The effects of midazolam and dexmedetomidine in patients under stereotaxic surgery

Comparison of the effects of midazolam and dexmedetomidine on sedation levels, hemodynamics and complications in patients under brain stereotaxic surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160307026950N12

Enrollment

Registered

2019-06-06

Start date

2017-09-23

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

Condition 1: respiratory apnea. Condition 2: systolic and diastolic blood pressure. Condition 3: heart rate. Condition 4: drug sedation level. Condition 5: bleeding. Condition 6: oxygen saturation level. Apnea, not elsewhere classified Hypotension due to drugs Bradycardia, unspecified Sedatives, hypnotics and antianxiety drugs Haemorrhage and haematoma complicating a procedure, not elsewhere classified Asphyxia and hypoxemia

Interventions

Intervention 1: Intervention group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry,

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: patients candidates brain stereotaxic surgery age between 18 and 60 No history of allergic reaction to both midazolam and dexmedetomidin

Exclusion criteria

Exclusion criteria: any change in anesthesia or surgery plan due to any complication patient expiration during surgery

Design outcomes

Primary

Measure	Time frame
Systolic and diastolic blood pressure. Timepoint: preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery. Method of measurement: Non-invasive barometer.;Heart rate. Timepoint: preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery. Method of measurement: pulse oximetry device.;Respiratory rate. Timepoint: preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery. Method of measurement: Count in minute.;Drug sedation level. Timepoint: after end of surgery. Method of measurement: Ramsay sedation scale.;Patient satisfaction. Timepoint: after end of surgery. Method of measurement: Visual Analogue Scale.;Surgeon satisfaction. Timepoint: after end of surgery. Method of measurement: Iowa Satisfaction with Anesthesia Scale.;Recovery time. Timepoint: From the moment of finishing surgery to full recovery time. Method of measurement: In minute using a chronometer.;Bleeding. Timepoint: after end of surgery. Method of measurement: Bleeding above 50 cc.;Low blood oxygen saturation. Timepoint: during surgery. Method of measurement: The drop in oxygen saturation below 90% by pulse oximeter.;Respiratory apnea. Timepoint: during surgery. Method of measurement: Respiratory arrest for more than 8 seconds measured by chronometer.	—

Measure

Time frame

Systolic and diastolic blood pressure. Timepoint: preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery. Method of measurement: Non-invasive barometer.;Heart rate. Timepoint: preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery. Method of measurement: pulse oximetry device.;Respiratory rate. Timepoint: preoperative periods, 1, 3, 5, 10 and 20 minutes during surgery. Method of measurement: Count in minute.;Drug sedation level. Timepoint: after end of surgery. Method of measurement: Ramsay sedation scale.;Patient satisfaction. Timepoint: after end of surgery. Method of measurement: Visual Analogue Scale.;Surgeon satisfaction. Timepoint: after end of surgery. Method of measurement: Iowa Satisfaction with Anesthesia Scale.;Recovery time. Timepoint: From the moment of finishing surgery to full recovery time. Method of measurement: In minute using a chronometer.;Bleeding. Timepoint: after end of surgery. Method of measurement: Bleeding above 50 cc.;Low blood oxygen saturation. Timepoint: during surgery. Method of measurement: The drop in oxygen saturation below 90% by pulse oximeter.;Respiratory apnea. Timepoint: during surgery. Method of measurement: Respiratory arrest for more than 8 seconds measured by chronometer.

—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactmehdi khademi

Esfahan University of Medical Sciences

mehdi.kh199271@gmail.com+98 66 3330 9832

Outcome results

None listed

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