Propofol Spinal Procedural Sedation for Cesarean Section

Mansoura University228 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

228

Conditions

Patient Compliance

Interventions

propofolDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (3)

Delta Hospital

Al Mansurah, Dakahlya, Egypt

Mansoura University Hospital

Al Mansurah, Dakahlya, Egypt

Zagazig University Hospital

Zagazig, Sharkya, Egypt

Outcomes

Primary Outcomes

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

percent

Time frame: 30 minutes preoperative.

Secondary Outcomes

The rate of initial acceptance of spinal anesthesia without sedation.

percent

Time frame: 30 minutes preoperative.

The anxiety score.

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

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

Data from ClinicalTrials.gov

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