Clinical trial

Efficacy of Intrathecal Clonidine Versus Neostigmine as Adjuvants to Bupivacaine on Postoperative Maternal and Fetal Outcomes After Elective Cesarean Section: A Randomized Double Blind Controlled Trial

Name
Clonidine versus Neostigmine
Description
The delivery of the infant into the arms of a conscious and pain free mother is one of the most exciting and rewarding moments in medicine. Neuraxial anesthesia is now the preferred technique for lower segment cesarean sections (LSCS). Although epidural, spinal, continuous spinal, and combined spinal-epidural techniques have all been advocated, most cesarean sections are performed under single-shot spinal anesthesia. Even when a long acting local anesthetic like bupivacaine is used, the duration of spinal anesthesia (SA) is short and higher doses of analgesics are required in the postoperative period. Therefore, achieving a subarachnoid block that provides high quality postoperative analgesia of consistently prolonged duration is an attractive goal.
Trial arms
Trial start
2023-12-01
Estimated PCD
2025-09-30
Trial end
2025-11-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
Clonidine
compare the effect of intrathecal Clonidine and Neostigmine as adjuvants to Bupivacaine in elective cesarean section
Arms:
Group B, Group BC, Group BN
Size
111
Primary endpoint
postoperative analgesic efficacy of intrathecal clonidine and neostigmine by use of numerical rating scale (NRS) pain score.
2 hours after time of sensory block
Eligibility criteria
Inclusion Criteria: 1. Age: ranges from 20 - 35 years old. 2. ASA physical status II. 3. Singleton fetus at term. 4. Parturient scheduled for elective lower segment cesarian section under spinal anethesia Exclusion Criteria: 1. Patient refusal. 2. Contraindications to spinal blockade, such cardiorespiratory problems, coagulopathy, neurological disease, psychological troubles, and allergy to the used drugs. 3. Morbid obesity. 4. Failure of spinal blockade. 5. Emergency CS. 6. Complicated pregnancy. 7. Intrauterine fetal compromise.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 111, 'type': 'ESTIMATED'}}
Updated at
2023-07-13

1 organization

1 product

1 indication

Organization
Assiut University
Product
Clonidine