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Clinical Trials/NCT03437980
NCT03437980
Completed
Not Applicable

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

Mansoura University3 sites in 1 country228 target enrollmentApril 1, 2018
Interventionspropofol

Overview

Phase
Not Applicable
Intervention
propofol
Conditions
Patient Compliance
Sponsor
Mansoura University
Enrollment
228
Locations
3
Primary Endpoint
The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure.
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
September 10, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alaa Mazy Mazy

associate professor of anesthesia and surgical intensive care

Mansoura University

Eligibility Criteria

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%,

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.

Arms & Interventions

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.

Intervention: propofol

Outcomes

Primary Outcomes

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

Time Frame: 30 minutes preoperative.

percent

Secondary Outcomes

  • The rate of initial acceptance of spinal anesthesia without sedation.(30 minutes preoperative.)
  • The anxiety score.(30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room.)

Study Sites (3)

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