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Completed

NCT Number: NCT03437980

Propofol Spinal Procedural Sedation for 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.

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Key information

Conditions

Patient Compliance Behavior Health Behavior Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Delta Hospital, Al Mansurah, Dakahlya, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: propofol procedural sedation

Primary outcomes

  1. The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure.

    Time frame: 30 minutes preoperative.

    percent

Secondary outcomes

  1. The rate of initial acceptance of spinal anesthesia without sedation.

    Time frame: 30 minutes preoperative.

    percent

  2. The anxiety score.

    Time frame: 30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room.

    by the visual analogue score from 0-10, where 10 is the maximum anxiety level.

Other outcomes

  1. The patient satisfaction regards the spinal anesthesia decision.

    Time frame: 30 minutes at recovery room.

    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.

  2. The total utilized dose of propofol.

    Time frame: 1 minute after completion of spinal procedure, and 5 minutes at the end of cesarean section.

    milligram

  3. The rate of premature termination of spinal procedure (failure rate).

    Time frame: 20 minutes preoperative.

    percent

  4. The sedation score.

    Time frame: determined 1 minutes after following spinal injection. then again after 10 minutes.

    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.

  5. The infant Apgar score.

    Time frame: 0 and 5 minutes after delivery.

    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.

  6. Patient's choice of anesthesia next time.

    Time frame: 30 minutes after shifting the patient to recovery room.

    spinal or general anesthesia.

  7. The incidence of desaturation during propofol spinal procedural sedation.

    Time frame: 20 minutes preoperative.

    in percent, desaturation defined as oxygen saturation less than 90%

  8. The incidence of hypotension during propofol spinal procedural sedation.

    Time frame: 20 minutes preoperative.

    in percent, hypotension defined as mean blood pressure less than 60 millimeter mercury.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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