Clinical trial the effect of intrathecal opioid on bispectral index in patient with lower limb orthopedic surgery under spinal anesthesia.

The effect of intrathecal fentanyl on bispectral index during spinal anesthesia in patients with lower limb orthopedic surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016080627677N4

Enrollment

Registered

2016-08-28

Start date

2015-08-23

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

sedation in spinal anesthesia. Unspecified adverse effect of drug or medicament

Interventions

Intervention 1: Intervention group: will receive hyperbaric bupivacaine with intrathecal fentanyl. In sitting position lumbar puncture will done using a 25 gauge needle (Exel) into the subarachnoid sp

Diagnosis

Intervention group: will receive hyperbaric bupivacaine with intrathecal fentanyl. In sitting position lumbar puncture will done using a 25 gauge needle (Exel) into the subarachnoid space L3-L4 in the

Control group: will receive alone hyperbaric bupivacaine .In sitting position lumbar puncture will done using a 25 gauge needle (Exel) into the subarachnoid space L3-L4 in the midline just cephalad. A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: physical status class I from the perspective of America society of Anesthesiologists; lower limb orthopedic surgery with spinal anesthesia; Lack of opioid addiction Exclusion criteria: spinal anesthesia contraindications; any unusual complications including a lot of bleeding during surgery; prolonged surgery

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Level of consciousness. Timepoint: Bispectral index will be recorded at baseline and 5, 10, 15, 30, 45 and 60 minutes after spinal injection. Method of measurement: Bispectral Index Monitoring.	—

Secondary

Measure	Time frame
Mean Arterial Blood Pressure. Timepoint: Mean Arterial Pressure will be recorded 5, 10, 15, 30, 45 and 60 minutes after spinal injection at baseline. Method of measurement: None Invasive Blood Pressure.;Heart Rate. Timepoint: Heart Rate will be recorded 5, 10, 15, 30, 45 and 60 minutes after spinal injection at baseline. Method of measurement: Electrocardiogram.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahryar Sane

Urmia University of Medical Sciences

sane.sh@umsu.ac.ir" ;" shahryarsane@yahoo.com" ;" dr.sh.sane@gmail.com+98 44332234897

Outcome results

None listed

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