Propofol Spinal Procedural Sedation for Cesarean Section
- Registration Number
- NCT03437980
- Lead Sponsor
- Mansoura University
- Brief Summary
Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence, guidelines and quality markers, regional anesthesia is preferred over general anesthesia in obstetric surgery. A high level of anxiety is present in obstetric patients preoperatively. Patients with high anxiety tend to prefer general anesthesia for cesarean section. The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods. The evidence supports the benefits of procedural sedation for distressed, anxious pregnant women.
- Detailed Description
Propofol provides short onset, rapid predictable action, anxiolysis and amnesia and it is more effective than benzodiazepines. Using propofol infusion in low doses during spinal injection in CS did not adversely affect the Apgar scores or the neurological and adaptive fetal outcomes. The general consensus is that procedural sedation is not a routine for spinal interventions, but required for anxious patients. Our hypothesis is that, with the high prevalence of maternal anxiety during cesarean section, ensuring painless comfortable spinal anesthesia may increase the acceptance rate of regional anesthesia during cesarean section.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 228
- Patients scheduled for elective cesarean section,
- Age: 18 - 40 years,
- American Society of Anesthesiologists I - III,
- Patients may present any of the following conditions:
- Respiratory diseases as bronchial asthma
- Hepatic compromise,
- Preeclampsia,
- Anemia with hemoglobin 10 g/dl,
- Previous sections,
- Obese with BMI more than 35%,
- Any criteria of difficult intubation, Compromised fetus as premature delivery, History of complications or non-satisfaction after general anesthesia during previous cesarean section,
- Patients refusing to participate in the study,
- Known psychiatric disease,
- Addiction medications,
- Communication barrier,
- Absolute or relative contraindication for spinal anesthesia,
- Bad obstetric history, complicated pregnancy, congenital fetal anomaly.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description propofol spinal acceptance propofol The surgeon and the anesthetist will discuss the exclusion criteria. Then they will discuss the information's about spinal and general anesthesia with the illegible patients, also reply the patient's questions in a preoperative visit. The primary decision for the patient; either spinal or general anesthesia will be recorded. The patients refusing spinal anesthesia will be discussed again to detect the rate of acceptance of spinal anesthesia if propofol sedation is ensured during the procedure to provide a painless spinal injection. The final decision will be applied; either spinal with procedural sedation, or general anesthesia.
- Primary Outcome Measures
Name Time Method The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure. 30 minutes preoperative. percent
- Secondary Outcome Measures
Name Time Method The rate of initial acceptance of spinal anesthesia without sedation. 30 minutes preoperative. percent
The anxiety score. 30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room. by the visual analogue score from 0-10, where 10 is the maximum anxiety level.
Trial Locations
- Locations (3)
Delta Hospital
🇪🇬Mansourah, Dakahlya, Egypt
Mansoura University Hospital
🇪🇬Mansourah, Dakahlya, Egypt
Zagazig University Hospital
🇪🇬Zagazig, Sharkya, Egypt