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Dexmedetomidine sedation in awake caudal block for lower abdominal surgeries in neonates

Dexmedetomidine sedation in awake caudal block for lower abdominal surgeries in neonates

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190114042358N3
Enrollment
100
Registered
2020-04-23
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

caudal block(Local anaesthetics). Anaesthetics and therapeutic gases

Interventions

Intervention 1: Intervention group: neonates first intervention group with ASA class I and II after proper monitoring including ECG and SPO2 NIBP in D group neonates Receive Dexmedetomidine 1ml/kg aft

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Infant Weighing less than 4 Kg Surgery of the lower abdomen ASA Class 1 and2

Exclusion criteria

Exclusion criteria: Patients with congenital neurological disease and seizures Caudal injection site infection Sepsis Sensitivity to topical anesthetics Bradycardia(HR<120) Any kind of heart block Congenital cyanotic heart diseases

Design outcomes

Primary

MeasureTime frame
Blood pressure. Timepoint: After entering the operating room?After doing caudal block every 1 minute to 5 minutes and every 5 minutes till release from recovery. Method of measurement: Monitor.;Heart rate. Timepoint: After entering the operating room?After doing caudal block every 1 minute to 5 minutes and every 5 minutes till release from recovery. Method of measurement: ECG device.;SPO2. Timepoint: After entering the operating room?After doing caudal block every 1 minute to 5 minutes and every 5 minutes till release from recovery. Method of measurement: pulse oximeter device.;Duration of the block. Timepoint: after proper monitoring in D group of neonates recieve 1ml/kg Dexmedetomidine and in N group of neonates recieve normal saline(1ml/kg) after administrating the druge the time required to perform the caudal block is recorded. Method of measurement: by an experienced anesthesiologist.;The number of attempts for block. Timepoint: after proper monitoring in D group of neonates recieve 1ml/kg Dexmedetomidine and in N group of neonates recieve1ml/kg normal saline after administrating the druge the number of times you try to perform caudal block is recorded. Method of measurement: by an experienced anesthesiologist.;Duration of stay in recovery. Timepoint: After entering till release from recovery. Method of measurement: According to Alderet Score.;Apnea. Timepoint: After entering till release from recovery. Method of measurement: monitor and face and color scale.;Sedation. Timepoint: 15 minutes after the block? and then every 5 minutes till release from recovery. Method of measurement: Sedation score table.

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