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Tracheal intubation without muscle relaxant

Tracheal intubation without muscle relaxant with Propofol or Sevoflurane in 2-7 year old children undergoing ear-nose-throat surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201102135822N1
Enrollment
75
Registered
2011-03-14
Start date
2010-01-11
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

general anesthesia for ear-nose-throat surgery. Chronic serous otitis media

Interventions

Intervention 1: intervention group: lidocaine 1.5 mg/kg, remifentanil 2 µg/kg and propofol 2mg/kg were injected intravenously. Intervention 2: lidocaine 1.5 mg/kg intravenously and remifentanil 2 µg/
Treatment - Drugs
intervention group: lidocaine 1.5 mg/kg, remifentanil 2 µg/kg and propofol 2mg/kg were injected intravenously
lidocaine 1.5 mg/kg intravenously and remifentanil 2 µg/kg intravenously injected and sevoflurane 3%MAC inhalationaly was added

Sponsors

Vice chancellor for research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria): 1)age 2-7 years, 2)ENT & Eye surgery candidate. Exclusion Criteria): 1) cardiac disease, 2)asthma and any other pulmonary disease, 3)gastroesophagial reflux, 4)morbid obesity (BMI>30) , 5)difficult tracheal expected intubation.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The ease with which the patient is intubated. Timepoint: at the time of intubation (start of anesthesia). Method of measurement: an scoring system measuring the ease/difficulty of intubation (scored by the anesthesiologist).

Secondary

MeasureTime frame
The ease of mask ventilation. Timepoint: after induction of general anesthesia. Method of measurement: an scoring system measuring the ease/difficulty of mask ventilation.;Vocal cord position. Timepoint: at the time of tracheal intubation. Method of measurement: an scoring system measuring the vocal cord position by anesthesiologist.;The ease of laryngoscopy. Timepoint: at the time of laryngoscopy. Method of measurement: an scoring system measuring the ease/difficulty of laryngoscopy by anesthesiologist.;Coughing. Timepoint: at the time of tracheal intubation. Method of measurement: an scoring system measuring the coughing by anesthesiologist.;Blood pressure changes. Timepoint: before and at the time of intubation,5 min after intubation. Method of measurement: non invasive blood pressure monitoring.;Heart rate changes. Timepoint: before and at the time of intubation,5 min after intubation. Method of measurement: ECG monitoring.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Nazanin Mirabi

Tehran university of medical sciences

nazaninmirabi@yahoo.com+98 21 6651 6001

Outcome results

None listed

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