The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Caesarean Section

Completed

• Conditions: Acceptability of Health Care

• Registration Number: NCT04614220
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Study Start: 2021-03-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety score by the visual analogue score (VAS).	Preoperative	the visual analog score (VAS) from 0- 10, where 10 is the maximum anxiety level
Acceptance rate to spinal anaethesia during CS	Preoperative .	Questionnaire : The first decision for anesthesia, either spinal or general, will be recorded.; Then, patients who refuse SA and prefer general anesthesia (GA) will be consulted again as regards SA with presence of close relative for comfortable spinal procedure. Their last choice is the second decision that determines the final type of anesthesia to be implemented.
Satisfaction rating scale	6 hours Postoperative	Scale ( 1 - 10 ); 1is the lowest satisfaction 10 is the best satisfaction

Secondary Outcome Measures

Name	Time	Method
AGE	Preoperative	age per years
Height	Preoperative	Height per centimeter
Mean arterial blood pressure MAP (mmHg)	Preoperative	Mean arterial blood pressure MAP (mmHg)
WEIGHT	Preoperative	weight per kilograms
heart rate (beat/min)	Preoperative	heart rate (beat/min)
peripheral oxygen saturation (Spo2)	Preoperative	peripheral oxygen saturation (Spo2)

Trial Locations

Locations (1)

Faculty of medicine.Beni-suef university; 🇪🇬 Cairo, Egypt