Comparison of dexmedetomidine and midazolam in hemodynamic response control during tracheal intubation

Comparison of dexmedetomidine and midazolam to control hemodynamic responses during laryngoscopy and intubation in upper extremity elective surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017040833291N1

Enrollment

Registered

2017-05-04

Start date

2017-06-22

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

Tracheal intubation. Other medical procedures

Interventions

Prevention

Intervention 1: Intervention group: before induction, 2 µg/kg fentanyl and 0.6 mg/kg dexmedetomidine will be injected as a prodrug. Intervention 2: Control group: before induction, 2 µg/kg fentanyl an

Intervention group: before induction, 2 µg/kg fentanyl and 0.6 mg/kg dexmedetomidine will be injected as a prodrug.

Control group: before induction, 2 µg/kg fentanyl and 0.05 mg/kg midazolam will be injected as a prodrug.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients at the age of 18 to 60 years old; class 1 and 2 of America Society of Anesthesiology (ASA); candidate for upper extremity elective surgery; willingness to participate in the study. Exclusion criteria: Difficult intubation; extreme obesity; Cardiac and pulmonary diseases; hypertension; Chronic Diseases; Allergic Diseases; opium addiction; pregnancy; body temperature over 38 degrees Celsius; history of using alpha-2 receptor antagonists; drugs using for high blood pressure (hypertension); Beta blockers; Acute Angle Closure Glaucoma; Lower respiratory tract problems and asthma; hypersensitivity to antihistamine.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Systolic blood pressure. Timepoint: at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room. Method of measurement: Monitoring devise.;Diastolic blood pressure. Timepoint: at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room. Method of measurement: Monitoring devise.;Mean arterial blood pressure. Timepoint: at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room. Method of measurement: Monitoring devise.;Heart rate. Timepoint: at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room. Method of measurement: Pulse Oxymetery.;Arterial oxygen saturation. Timepoint: at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room. Method of measurement: Monitoring devise.	—

Measure

Time frame

Systolic blood pressure. Timepoint: at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room. Method of measurement: Monitoring devise.;Diastolic blood pressure. Timepoint: at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room. Method of measurement: Monitoring devise.;Mean arterial blood pressure. Timepoint: at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room. Method of measurement: Monitoring devise.;Heart rate. Timepoint: at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room. Method of measurement: Pulse Oxymetery.;Arterial oxygen saturation. Timepoint: at baseline, before of induction, 1, 5, 10, 20, 30, 60 and 90 minutes after intubation, at the end of the surgery and in the recovery room. Method of measurement: Monitoring devise.

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Secondary

Measure	Time frame
Shivering. Timepoint: Every 10 min until 30 min after entering the recovery room. Method of measurement: Clinical observation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Bijan Heyrat

Qazvin University of Medical Sciences

dr.bijan.heyrat@gmail.com+98 28 3332 0105

Outcome results

None listed

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