Determination of effective local anesthetic dose in spinal anesthesia

Comparison of two different doses of 0.5 % bupivacaine added to sufentanil intrathecal on sensory block and incidence of hypotension in cesarean section under spinal anesthesia.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017030510841N7

Enrollment

100

Registered

2017-06-02

Start date

2017-01-20

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

Hypotension & sensory block level during spinal anesthesia in c/s. Other complications of spinal and epidural anaesthesia during labour and delivery

Interventions

Intervention 1: In intervention group: After entering patients into operating room they receive 10 ml/kg ringer solution through a 18 G intravenous catheter. They will be anesthetized with spinal

Prevention

In intervention group: After entering patients into operating room they receive 10 ml/kg ringer solution through a 18 G intravenous catheter. They will be anesthetized with spinal block in a sit

In control group: After entering patients into operating room they receive 10 ml/kg ringer solution through a 18 G intravenous catheter. They will be anesthetized with spinal block in a sitting

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 18-45 years old patients with ASA class 1&2; Term pregnancy(Gestational age 36-40 week) and candidate for cesarean section under spinal anesthesia. Exclusion criteria: High risk and Multiple pregnancy; Emergency cesarean section; Pre-eclampcia and eclampcia; Cardio vascular disorders; Respiratory disoeders; Thyroid diseases; Hypertension and spinal anesthesia contraindications( Patient refusal; Increasing of intracranial pressure; Regional infection; Coagulopathy; Anemia and hypovolemia).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Consumption of aropin. Timepoint: end of surgery and recovery. Method of measurement: mg and by observation & calculation.;Consumption of ephedrine. Timepoint: end of surgery and recovery. Method of measurement: mg and by observation & calculation.;SPO2. Timepoint: 1,2,3,4,5,10,15,20,30,40,50,60 minutes after spinal anesthesia. Method of measurement: Percent and by pulse oxymetry.;Sensory block level. Timepoint: before surgery and recovery. Method of measurement: determination of sensory level by needle (pinprick).;Motor block level. Timepoint: before surgery and recovery. Method of measurement: bromage score.;Systolic and diastolic blood presure. Timepoint: 1,2,3,4,5,10,15,20,30,40,50,60 minutes after spinal anesthesia. Method of measurement: mm Hg & by automatic non invasive blood pressure.;Mean arterial pressure. Timepoint: 1,2,3,4,5,10,15,20,30,40,50,60 minutes after spinal anesthesia. Method of measurement: mm Hg & by automatic non invasive blood pressure.;Heart Rate. Timepoint: 1,2,3,4,5,10,15,20,30,40,50,60 minutes after spinal anesthesia. Method of measurement: Beat per minute and by ECG monitoring.;New born Apgar. Timepoint: 1&5 minutes after delivery. Method of measurement: Apgar Score.;Determination of pain. Timepoint: skin incision,neonate delivery,skin closure ,recovery. Method of measurement: visual analgesic scale(10 cm ruler).	—

Measure

Time frame

Consumption of aropin. Timepoint: end of surgery and recovery. Method of measurement: mg and by observation & calculation.;Consumption of ephedrine. Timepoint: end of surgery and recovery. Method of measurement: mg and by observation & calculation.;SPO2. Timepoint: 1,2,3,4,5,10,15,20,30,40,50,60 minutes after spinal anesthesia. Method of measurement: Percent and by pulse oxymetry.;Sensory block level. Timepoint: before surgery and recovery. Method of measurement: determination of sensory level by needle (pinprick).;Motor block level. Timepoint: before surgery and recovery. Method of measurement: bromage score.;Systolic and diastolic blood presure. Timepoint: 1,2,3,4,5,10,15,20,30,40,50,60 minutes after spinal anesthesia. Method of measurement: mm Hg & by automatic non invasive blood pressure.;Mean arterial pressure. Timepoint: 1,2,3,4,5,10,15,20,30,40,50,60 minutes after spinal anesthesia. Method of measurement: mm Hg & by automatic non invasive blood pressure.;Heart Rate. Timepoint: 1,2,3,4,5,10,15,20,30,40,50,60 minutes after spinal anesthesia. Method of measurement: Beat per minute and by ECG monitoring.;New born Apgar. Timepoint: 1&5 minutes after delivery. Method of measurement: Apgar Score.;Determination of pain. Timepoint: skin incision,neonate delivery,skin closure ,recovery. Method of measurement: visual analgesic scale(10 cm ruler).

—

Secondary

Measure	Time frame
Pruritis. Timepoint: during surgery. Method of measurement: Observation &visual scale.;Nausea &vomiting. Timepoint: during sergury and in recovery. Method of measurement: Observation and questioning the patient.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNahid Manouchehrian

Hamadan University of Medical Science-Fatemie Hospital

manuchehriann@gmail.com+98 81 3827 7012

Outcome results

None listed

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