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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol spinal acceptance | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure. | percent | 30 minutes preoperative. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The patient satisfaction regards the spinal anesthesia decision. | The patients express thier satisfaction with the spinal decision on a visual analogue score, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level. | 30 minutes at recovery room. |
| The total utilized dose of propofol. |
Inclusion Criteria:
Exclusion Criteria:
patients scheduled for an elective cesarean section.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delta Hospital | Al Mansurah | Dakahlya | 35516 | Egypt | ||
| Mansoura University Hospital |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
| 30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room. |
milligram |
| 1 minute after completion of spinal procedure, and 5 minutes at the end of cesarean section. |
| The rate of premature termination of spinal procedure (failure rate). | percent | 20 minutes preoperative. |
| The sedation score. | using modified Ramsay scale, 1. Anxious, 2. Cooperative, oriented, tranquil. 3. Responsive to commands only. If Asleep. 4. Brisk response to light glabellar tap or loud auditory stimulus. 5. Sluggish response to light glabellar tap or loud auditory stimulus. | determined 1 minutes after following spinal injection. then again after 10 minutes. |
| The infant Apgar score. | A measure of the physical condition of a newborn infant. Adding points (2, 1, or 0) for heart rate, respiratory effort, muscle tone, response to stimulation, and skin coloration; ranges from 0- 10, score of ten represents the best possible condition. | 0 and 5 minutes after delivery. |
| Patient's choice of anesthesia next time. | spinal or general anesthesia. | 30 minutes after shifting the patient to recovery room. |
| The incidence of desaturation during propofol spinal procedural sedation. | in percent, desaturation defined as oxygen saturation less than 90% | 20 minutes preoperative. |
| The incidence of hypotension during propofol spinal procedural sedation. | in percent, hypotension defined as mean blood pressure less than 60 millimeter mercury. | 20 minutes preoperative. |
| Al Mansurah |
| Dakahlya |
| 35516 |
| Egypt |
| Zagazig University Hospital | Zagazig | Sharkya | 44519 | Egypt |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |