Propofol Spinal Procedural Sedation for Cesarean Section

Patient Compliance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437980
• Other study ID #: R.18.02.23
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: September 10, 2018

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: September 10, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patient Compliance

Intervention

Drug:
• propofol
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.

Locations

Country	Name	City	State
Egypt	Delta Hospital	Mansourah	Dakahlya
Egypt	Mansoura University Hospital	Mansourah	Dakahlya
Egypt	Zagazig University Hospital	Zagazig	Sharkya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	The total utilized dose of propofol.	milligram	1 minute after completion of spinal procedure, and 5 minutes at the end of cesarean section.
Other	The rate of premature termination of spinal procedure (failure rate).	percent	20 minutes preoperative.
Other	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.
Other	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.
Other	Patient's choice of anesthesia next time.	spinal or general anesthesia.	30 minutes after shifting the patient to recovery room.
Other	The incidence of desaturation during propofol spinal procedural sedation.	in percent, desaturation defined as oxygen saturation less than 90%	20 minutes preoperative.
Other	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.
Primary	The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure.	percent	30 minutes preoperative.
Secondary	The rate of initial acceptance of spinal anesthesia without sedation.	percent	30 minutes preoperative.
Secondary	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.