Comparison between different forms of anesthesia for surgeries in children

Not yet recruiting

Conditions: Unilateral inguinal hernia, without obstruction or gangrene,

Registration Number: CTRI/2020/10/028197

Brief Summary: Aim : To assess and evaluate the post-operative recovery characteristics in paediatric population arriving in PACU after infraumbilical superficial surgeries and to compare them in terms of the quality of anaesthetic technique used.

The objectives include to study the following among children undergoing infraumbilical superficial surgeries:

1.     Assess the post-operative recovery characteristics in PACU

2.     Evaluate these characteristics in terms of the type of anesthetic technique.

3.     Compare the cost aspects of regional anaesthesia alone with general anaesthesia & general with regional anaesthesia

The study will be conducted in Kasturba Medical College after obtaining clearance from departmental and institutional ethical committee following which the study will be enlisted in the Clinical Trial Registry of India. The study will be conducted over a period of two years from the date of approval. All patients with in the age group of 1-6 years who undergo infraumbilical superficial surgeries, duration of which is within 1 hour who are transferred to the PACU will be included in the study. Informed consent will be taken from the parents of the children. The anaesthesia PACU records of these patients will be accessed from the Medical Records Department, evaluated and data will be recorded. Children will be categorised based on the anaesthetic technique they underwent. Categories will be general anaesthesia, general anaesthesia with regional techniques, and regional anaesthesia alone. The following objective parameters will be obtained from anaesthesia records in Medical Records Department.

1.     Blood pressure

2.     Saturation(SPO2)

3.     Heart rate

4.     Level of sedation

5.     Peripheral body temperature

6.     Pain scores

7.     Post-operative vomiting

Besides these parameters, the following details also will be noted:

1.     Type of anaesthesia received

2.     Duration of surgery

3.     Rescue analgesia given in PACU

4.     Time to restart oral feeds

5.     Time to discharge from PACU

6.     Time interval from surgery to first voiding

7.     Residual weakness in regional techniques

8.     Anaesthesia expenses

All data will be collected in a pre-designed and pre-tested data extraction sheet by a dedicated postgraduate who is a trainee in department of anaesthesiology. Subsequently, data will be entered in Microsoft excel and exported to SPSS v 16.0 for further statistical analysis. All categorical variables will be expressed as frequencies and percentages and continuous variables in mean and Standard deviation. ANOVA test will be used to study the significance between the recovery characteristics and type of anaesthesia

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

ASA Grades 1 & 2 Elective infra-umbilical superficial surgeries Duration of surgery less than one hour.

Exclusion Criteria

Categories outside inclusion criteria Congenital anomalies Patients whose parents are not willing for the study.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess post-operative recovery characteristics in Post- Anaesthesia Care Unit	Immediate post-op, 6 hours after surgery and records from medical records department

Secondary Outcome Measures

Name	Time	Method
Evaluate the characteristics in terms of type of anaesthesia technique	Compare the cost aspects of regional anaesthesia alone with general and general with regional

Trial Locations

Locations (1): Kasturba Medical College
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College
🇮🇳Udupi, KARNATAKA, India
Dr Devika Anil
Principal investigator
9995176716
drdevikaanil@gmail.com