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Comparison of Dexmedetomidine and Fentanyl for awake intubation in neonates

Comparison of Dexmedetomidine and Fentanyl for awake intubation in neonates

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190114042358N2
Enrollment
70
Registered
2020-04-20
Start date
2019-04-21
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

intubation. Failed or difficult intubation

Interventions

Intervention 1: Intervention groups :neonate ASA class 1 to 3 received Fentanyl(2µg/kg)in group F.The patient vital signs are recorded every minute after prescribing premedication then laryngoscopy wi

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

Inclusion criteria: neonate with ASA status1 to3 indicative elective surgery surgery requires awake intubation neonate in need of intubation are likely to have difficulty intubation term neonate weighing less than 4 kg preterm neonate there is no restriction on the minimum gestational age in neonate entering the study

Exclusion criteria

Exclusion criteria: emergency surgerys bradicardia (HR<120) any kind of heart block congenital anomalies in the airways such as cleft palate possibility of increasing ICP neonatal with ventriculoperitoneal shunt sensitivity to any of the drugs used in the study

Design outcomes

Primary

MeasureTime frame
The time it takes to intubation. Timepoint: after premedication in group F with 2µg/kg Fentanyl and in D group with 1µg/kg Dexmedetomidine laryngoscopy with a suitable miller blade and the patient with the appropriate size chip tube is selected by an experienced anesthesiologist and the required time of sussessful for intubation in each group is recorded. Method of measurement: by an experienced anesthesiologist.;The number of attemptes for intubation. Timepoint: after premedication in group F with 2µg/kg Fentanyl and in D group with 1µg/kg Dexmedetomidine laryngoscopy with a suitable miller blade and the patient with the appropriate size chip tube is selected by an experienced anesthesiologist and the number of sussessful attemptes for sussessful intubation in each group is recorded. Method of measurement: by an experienced anesthesiologist.;Apnea. Timepoint: After entering the operating room to the time of the intubation. Method of measurement: monitor and face and color scale.;Sedation. Timepoint: 3 minutes after receiving premedication. Method of measurement: Sedation score table.;Blood pressure. Timepoint: After entering the operating room? blood pressure is recorded every minute after prescribing premedication and then immediately after intubation and then every minute t0 5 minutes. Method of measurement: Monitor.;Heart rate. Timepoint: After entering the operating room? heart rate is recorded every minute after prescribing premedication and then immediately after intubation and then every minute t0 5 minutes. Method of measurement: ECG device.;SPO2. Timepoint: After entering the operating room? SPO2 is recorded every minute after prescribing premedication and then immediately after intubation and then every minute t0 5 minutes. Method of measurement: Pulse oximeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDaryoush Sheikhzadeh

Tabriz University of Medical Sciences

dr.d.sheik@gmail.com+98 41 3526 2255

Outcome results

None listed

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