Comparison of the Analgesic Efficacy of Two Adjuvants to Hyperbaric Bupivacaine During Spinal Anaesthesia for Caesarean Section.
Description:
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 Midazolam (0.4 + 0.6cc physiological saline (1 ml)).
The parturients as well as the anesthetist who evaluated the protocol did not know the nature
of the adjuvant injected in spinal anesthesia. The presented syringe contained one of the two
adjuvants or the physiological serum in the same volume and of the same appearance. It was
prepared by an anesthesist who was not included in the analysis of the study and was
presented anonymously to the anesthetist in charge of the patient. A postoperative monitoring
(PO) was performed during the first 24 hours in the intensive care unit by the anesthesist
who did not know the nature of the injected adjuvant. All patients were kept nil per os for
six hours prior to surgery.
Condition:
Pain, Postoperative
Treatment:
Saline Solution
Start Date:
February 1, 2017
Sponsor:
Centre de Maternité de Monastir
For More Information:
https://clinicaltrials.gov/show/NCT03458078