Clinical trial NCT03437980: Propofol Spinal Procedural Sedation for Cesarean Section
Official title: Can Propofol Procedural Sedation Implementation Increase the Acceptance of Spinal Anesthesia During Cesarean Section?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure.
timeFrame: 30 minutes preoperative.
Secondary outcomes:
measure: The rate of initial acceptance of spinal anesthesia without sedation.
timeFrame: 30 minutes preoperative.
measure: The anxiety score.
timeFrame: 30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room.
Other outcomes:
measure: The patient satisfaction regards the spinal anesthesia decision.
timeFrame: 30 minutes at recovery room.
measure: The total utilized dose of propofol.
timeFrame: 1 minute after completion of spinal procedure, and 5 minutes at the end of cesarean section.
measure: The rate of premature termination of spinal procedure (failure rate).
timeFrame: 20 minutes preoperative.
measure: The sedation score.
timeFrame: determined 1 minutes after following spinal injection. then again after 10 minutes.
measure: The infant Apgar score.
timeFrame: 0 and 5 minutes after delivery.
measure: Patient's choice of anesthesia next time.
timeFrame: 30 minutes after shifting the patient to recovery room.
measure: The incidence of desaturation during propofol spinal procedural sedation.
timeFrame: 20 minutes preoperative.
measure: The incidence of hypotension during propofol spinal procedural sedation.
timeFrame: 20 minutes preoperative.
Locations:
city: Mansourah
country: Egypt
facility: Delta Hospital
state: Dakahlya
city: Mansourah
country: Egypt
facility: Mansoura University Hospital
state: Dakahlya
city: Zagazig
country: Egypt
facility: Zagazig University Hospital
state: Sharkya
Study officials:
References: