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Search / Trial NCT03458078

Analgesic Efficacy of Two Adjuvants During Spinal Anaesthesia.

Launched by CENTRE DE MATERNITÉ DE MONASTIR · Mar 1, 2018

Trial Information

Current as of August 02, 2025

Completed

Keywords

Bupivacaine, Anesthetics Adjuvants Analgesics Peripheral System Central Nervous Sensory System Agents Physiological Effects Of Drugs Opioid Pain Postoperative Signs And Symptoms

ClinConnect Summary

The patients were randomly allocated using a computer-generated randomization list to one of three groups that contained 50 parturients each via www.randomization.com.

Group C (control group): 10 mg hyperbaric bupivacaine 0.5% (2 ml) + 100γ morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 1 ml physiological saline.

Group Mg (magnesium sulfate group): 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 100 mg MgSO4 (1 ml).

Group MDZ (midazolam group): 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ Sufentanil (0.5ml) + 2mg Midazola...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • a mono fetal pregnancy, term\> 35 week, planned caesarean section under spinal anesthesia, six-hour fasting, and the American Society of Anesthesiologists (ASA) physical status I or II.
  • Exclusion Criteria:
  • contraindication for intrathecal injection, known allergies to midazolam, other benzodiazepines, magnesium sulfate, caesarean section in extreme urgency, preeclamptic parturient, foetal death in utero, premature delivery (\<32SA), anomaly of the placentation, any significant cardiovascular or hepatorenal diseases, a history of seizures or convulsive neurological disease, an altered coagulation profile. Exclusion criteria: failure of spinal anesthesia, conversion into general anesthesia, anesthetic or surgical perioperative incident requiring resuscitation, traumatic puncture, occurrence of serious complication of spinal anesthesia, loss of blindness or randomization of patients.

About Centre De Maternité De Monastir

The Centre de Maternité de Monastir is a renowned healthcare institution dedicated to maternal and child health, situated in Monastir, Tunisia. With a commitment to advancing obstetric and neonatal care, the center actively engages in clinical research to enhance medical practices and improve patient outcomes. Utilizing state-of-the-art facilities and a multidisciplinary team of experienced healthcare professionals, the Centre de Maternité de Monastir conducts clinical trials that focus on innovative treatments and practices in maternity care, ensuring adherence to the highest ethical and scientific standards. Through its research initiatives, the center aims to contribute valuable insights to the global medical community while providing exceptional care to its patients.

Locations

Mahdia, , Tunisia

Monastir, , Tunisia

Patients applied

0 patients applied

Trial Officials

Rim Cherif, Dr.

Study Director

CHU TAHAR SFAR MAHDIA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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