Evaluation of the effectiveness of dexmedetomidine with sufentanil in combination with intrathecal ropivacaine on analgesia in cesarean section

Comparative study of the effectiveness of dexmedetomidine with sufentanil in adding intrathecal ropivacaine on analgesia in the elective cesarean section - A Randomized Double-Blind Clinical Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201212049688N1

Enrollment

136

Registered

2021-05-18

Start date

2021-04-19

Completion date

Unknown

Last updated

2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean section. Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section

Interventions

Intervention 1: Intervention group: In the first intervention group, 5 micrograms of dexmedetomidine and 12.5 micrograms of isobaric ropivacaine 0.5% are injected intrathecally into the subarachnoid

Eligibility

Sex/Gender

All

Age

18 Years to 30 Years

Inclusion criteria

Inclusion criteria: singleton and term pregnant women 18 to 45 years. Having a body mass of 18 to 30. Patients referred for elective cesarean section, who are classified as Class I according to the American Society of Anesthesiology (A.S.A).

Exclusion criteria

Exclusion criteria: Having any underlying disease History of allergy to local anesthetic Coagulation disorders, local skin infection at the site of spinal anesthesia Surgery Emergency cesarean section Cases where we have to undergo general anesthesia during surgery

Design outcomes

Primary

Measure	Time frame
Time of onset of analgesia. Timepoint: 1,2,4,6,8,10,12,16,20,24 hours after the end of the surgery. Method of measurement: With Visual Analog Scale.;Duration of analgesia. Timepoint: 1,2,4,6,8,10,12,16,20,24 hours after the end of the surgery. Method of measurement: With Visual Analog Scale.	—

Secondary

Measure	Time frame
Blood pressure changes. Timepoint: In minutes 1,5,10,15,20,25,30,60 after injection. Method of measurement: By barometer and registration in the relevant forms.;Nausea. Timepoint: After the intervention. Method of measurement: By asking the patient questions and observing objectively.;Vomiting. Timepoint: After the intervention. Method of measurement: By asking the patient questions and observing objectively.;Headache. Timepoint: After the intervention. Method of measurement: By Visual Analog Scale.;Heart rate. Timepoint: In minutes 1,5,10,15,20,25,30,60 after injection. Method of measurement: By pulse oximeter.;Respiratory distress. Timepoint: After the intervention. Method of measurement: By objective observation.	—

Measure

Time frame

Blood pressure changes. Timepoint: In minutes 1,5,10,15,20,25,30,60 after injection. Method of measurement: By barometer and registration in the relevant forms.;Nausea. Timepoint: After the intervention. Method of measurement: By asking the patient questions and observing objectively.;Vomiting. Timepoint: After the intervention. Method of measurement: By asking the patient questions and observing objectively.;Headache. Timepoint: After the intervention. Method of measurement: By Visual Analog Scale.;Heart rate. Timepoint: In minutes 1,5,10,15,20,25,30,60 after injection. Method of measurement: By pulse oximeter.;Respiratory distress. Timepoint: After the intervention. Method of measurement: By objective observation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHanieh Azadifar

Kermanshah University of Medical Sciences

hooman.rafiee@yahoo.com+98 83 3427 6300

Outcome results

None listed

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