Comparison of the effect of midazolam, fentanyl and placebo on hemodynamic changes caused by spinal anesthesia

Comparison of the effect of midazolam, fentanyl and placebo on hemodynamic changes caused by spinal blocks in pregnant women undergoing cesarean section referred to valiasr hospital

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201704085225N7

Enrollment

105

Registered

2017-05-10

Start date

2017-05-22

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

Cesarean Section. Single delivery by caesarean section

Interventions

Intervention 1: Intravenous injection of 1 mg midazolam (diluted in 1 ml). Intervention 2: Intravenous injection of 50 micrograms of fentanyl (1 ml). Intervention 3: Intravenous placebo included (1 ml

Intravenous injection of 1 mg midazolam (diluted in 1 ml)

Intravenous injection of 50 micrograms of fentanyl (1 ml)

Intravenous placebo included (1 ml of distilled water)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Major inclusion criteria: women undergoing cesarean section Major exclusion criteria: drop in the fetal heart rate; sensitivity to fentanyl and midazolam.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Diastolic blood pressure. Timepoint: Before induction of anesthesia, after induction of spinal anesthesia in minutes 1-2-3-4-5-10-15-20-25. Method of measurement: using Sphygmomanometer in mmHg.;Systolic blood pressure. Timepoint: Before induction of anesthesia, after induction of spinal anesthesia in minutes 1-2-3-4-5-10-15-20-25. Method of measurement: using Sphygmomanometer in mmHg.;Heart beat. Timepoint: Before induction of anesthesia, after induction of spinal anesthesia in minutes 1-2-3-4-5-10-15-20-25. Method of measurement: Based on the number of beats per minute on heart rate monitoring.	—

Measure

Time frame

Diastolic blood pressure. Timepoint: Before induction of anesthesia, after induction of spinal anesthesia in minutes 1-2-3-4-5-10-15-20-25. Method of measurement: using Sphygmomanometer in mmHg.;Systolic blood pressure. Timepoint: Before induction of anesthesia, after induction of spinal anesthesia in minutes 1-2-3-4-5-10-15-20-25. Method of measurement: using Sphygmomanometer in mmHg.;Heart beat. Timepoint: Before induction of anesthesia, after induction of spinal anesthesia in minutes 1-2-3-4-5-10-15-20-25. Method of measurement: Based on the number of beats per minute on heart rate monitoring.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Seyed Mohammad Mireskandari

Valiasr Hospital

mireskandari@sina.tums.ac.ir+98 21 6119 2386

Outcome results

None listed

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