Propofol Spinal Procedural Sedation for Cesarean Section

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can Propofol Procedural Sedation Implementation Increase the Acceptance of Spinal Anesthesia During Cesarean Section?

Conditions
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Patient Compliance

Intervention / Treatment
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* Drug: propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol spinal acceptance<br>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. | Drug: propofol<br>* A bolus of 0.7 mg/kg will be given initially, additional incremental doses of 20 mg propofol will be given if the patient complained of pain or moved arms towards the back. Patients will be sitting on the middle of the operating table facing towards the table's foot. The table's foot will be dropped 45 degrees for a comfortable chair position, Monitoring through pulse oximeter (SaO2), non-invasive blood pressure (NIBP) adjusted every 2 minutes automatic measuring and capnography tube in contact with nostrils.<br>* Other names: propofol procedural sedation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure. | percent | 30 minutes preoperative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of initial acceptance of spinal anesthesia without sedation. | percent | 30 minutes preoperative. | 
| The anxiety score. | by the visual analogue score from 0-10, where 10 is the maximum anxiety level. | 30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room. |