Status:
COMPLETED
Analgesic Efficacy of Two Adjuvants During Spinal Anaesthesia.
Lead Sponsor:
Centre de Maternité de Monastir
Conditions:
Pain, Postoperative
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
: Pain modulation is very important after operation, particularly for women who undergo caesarean section. A pain-free postoperative period is essential following a caesarean section so new mothers ma...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03458078
Start Date
February 1 2017
End Date
June 30 2017
Last Update
March 8 2018
Active Locations (2)
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1
Chu Tahar Sfar
Mahdia, Tunisia, 5100
2
Centre de Maternité de Monastir
Monastir, Tunisia, 5000