effects of spinal anesthesia with small dose of bupivacaine and sufentanil

Clinical trial for comparison of effect of small dose of bupivacaine and sufentanil and normal dose of bupivacaine on hemodynamic variables in patients that underwent lower limb orthopedic surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201012233954N6

Enrollment

150

Registered

2011-06-06

Start date

2009-12-22

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

spinal anesthesia. Unspecified adverse effect of drug or medicament

Interventions

Intervention 1: Case group with 75 patients underwent spinal anesthesia with 7.5 mg bupivacaeine 0.5% and 5 µg sufentanil and 0.5 mm saline. Intervention 2: control group: 75 cases that underwent spin

Treatment - Drugs

Case group with 75 patients underwent spinal anesthesia with 7.5 mg bupivacaeine 0.5% and 5 µg sufentanil and 0.5 mm saline.

control group: 75 cases that underwent spinal block with 15 mg bupivacaine.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who candidate for orthopedic lower limb surgery included in our study. Patients with ASA class 3 and 4; patients with contraindication for spinal anesthesia such as hemodynamic instability; refuse from spinal anesthesia; infection in site of spinal; raised CSF pressure and sensitivity to drugs excluded from our study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Blood Pressure. Timepoint: 1,3,5,10,15,30,60 min. Method of measurement: NIBP.	—

Secondary

Measure	Time frame
Need to catecholamine. Timepoint: time of need to catecholamine. Method of measurement: treatment of hypotension.;Onset of sensory block. Timepoint: 2 min iterval. Method of measurement: Pinprick test.;Maximum of sensory block. Timepoint: 2 min iterval. Method of measurement: Pinprick test.;Time of sensory block till T10. Timepoint: 2 min iterval. Method of measurement: Pinprick test.;Pain during operation. Timepoint: each time during operation. Method of measurement: request of patient.;Nausea. Timepoint: during operation. Method of measurement: subjective.;Vomiting. Timepoint: during operation. Method of measurement: subjective.;Purities. Timepoint: during operation. Method of measurement: subjective.;Intraoperative Bleeding. Timepoint: during operation. Method of measurement: mm.	—

Measure

Time frame

Need to catecholamine. Timepoint: time of need to catecholamine. Method of measurement: treatment of hypotension.;Onset of sensory block. Timepoint: 2 min iterval. Method of measurement: Pinprick test.;Maximum of sensory block. Timepoint: 2 min iterval. Method of measurement: Pinprick test.;Time of sensory block till T10. Timepoint: 2 min iterval. Method of measurement: Pinprick test.;Pain during operation. Timepoint: each time during operation. Method of measurement: request of patient.;Nausea. Timepoint: during operation. Method of measurement: subjective.;Vomiting. Timepoint: during operation. Method of measurement: subjective.;Purities. Timepoint: during operation. Method of measurement: subjective.;Intraoperative Bleeding. Timepoint: during operation. Method of measurement: mm.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahmood Karbasfroushan

Anesthesia and critical care department, Besat hospital, Hamedan Univerity of Meical Sciences, Hamed

alizadehlab@yahoo.com+98 912 688 3770

Outcome results

None listed

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