Evaluation of the effect of Midazolam and Dexmedetomidine in Laminectomy surgery under spinal anesthesia

Comparative study of hemodynamic changes, amount of bleeding, satisfaction of surgeon and patient in the use of two drugs, Midazolam and Dexmedetomedin, in laminectomy surgery under spinal anesthesia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160307026950N22

Enrollment

105

Registered

2020-07-21

Start date

2020-07-22

Completion date

Unknown

Last updated

2020-08-17

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

Conditions

Laminctomy surgery. Other disorders of nervous system in diseases classified elsewhere

Interventions

Intervention 1: Intervention Group A: Patients receive 0.2 mg of Midazolam per kilogram of body weight per hour after spinal anesthesia. Intervention 2: Intervention Group B: Patients receive 0.1 micr

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients are candidates for laminectomy surgery under spinal anesthesia Age range 18 to 65 years old ASA class I and II anesthesia The patient's consent to participate in the study

Exclusion criteria

Exclusion criteria: Unstable hemodynamic at the beginning of the operation (systolic pressure less than 90, diastolic less than 60 and heart rate less than 60) Taking medications that affect the hemodynamic status Taking anticoagulants

Design outcomes

Primary

Measure	Time frame
Systolic Blood Pressure. Timepoint: Before surgery, after spinal anesthesia, 20 minutes after the Intervention injection and then every 30 minutes until the end of recovery. Method of measurement: Non-invasive blood pressure measurement.;Diastolic Blood Pressure. Timepoint: Before surgery, after spinal anesthesia, 20 minutes after the Intervention injection and then every 30 minutes until the end of recovery. Method of measurement: Non-invasive blood pressure measurement.;Heart Rate. Timepoint: Before surgery, after spinal anesthesia, 20 minutes after the Intervention injection and then every 30 minutes until the end of recovery. Method of measurement: ECG monitoring.;Oxygen saturation. Timepoint: Before surgery, after spinal anesthesia, 20 minutes after the Intervention injection and then every 30 minutes until the end of recovery. Method of measurement: Pulse oximeter.;Surgeon Satisfaction. Timepoint: After surgery. Method of measurement: Ask the surgeon.;Patient Satisfaction. Timepoint: After surgery. Method of measurement: Ask the patient.;Bleeding Rate. Timepoint: After surgical incision until the end of recovery. Method of measurement: Observing.	—

Measure

Time frame

Systolic Blood Pressure. Timepoint: Before surgery, after spinal anesthesia, 20 minutes after the Intervention injection and then every 30 minutes until the end of recovery. Method of measurement: Non-invasive blood pressure measurement.;Diastolic Blood Pressure. Timepoint: Before surgery, after spinal anesthesia, 20 minutes after the Intervention injection and then every 30 minutes until the end of recovery. Method of measurement: Non-invasive blood pressure measurement.;Heart Rate. Timepoint: Before surgery, after spinal anesthesia, 20 minutes after the Intervention injection and then every 30 minutes until the end of recovery. Method of measurement: ECG monitoring.;Oxygen saturation. Timepoint: Before surgery, after spinal anesthesia, 20 minutes after the Intervention injection and then every 30 minutes until the end of recovery. Method of measurement: Pulse oximeter.;Surgeon Satisfaction. Timepoint: After surgery. Method of measurement: Ask the surgeon.;Patient Satisfaction. Timepoint: After surgery. Method of measurement: Ask the patient.;Bleeding Rate. Timepoint: After surgical incision until the end of recovery. Method of measurement: Observing.

—

Secondary

Measure	Time frame
Nausea. Timepoint: Every 30 minutes after entering recovery. Method of measurement: Ask the patient.;Vomiting. Timepoint: Every 30 minutes after entering recovery. Method of measurement: Ask the patient.;Rate of Postoperative pain. Timepoint: Every 30 minutes after entering recovery. Method of measurement: Ask the patient.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMottahareh Rajabi Moghaddam

Esfahan University of Medical Sciences

Fakhari.hd@gmail.com+98 31 3620 2020

Outcome results

None listed

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