The effect of hyperbaric bupivacaine dosage on the incidence and severity of early complications after spinal anesthesia for orthopedic surgeries

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160202026328N7

Enrollment

Registered

2022-01-10

Start date

2021-12-22

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

Complications of spinal anesthesia. Other complications of anesthesia

Interventions

Intervention 1: Intervention group A: Three groups named A, B and C, which are defined based on the dose of hyperbaric bupivacaine 0.5% injection into the intrathecal space. In all three groups, in or

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age 18 to 60 years Orthopedic lower limb surgeries Having an indication for spinal anesthesia Patients with ASA class I and II

Exclusion criteria

Exclusion criteria: Patient discontent with spinal anesthesia Uncontrolled blood pressure in the patient Uncontrolled diabetes in the patient History of previous neurological problems in the patient Presence of coagulation problems in the patient Hypersensitivity to anesthetics Septicemia or local infection at the site of needle entry

Design outcomes

Primary

Measure	Time frame
Blood pressure. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: In millimeters of mercury using a non-invasive method of measuring blood pressure by the device.;Heart rate. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: Beat Per minute using a non-invasive heart rate monitor.;Hypoventilation and hypoxia. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: Monitoring the respiratory rate per minute and measuring oxygen saturation by pulse oximetry.;Nausea and vomiting. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: Asking the patient.	—

Measure

Time frame

Blood pressure. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: In millimeters of mercury using a non-invasive method of measuring blood pressure by the device.;Heart rate. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: Beat Per minute using a non-invasive heart rate monitor.;Hypoventilation and hypoxia. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: Monitoring the respiratory rate per minute and measuring oxygen saturation by pulse oximetry.;Nausea and vomiting. Timepoint: Immediately after becoming supine and then at intervals of 5 minutes to half an hour and then every 15 minutes to an hour. Method of measurement: Asking the patient.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Parish

Tabriz University of Medical Sciences

parishm@tbzmed.ac.ir+98 41 3385 5842

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026