Effect of Intrathecal midazolam , Pethidine and Bupivacaine on Analsgesia, Hemodynamic Status and Nausea and Vomiting After Elective Cesarean Section

A Clinical trial Of Analgesic Effects, Hemodynamic Changes And Postoperative Nausea And Vomiting After Intrathecal Injection Of Bupivacaine Plus Midazolam , Bupivacaine Plus Pethidine Or Bupivacaine Alone In Elective Cesarean Section

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014102719145N2

Enrollment

Registered

2014-11-12

Start date

2014-10-20

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

Spinal Block in elective cesarean.

Interventions

Intervention 1: Group I (control): 10 milligram bupivacaine 5%. Intervention 2: Group II (intervention): 10 milligram bupivacaine 5% plus 25 milligram pethidine. Intervention 3: Group III (interventio

Treatment - Drugs

Group I (control): 10 milligram bupivacaine 5%

Group II (intervention): 10 milligram bupivacaine 5% plus 25 milligram pethidine

Group III (intervention): 10 milligram bupivacaine 5% plus 2.5 miligram midazolam

Eligibility

Sex/Gender

Female

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Full-term pregnant women; candidate for non-emergent cesarean section (elective cesarean, previous cesarean, cephalopelvic disproportion, malpresentation); American Society of Anesthesiologists physical status I or II Exclusion Criteria: contraindication for intrathecal injection; allergy to midazolam or pethidine; systemic diseases (such as diabetes, hypertension and preeclampsia)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: Immediately after termination of spinal block, thereafter with 30 minutes intervals until 4 hours. Method of measurement: Visual Analog Scale.;Need for first dose of analgesic agent. Timepoint: Immediately after termination of spinal block, thereafter with 30 minutes intervals until 4 hours. Method of measurement: Patient's request.;Heart Rate. Timepoint: Before operation, immediately after spinal block, thereafter with 15 minute intervals until 90 minute,immediately after termination of spinal block, 30 minutes after termination of spinal blocks. Method of measurement: Heart Rate monitoring.;Blood Pressure. Timepoint: Before operation, immediately after spinal block, thereafter with 15 minute intervals until 90 minute, immediately after termination of spinal block, 30 minutes after termination of spinal blocks. Method of measurement: Blood Pressure monitoring.;Nausea and Vomiting. Timepoint: Immediately after spinal block, 30 minutes later, one, two and four hours later. Method of measurement: Observing the patient.	—

Measure

Time frame

Pain. Timepoint: Immediately after termination of spinal block, thereafter with 30 minutes intervals until 4 hours. Method of measurement: Visual Analog Scale.;Need for first dose of analgesic agent. Timepoint: Immediately after termination of spinal block, thereafter with 30 minutes intervals until 4 hours. Method of measurement: Patient's request.;Heart Rate. Timepoint: Before operation, immediately after spinal block, thereafter with 15 minute intervals until 90 minute,immediately after termination of spinal block, 30 minutes after termination of spinal blocks. Method of measurement: Heart Rate monitoring.;Blood Pressure. Timepoint: Before operation, immediately after spinal block, thereafter with 15 minute intervals until 90 minute, immediately after termination of spinal block, 30 minutes after termination of spinal blocks. Method of measurement: Blood Pressure monitoring.;Nausea and Vomiting. Timepoint: Immediately after spinal block, 30 minutes later, one, two and four hours later. Method of measurement: Observing the patient.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahshid Abdollahi

Fasa University of Medical Sciences

abdollahi.m4@gmail.com+98 73 1221 6300

Outcome results

None listed

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