Alfentanil and Dexmedetomidine for awake fiberoptic intubation

Comparison the efficacy of alfentanil and Dexmedetomidine in control of agitation and hemodynamic instability for patients candidates for surgery during fiberoptic intubation

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20141202020185N2

Enrollment

Registered

2020-05-17

Start date

2020-04-19

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

None listed

Interventions

Intervention 1: Intervention group: Patients in the alfentanil group receive a loading dose 20µg/kg intravenously over 60-90 seconds and then 10 µg/kg repeat every 1 to 2 minutes over 10-20 seconds to

Eligibility

Sex/Gender

All

Age

30 Years to 55 Years

Inclusion criteria

Inclusion criteria: age between 30 and 55 years old and candidates for elective urologic surgery

Exclusion criteria

Exclusion criteria: pregnant women diabetes mellitus uremia or renal failure heart failure existence of any type of cardiac arrhythmia emergency surgery

Design outcomes

Primary

Measure	Time frame
Vocal cord position during fiberoptic intubation. Timepoint: We administer Alfentanil or Dexmedetomidine and once the patient reach to the level of 3 or more of Ramsay Sedation Scale the procedure starts and during passage from larynx , the vocal cord position will assess. Method of measurement: open/moving/closed.;Limb movement. Timepoint: During all the time of performance of procedure,it means from entrance of fiberoptic into the mouth till entrance of tracheal tube into the trachea. Method of measurement: none/mild/sever.;Cough. Timepoint: During all the time of performance of procedure,it means from entrance of fiberoptic into the mouth till insertion the tracheal tube into the trachea. Method of measurement: none/mild/moderate/sever.;Patient tolerance. Timepoint: During all the time of performance of procedure,it means from entrance of fiberoptic into the mouth till insertion the tracheal tube into the trachea. Method of measurement: no reaction/slight grimacing/heavy grimacing/verbal.;Postintubation cooperation. Timepoint: Immediately after insertion of tracheal tube. Method of measurement: cooperative/slight resistance/sever resistance leaded to general anesthesia.	—

Measure

Time frame

Vocal cord position during fiberoptic intubation. Timepoint: We administer Alfentanil or Dexmedetomidine and once the patient reach to the level of 3 or more of Ramsay Sedation Scale the procedure starts and during passage from larynx , the vocal cord position will assess. Method of measurement: open/moving/closed.;Limb movement. Timepoint: During all the time of performance of procedure,it means from entrance of fiberoptic into the mouth till entrance of tracheal tube into the trachea. Method of measurement: none/mild/sever.;Cough. Timepoint: During all the time of performance of procedure,it means from entrance of fiberoptic into the mouth till insertion the tracheal tube into the trachea. Method of measurement: none/mild/moderate/sever.;Patient tolerance. Timepoint: During all the time of performance of procedure,it means from entrance of fiberoptic into the mouth till insertion the tracheal tube into the trachea. Method of measurement: no reaction/slight grimacing/heavy grimacing/verbal.;Postintubation cooperation. Timepoint: Immediately after insertion of tracheal tube. Method of measurement: cooperative/slight resistance/sever resistance leaded to general anesthesia.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Solhpour

Shahid Beheshti University of Medical Sciences

solhpourali@sbmu.ac.ir+98 21 2254 3640

Outcome results