Analgesic Efficacy of Two Adjuvants During Spinal Anaesthesia.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03458078
• Date of registration: 15/02/2018
• Prospective Registration: No
• Primary sponsor: Centre de Maternité de Monastir
• Public title: Analgesic Efficacy of Two Adjuvants During Spinal Anaesthesia.
• Scientific title: Comparison of the Analgesic Efficacy of Two Adjuvants to Hyperbaric Bupivacaine During Spinal Anaesthesia for Caesarean Section.
• Date of first enrolment: February 1, 2017
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03458078
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 2/Phase 3

Countries of recruitment

Tunisia

Contacts

• Name: Rim Cherif, Dr.
• Affiliation: CHU TAHAR SFAR MAHDIA

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Pain, Postoperative

Intervention(s)

Drug: Magnesium Sulfate

Drug: Midazolam 5 MG/ML Injection

Drug: Saline Solution

Primary Outcome(s)

The first requirement for analgesic [Time Frame: 24 hours postoperative]

Secondary Outcome(s)

The sensory blocks [Time Frame: 24 hours postoperative]

Sedation Score [Time Frame: 24 hours post operative]

Maternal satisfaction [Time Frame: 24 hours post operative]

Hypotension [Time Frame: 24 hours post operative]

Bradycardia [Time Frame: 24 hours post operative]

The motor block [Time Frame: 24 hours postoperative]

Secondary ID(s)

CMMonastir

Source(s) of Monetary Support

Please refer to primary and secondary sponsors