Comparison of the effect of drug combination in lower back anesthesia on duration of effect and changes in heart rate and blood pressure in patients undergoing orthopedic surgery with lower limb fractures

Comparison the effect of combined of (bupivacaine + magnesium sulfate) with combined (pethidine + magnesium sulfate) and sole pethidine in spinal anesthesia on effect of duration and hemodynamic changes in patients under Lower Limb orthopedic surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170413033408N3

Enrollment

120

Registered

2020-06-11

Start date

2020-08-20

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

Lower Limb fracture. Disorder of bone, unspecified

Interventions

Intervention 1: Intervention group: Group A patients will receive Intrathecal magnesium sulfate with 100 mg bupivacaine at a dose of 10 mg. Intervention 2: Intervention group: Group B will be patients

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patient with lower limb fracture candidate for orthopedic surgery which can be performed under spinal anesthesia Signing a consent form Class 1 or 2 of the physical condition of the American Anesthesia Association ASA Age range 18-60 years Elective surgery

Exclusion criteria

Exclusion criteria: High intracranial pressure Infection in site of injection Impossible of proper position History of allergy with bupivacaine or pethidine

Design outcomes

Primary

Measure	Time frame
The duration of the anesthetic effect. Timepoint: The duration of anesthesia will be recorded every minute immediately after intravenous injection until the onset of sensory block and every 5 minutes until sensory level stabilization. Method of measurement: Using a blunt needle and register in the checklist.;Hemodynamic change. Timepoint: Hemodynamic changes in the operating room will be measured every 5 minutes until the end of the first 30 minutes, then every 15 minutes until the end of surgery. The recovery room will record every 15 minutes until recovery criteria are met. Method of measurement: Hemodynamic criteria (heart rate, systolic, diastolic, and mean arterial blood pressure (MABP), arterial oxygen saturation) of the patient will be measured by Saadat monitoring.	—

Measure

Time frame

The duration of the anesthetic effect. Timepoint: The duration of anesthesia will be recorded every minute immediately after intravenous injection until the onset of sensory block and every 5 minutes until sensory level stabilization. Method of measurement: Using a blunt needle and register in the checklist.;Hemodynamic change. Timepoint: Hemodynamic changes in the operating room will be measured every 5 minutes until the end of the first 30 minutes, then every 15 minutes until the end of surgery. The recovery room will record every 15 minutes until recovery criteria are met. Method of measurement: Hemodynamic criteria (heart rate, systolic, diastolic, and mean arterial blood pressure (MABP), arterial oxygen saturation) of the patient will be measured by Saadat monitoring.

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Countries

Iran (Islamic Republic of)

Contacts

Public Contactdr Babak Mojaver Aghilli

Gorgan University of Medical Sciences

drbabaka35@gmail.com+98 17 3115 3566

Outcome results

None listed

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