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Effects of intrathecal midazolam on block characteristic and control of postoperative pain

Clinical trial comparison of addition of Midazolam or Normal Saline to Bupivacaine in spinal anesthesia in patients with fracture of lower extremities

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016063028712N1
Enrollment
80
Registered
2017-01-06
Start date
2016-12-21
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

Regional anesthesia. Local anesthetics

Interventions

Intervention 1: Intervention group: Spinal anesthesia will be done with 17.5 mg bupivacain 0.5% in 3.5 ml plus 2/5 mg midazolam in 0.5 ml (total volume 4 ml) in study group. Intervention 2: Control
Treatment - Drugs
Intervention group: Spinal anesthesia will be done with 17.5 mg bupivacain 0.5% in 3.5 ml plus 2/5 mg midazolam in 0.5 ml (total volume 4 ml) in study group
Control group: Spinal anesthesia will be done with 17.5 mg bupivacain 0.5% in 3.5 ml plus 0.5 ml normal salin (total volume 4 ml) in control group .

Sponsors

Vice chancellor for research of Kurdistan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) take Informed consent to enter the study; 2) patients between 20-70 old age; 3) Physical status 1 and 2 classification of "American Society of Anesthesiologists"(ASA). Exclusion criteria: 1) Ischemic heart disease; 2) Hypertension; 3) Uncontrolled diabetes; 4) Valvular heart disease; 5) Coagulopathy; 6) Lumbar spinal column deformity; 7) Block failure due to technical problems; 8) Needs to extra sedative drugs.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Intensity of sensory block. Timepoint: During first ten minute after block. Method of measurement: Cold cotton.;Intensity of motor block. Timepoint: During first ten minute after block. Method of measurement: Bromage scale.;Duration of sensory block. Timepoint: The time to regresion of sensory block to S1 in PACU. Method of measurement: Cold cotton.;Duration of motor block. Timepoint: The time to regression of motor block to bromage 1 in PACU. Method of measurement: Bromage scale.

Secondary

MeasureTime frame
Pain scale. Timepoint: In discharge time and three houre later. Method of measurement: Numerical rating scale.;Nausea and vomiting. Timepoint: Time of block until discharge from recovery(PACU). Method of measurement: Questionnaire.;Shivering. Timepoint: Time of block until discharge from recovery(PACU). Method of measurement: Observation of face and extermitis.;Hypotension. Timepoint: First 15 minute after block every 2 minute and then every 15 minute. Method of measurement: Monitoring.;Bradycardia. Timepoint: First 15 minute after block every 2 minute and then every 15 minute. Method of measurement: Monitoring.;The time to first analgesic request. Timepoint: 3 houre after discharge of recovery. Method of measurement: File.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Farzad Sarshivi

Kurdistan University of Medical Sciences

farzadsarshivi@gmail.com+98 87 3366 4645

Outcome results

None listed

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