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Comparison of the effect of intravenous Dexamethasone injection with Intrathecal injection On Pain and Nausea and Vomiting of patients undergoing Caesarean section

Comparison of the effect of intravenous Dexamethasone injection with Intrathecal injection On Pain and Nausea and Vomiting of patients undergoing Caesarean section by Spinal anesthesia with Sufentanil; a double-blind randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141001019359N16
Enrollment
90
Registered
2022-11-21
Start date
2022-12-20
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Condition 1: Pain. Condition 2: Nausea and Vomiting. Pain, unspecified Nausea with vomiting, unspecified

Interventions

Intervention 1: Intervention group 1: In combination with the main drug (bupivacaine)
patients will receive 25 microgram Sufentanyl and 8 mg Dexamethasone Intrathecally (2cc). Also, immediately after doing the spinal
All patients will receive 2cc of Distilled water intravenously. Intervention 2: Intervention group 2:In combination with the main drug (bupivacaine)
patients will receive 25 microgram Sufentanyl and 2cc of Distilled water Intrathecally. Also, immediately after doing the spinal
All patients will receive 8 mg of dexamethasone (2cc) intravenously. Intervention 3: Control group: In combination with the main drug (bupivacaine)
All patients will receive 2cc of Distilled water intravenously.

Sponsors

Bojnourd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patient should not have the Absolute contraindications for spinal anesthesia. The patient should not have a history of previous surgery. The patient should not have mental and psychological problems and peripheral and central neuropathy. The patient should not have cardiovascular problems. ASA I & II Patients must be vigilant

Exclusion criteria

Exclusion criteria: Patients who are addictive or have drug abuse. Patient who has a history of taking beta blockers and Alpha 2-agonists and Calcium Channel Blockers. For any reason, If we have to perform General Anesthesia after Spinal Anesthesia

Design outcomes

Primary

MeasureTime frame
Pain after surgery. Timepoint: During recovery, 30 minutes after surgery and then every 30 minutes until the 2th hour, then at 6, 12 and 24 hours after surgery. Method of measurement: Visual Analog Score (VAS).;Nausea and Vomiting. Timepoint: During recovery, 30 minutes after surgery and then every 30 minutes until the 2th hour, then at 6, 12 and 24 hours after surgery. Method of measurement: Scale for measuring nausea and vomiting.

Secondary

MeasureTime frame
Level of analgesia. Timepoint: After spinal procedure. Method of measurement: Pin Prink Index.;Duration of analgesia. Timepoint: After the patient leaves the operation room. Method of measurement: Clock.;Hemodynamic parameters. Timepoint: After performing the spinal technique, in the first 15 minutes every 5 minutes and then every 15 minutes until the end of the surgery. Method of measurement: Using the monitoring device.;Medication side effects. Timepoint: From the end of surgery to 24 hours after. Method of measurement: Researcher-made questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Esmaeili

Bojnourd University of Medical Sciences

dresmaely8@gmail.com0098583151

Outcome results

None listed

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