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Clinical Trials/NCT04614220
NCT04614220
Completed
Not Applicable

The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Cesarean Section of Primigravida: A Prospective Observational Study

Beni-Suef University1 site in 1 country110 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acceptability of Health Care
Sponsor
Beni-Suef University
Enrollment
110
Locations
1
Primary Endpoint
Anxiety score by the visual analogue score (VAS).
Status
Completed
Last Updated
2 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 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
September 1, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Hussein Bahr

Lecturer in Department of Anaesthesia , surgical ICU and pain management (Faculty of medicine)

Beni-Suef University

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Anxiety score by the visual analogue score (VAS).

Time Frame: Preoperative

the visual analog score (VAS) from 0- 10, where 10 is the maximum anxiety level

Acceptance rate to spinal anaethesia during CS

Time Frame: 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

Time Frame: 6 hours Postoperative

Scale ( 1 - 10 ) 1is the lowest satisfaction 10 is the best satisfaction

Secondary Outcomes

  • AGE(Preoperative)
  • Height(Preoperative)
  • Mean arterial blood pressure MAP (mmHg)(Preoperative)
  • WEIGHT(Preoperative)
  • heart rate (beat/min)(Preoperative)
  • peripheral oxygen saturation (Spo2)(Preoperative)

Study Sites (1)

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