Propofol Spinal Procedural Sedation for Cesarean Section

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Compliance
• Intervention / Treatment: Drug: propofol

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.

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlya
    • Mansourah, Dakahlya, Egypt, 35516
      • Delta Hospital
    • Mansourah, Dakahlya, Egypt, 35516
      • Mansoura University Hospital
  • Sharkya
    • Zagazig, Sharkya, Egypt, 44519
      • Zagazig University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: propofol spinal acceptance; 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; 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.; Other Names: propofol procedural sedation

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): July 10, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: February 4, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: R.18.02.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No