of any episode of Apnoea10 seconds within 10 minutes of administration of sedationTimepoint: Document respiratory rate before procedure and monitor respiratory rate up to 1 hour after procedure and observe patient for 10 min for any episode of apnoea after giving sedation;Observation of maximum drop of Pulse rate after administration of sedationTimepoint: Monitoring of pulse rate and documentation of base line, the lowest value and drop.;Observation of maximum drop of SaO2 after administration of sedationTimepoint: Monitoring of SaO2 from monitor and documentation of base line SaO2 value the lowest value and drop;Observation of maximum rise of pulse rate after administration of sedationTimepoint: Monitoring of pulse rate and documentation of base line, the highest value and rise.;Observation of SaO2 drop 10% from Baseline during the procedure or after procedure(At least single episode) Timepoint: Document SaO2 before giving sedation and continuous monitoring of SaO2 during and up to 1 hour after procedure with pulse oximetry appropriate probe. Number of episodes of SPO2 drops with good wave forms in monitor will be documented.;Physician SatisfactionTimepoint: Performers satisfaction will be recorded by his feeling by using a 100mm visual analogue score;Time to achieve recovery score of 06 in secondsTimepoint: Stop watch will be started at the completion of administration of sedation and stopped once recovery score of 06 Achieved

Countries

India

Contacts

Public ContactSUSHIL KUMAR KABRA

All India Institute of Medical Sciences -Delhi

skkabra@hotmail.com9891479796

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026