The effects of hyperbaric and isobaric bupivacaine on the Bispectral Index in cesarean section with spinal anesthesia

Comparison of the effects of hyperbaric and isobaric bupivacaine on the Bispectral Index in parturients undergoing cesarean section with spinal anesthesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201201162405N9

Enrollment

Registered

2012-01-29

Start date

2009-06-27

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

Complications of anesthesia during pregnancy. Other complications of anesthesia during pregnancy

Interventions

Intervention 1: 2.5 cc hyperbaric bupivacaine 0.5%. Duration of intervention: single dose in 10 seconds spinal injection. Duration of treatment: During spinal anesthesia in operating room. Interventio

Treatment - Drugs

2.5 cc hyperbaric bupivacaine 0.5%. Duration of intervention: single dose in 10 seconds spinal injection. Duration of treatment: During spinal anesthesia in operating room

2.5 cc isorbaric bupivacaine 0.5%. Duration of intervention: single dose in 10 seconds spinal injection. Duration of treatment: During spinal anesthesia in operating room

Eligibility

Sex/Gender

Female

Age

15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Parturients; ASA physical status I-II; scheduled for elective cesarean section; using spinal anesthesia; Exclusion Criteria: suspicious to bleeding disturbances; atopia; diabetes mellitus; presence of liver or kidney diseases; drugs abuse; complicated pregnancy; preeclampsia

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Bispecteral Index. Timepoint: at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection. Method of measurement: with attachment of probes of Cerebral Status Monitoring to the parturient.	—

Secondary

Measure	Time frame
Signal Quality Index. Timepoint: at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection. Method of measurement: with attachment of probes of Cerebral Status Monitoring to the parturient.;Electromyography. Timepoint: at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection. Method of measurement: with attachment of probes of Cerebral Status Monitoring to the parturient.;Temperature. Timepoint: at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection. Method of measurement: with tympanometer from the tympanic membrane.	—

Measure

Time frame

Signal Quality Index. Timepoint: at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection. Method of measurement: with attachment of probes of Cerebral Status Monitoring to the parturient.;Electromyography. Timepoint: at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection. Method of measurement: with attachment of probes of Cerebral Status Monitoring to the parturient.;Temperature. Timepoint: at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection. Method of measurement: with tympanometer from the tympanic membrane.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mitra Jabalameli

Isfahan University of Medical Sciences

jabalameli@med.mui.ac.ir+98 31162555551532

Outcome results

None listed

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