HOW DOES PREOPERATIVE RISK FACTORS AFFECT THE POSTOPERATIVE OUTCOME IN NEONATES UNDERGOING ABDOMINAL SURGERY UNDER GENERAL ANAESTHESIA

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2020/01/022931

Lead Sponsor: LADY HARDINGE MEDICAL COLLEGE

Brief Summary: With advances in anaesthesia and surgical skills in paediatrics,there has been a great improvement in surgical outcome of children undergoing surgery under general anaesthesia in the last half century.Even though there has been improvement in surgical skills,understanding of neonatal physiology,anatomy,biochemistry and drug pharmacology,adverse outcomes still continue to occur in the special subgroup of paediatric anaesthesia i.e neonates ( under 30 days of birth ).They have higher risk because of immature and sensitive vital body systems including respiratory, cardiovascular, renal, hepatobiliary, nervous and neuromuscular system. It is well established that for a better postoperative outcome 60weeks post conceptual age for elective and 44weeks postconceptual age for emergency surgeries; is a better time. Thus any surgery taken before 44 weeks of postconceptual age has an extremely high risk, which is further increased by additional factors in the preoperative period and may adversely affect the outcome, such as low birth weight, gestational age, respiratory distress, hypotension, tachycardia, congenital anomalies, surgical site, duration of surger and many other factors.

This study aims to find correlation between preoperative risk factors with extubation time in neonates undergoing abdominal surgery under general anaesthesia. Most of the articles have studied postoperative outcome in terms of death and survival only and most of them are retrospective studies only. There was no article correlating preoperative risk factors with postoperative outcome in terms of extubation in <48hrs or >48hrs in neonates undergoing abdominal surgery under general anaesthesia.

This study is a prospective observational study which wil be conducted in lady hardinge medical college and kalawati hospital taking atleat 50 cases of neonates (i.e upto 28days of birth) undergoing abdominal surgery under general anaesthesia.All patients will undergo a detailed pre anaesthetic evaluation. A written informed consent will be taken from parents of all patients.

During surgery, GA will be given as per the standard protocol with intubation and controlled ventilation. All patients will be provided with high standard of care and monitoring in perioperative period. At the end of surgery, all neonates will be shifted to postoperative ward for further care and monitoring. We will follow up the patient until final outcome (death / survival)

Following observation will be made and noted

PREOPERATIVE: birth weight, gestational age (GA), delivery details, congenital anomalies, surgical diagnosis and surgery proposed, laboratory parameters (CBC, LFT, KFT, ABG), vasopressors support, respiratory support.

INTRAOPERATIVE: total doses of anaesthesia drugs used, duration of anaesthesia (Anesthesia Time - time from which neonate is brought to Operation table and wheeled out) & surgery (Skin incision to skin closure), surgical procedure performed, haemodynamic events (tachycardia /bradycardia /hypotension/ hypertension) requiring intervention, respiratory events (repeated desaturation), failure to extubate, blood transfusion.

POSTOPERATIVE: vasopressors / respiratory support, laboratory parameters, urine output, time of extubation, day of discharge/death

Data will be analyzed clinically and statistically and will be recorded in a proforma

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Neonates i .e upto 28 days of birth 2.
Intra-abdominal surgeries 3.

Exclusion Criteria

Inguinal hernia and paraumbilical hernia 2.
Procedures done under local anaesthesia (LA) 3.
Laparoscopic surgeries.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of preoperative risk factors (birth weight, gestational age, presence of congenital anomalies, hemodynamic and respiratory support) contributing to postoperative outcome (Extubation within 48hrs or more) in neonates undergoing abdominal surgery under GA.	Proportion of preoperative risk factors (birth weight, gestational age, presence of congenital anomalies, hemodynamic and respiratory support) contributing to postoperative outcome (Extubation within 48hrs or more) in neonates undergoing abdominal surgery under GA.

Secondary Outcome Measures

Name	Time	Method
Proportion of neonates extubated within 48hrs of abdominal surgery under GA in relation to	1.mean duration of anaesthesia.

Trial Locations

Locations (1): LADY HARDINGE MEDICAL COLLEGE AND KALAWATI SARAN CHILDRENS HOSPITAL
🇮🇳
Central, DELHI, India
LADY HARDINGE MEDICAL COLLEGE AND KALAWATI SARAN CHILDRENS HOSPITAL
🇮🇳Central, DELHI, India
DR USHA SAHA
Principal investigator
9810982588
usha_shivsaha@yahoo.com