Comparison of the effect of Fentanyl with Dexmedetomidine on post operative pain of cesarean section

Comparison of the effect of intrathecal Bupivacaine and Fentanyl with Bupivacaine and Dexmedetomidine on post operative pain of cesarean section in Shariati Hospital of Bandar Abbas in 2014

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015052722449N1

Enrollment

110

Registered

2015-11-02

Start date

2014-03-21

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

Complication of Anesthesia during pregnancy. other Complication of Anesthesia during pregnancy

Interventions

Intervention 1: Group 2: Intrathecal 10 mg bupivacaine 0.5% plus 25 microgram fentanyl. Intervention 2: Group 1: Intrathecal 10 mg bupivacaine 0.5% plus 5 microgram dexmedetomidin.

Treatment - Drugs

Group 2: Intrathecal 10 mg bupivacaine 0.5% plus 25 microgram fentanyl

Group 1: Intrathecal 10 mg bupivacaine 0.5% plus 5 microgram dexmedetomidin

Eligibility

Sex/Gender

Female

Age

15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Gestational age 37 weeks or higher; ASA I-II Exclusion criteria: Emergency patients; patients with valvular Heart disease; patients with history of Allergy to local anesthetic drugs; addiction and alcoholism; placenta previa; patients with incomplete spinal block who require analgesic agents; patients with contraindication for regional anesthesia

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Post operative pain. Timepoint: Recovery time and 1 - 3 - 6 hours after operation. Method of measurement: VAS (visual analogue scale).;The duration of complete return of lower extremities movement (Modified Bromage Scale = 0). Timepoint: Recovery time and 1 - 3 - 6 hours after operation. Method of measurement: Lower extremities movement (modified Bromage scale ).	—

Secondary

Measure	Time frame
Respiratory depression. Timepoint: For 6 hours after block initiation. Method of measurement: respiratory rate less than 10 per minute.;Nausea and vomiting. Timepoint: For 6 hours after block initiation. Method of measurement: Questionnaire (Yes or NO).;Shivering. Timepoint: For 6 hours after block initiation. Method of measurement: Questionnaire (Yes or NO).;Blood pressure. Timepoint: Before injection and immediately after injection and at 5-10-15-30-60 minutes after injection and at recovery. Method of measurement: Automated sphygmomanometer.;Heart rate. Timepoint: Before injection and immediately after injection and at 5-10-15-30-60 minutes after injection and at recovery. Method of measurement: heart rate monitoring device.	—

Measure

Time frame

Respiratory depression. Timepoint: For 6 hours after block initiation. Method of measurement: respiratory rate less than 10 per minute.;Nausea and vomiting. Timepoint: For 6 hours after block initiation. Method of measurement: Questionnaire (Yes or NO).;Shivering. Timepoint: For 6 hours after block initiation. Method of measurement: Questionnaire (Yes or NO).;Blood pressure. Timepoint: Before injection and immediately after injection and at 5-10-15-30-60 minutes after injection and at recovery. Method of measurement: Automated sphygmomanometer.;Heart rate. Timepoint: Before injection and immediately after injection and at 5-10-15-30-60 minutes after injection and at recovery. Method of measurement: heart rate monitoring device.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Sharifi

Hormozgan University of Medical Sciences

dr.msh53@yahoo.com+98 76 3334 7009

Outcome results

None listed

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