Clinical trial NCT04614220: The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Caesarean Section
Official title: The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Cesarean Section of Primigravida: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acceptability of Health Care
Keywords: Caesarean Section
Regional anaesthesia
Consent
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 110
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 110 primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS •

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 in obstetric surgery. Already a high level of anxiety is present in obstetric patients preoperatively.

Detailed description: Hospital anxiety is commonly encountered, and it is reported to be seen in 60%-80% of patients who undergo surgery. There are many causes of preoperative anxiety including fear of death due to anesthesia or surgical procedure and fear of preoperative or postoperative pain.

Preoperative anxiety varies according to the patient's age, gender, educational status, history of previous operations, and medical status as well as the type of surgery and type of anesthesia. 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 in obstetric surgery. Already a high level of anxiety is present in obstetric patients preoperatively.

The anxious patients tend to prefer general anesthesia (GA) for cesarean section (CS). The patient refusal is the main contraindication for applying spinal anesthesia (SA) during CS. The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods including preoperative visit, information, and music, listening to Holy Quran recitation, hypnosis, nitrous oxide, and benzodiazepines. Intravenous sedation can control the anxiety in 90% of patients subjected to spinal procedures. While the evidence supports the benefits of procedural sedation for distressed, anxious pregnant women.

Eligibility criteria: Inclusion Criteria:

* primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS •

Exclusion criteria:

High risk pregnancy eg: pre eclampsia Absolute contra indiction for SA eg: severe anaemia Emergent CS. Patients with previous exposure to anaesthesia ( spinal or general ). Patients with educational level more than high school.

Primary outcomes:
measure: Acceptance rate to spinal anaethesia during CS
timeFrame: Preoperative .
measure: Anxiety score by the visual analogue score (VAS).
timeFrame: Preoperative
measure: Satisfaction rating scale
timeFrame: 6 hours Postoperative
Secondary outcomes:
measure: AGE
timeFrame: Preoperative
measure: heart rate (beat/min)
timeFrame: Preoperative
measure: Mean arterial blood pressure MAP (mmHg)
timeFrame: Preoperative
measure: peripheral oxygen saturation (Spo2)
timeFrame: Preoperative
measure: WEIGHT
timeFrame: Preoperative
measure: Height
timeFrame: Preoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine.Beni-suef university
Study officials:
affiliation: Faculty of medicine.Beni-suef university
name: Amira F Elgamel, Lecturer
role: STUDY_DIRECTOR
References: