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Effect of adding fentanyle and sufentanil to bupivacaine in spinal anesthesia in perioperative complications of orthopedic surgery

A comparative evaluation of perioperative complications of intrathecal sufentanil and fentanyl in combination with bupivacaine and bupivacaine alone for lower limb orthopedic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201209045822N2
Enrollment
90
Registered
2012-10-14
Start date
2011-03-21
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

lower limb bone fracture. Disorders of continuity of bone

Interventions

Intervention 1: sufentanil Group: we will administrate intrathecally 15mg Bupivacaine 0.5% (Bupivacaine®? Milan Co? Italy) with 5 microgram Sufetanil (Sufenta? Janssen-Cilag, India). Intervention 2:
Treatment - Drugs
sufentanil Group: we will administrate intrathecally 15mg Bupivacaine 0.5% (Bupivacaine®? Milan Co? Italy) with 5 microgram Sufetanil (Sufenta? Janssen-Cilag, India)
Fentnyll group: we will administrate intrathecally 15mg Bupivacaine 0.5% (Bupivacaine®? Milan Co? Italy) with 25 microgram fetanyl (Fentanyl, Abureyhan, Iran)
Control group: we will administrate intrathecally 15mg Bupivacaine 0.5% (Bupivacaine®? Milan Co? Italy) with 0.5 ml Distilled water

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: adults aged 18-65 years; American Society of Anesthesiology classification of 1-2; No contraindication for spinal anesthesia; No history of opium abuse; No history of neurologic, neuromuscular or psychological disorders; no history of allergic reaction to local anesthetic Exclusion criteria: request for analgesic drugs or opioids during spinal anesthesia; need for general anesthesia during operation; pregnancy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mean Arterial Pressure. Timepoint: every 2 min til 20 min, then every 5 min until transfering the patient to the recovery then every 15 min until transfering to the ward. Method of measurement: Electronic sphygmometer.

Secondary

MeasureTime frame
O2 Saturation. Timepoint: every 2 min til 20 min, then every 5 min until transfering the patient to the recovery then every 15 min until transfering to the ward. Method of measurement: pulse oximetry.;Heart rate. Timepoint: every 2 min til 20 min, then every 5 min until transfering the patient to the recovery then every 15 min until transfering to the ward. Method of measurement: pulse oximetry.;Maximum height of sencory block. Timepoint: 10 min after intervention. Method of measurement: physcial examination.;Ephedrin administration. Timepoint: when blood pressure decrease to20% of base or below 100mmhg. Method of measurement: yes/ no.;Bradicardia. Timepoint: when Heart rate decreases below 60 per min. Method of measurement: pulse oximetry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactValiollah Hassani

Tehran University of Medical Sciences

vhassani@yahoo.com+98 21 6650 9059

Outcome results

None listed

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