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Clinical Trials/CTRI/2024/07/070342
CTRI/2024/07/070342
Not yet recruiting
Not Applicable

Incidence of hypoactive emergence delirium in the paediatric population and its correlation with perioperative factors: A prospective, observational study

Hamdard Institute of Medical Sciences and Research1 site in 1 country145 target enrollmentStarted: July 22, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Hamdard Institute of Medical Sciences and Research
Enrollment
145
Locations
1
Primary Endpoint
To calculate the incidence of hypoactive emergence delirium (ED) by finding the

Overview

Brief Summary

This study is a prospective, observational study, to determine the incidence of hypoactive delirium in paediatric surgical patients in our hospital and correlate it with anaesthesia factors, surgical factors and patient factors. The incidence of hypoactive delirium will be found by calculating the additional yield of CAPD scale over PAED scale. The objectives of the study are-

  1. To calculate the incidence of hypoactive emergence delirium by finding the additional yield of CAPD score over PAED score in paediatric patients

2)To study the correlation between hypoactive ED and anaesthesia technique. 3)To study the correlation between hypoactive ED and patients factors (age, gender, pre-operative anxiety, preoperative fasting, postoperative pain). 4)To study the correlation between hypoactive ED and surgical factors (type of surgery, duration of surgery).

The trial is conducted in a single centre in the operation theatres of Hamdard Institute of Medical Sciences and Research.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
0.00 Day(s) to 18.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All patients up to 18 years of age, with American Society of Anaesthesiologist (ASA) physical status I-II posted for surgery.

Exclusion Criteria

  • Patient or parent refusal
  • Patient planned for surgery exclusively under regional anesthesia
  • Patients with liver or renal insufficiency
  • Patients with any active systemic infection or disease
  • Patients with neurological or psychiatric disorders
  • Patients with prior opioid addiction
  • Patients with deafness, blindness or other sensory deficit 8.

Outcomes

Primary Outcomes

To calculate the incidence of hypoactive emergence delirium (ED) by finding the

Time Frame: Scores will be given at the completion of childs stay in post anesthesia care unit (PACU). The child will be discharged from PACU after 45 minutes of PACU stay or on achieving Modified Aldrete Score of 9 or more whichever is later

additional yield of CAP-D score over PAED score in pediatric patients.

Time Frame: Scores will be given at the completion of childs stay in post anesthesia care unit (PACU). The child will be discharged from PACU after 45 minutes of PACU stay or on achieving Modified Aldrete Score of 9 or more whichever is later

Secondary Outcomes

  • To calculate the incidence of hypoactive emergence delirium by finding the(additional yield of CAP-D score over PAED score in pediatric patients)

Investigators

Sponsor
Hamdard Institute of Medical Sciences and Research
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Asna Jamal

Hamdard Institute of Medical Sciences and Research

Study Sites (1)

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