Health Condition 1: - Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Paedfusor group: Paedfusor Model will be used for Total intravenous anesthesia (TIVA) with Propofol using TCI (target controlled infusion pump).
Study parameters will be documented for
Sponsors
Dr Raylene Dias
Eligibility
Inclusion criteria
Inclusion criteria: All pediatric patients from age 3 to 12 years of age belonging to ASA I and II undergoing elective laparoscopic abdominal and urogenital surgery under general anesthesia with endotracheal intubation
Exclusion criteria
Exclusion criteria: Expected duration of surgery more than 4 hours Expected blood loss more than 15 percent of blood volume History of allergy to Propofol or any other adjunct drug Patients with significant cardiovascular, hepatic or renal impairment Refusal of parental consent Inborn error of lipid metabolism Lack of cooperation during IV insertion necessitating IV insertion under inhalational agents as per institutional practices weight less than 5 kg or greater than 61 kg patients with sepsis or very sick children hemodynamic instability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare time to induction between the two modelsTimepoint: at induction of anesthesia | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare time to recovery after stopping infusion, defined as time from stopping infusion till eye openingTimepoint: patient will be observed till the time patient is in post anesthesia recovery area;To compare volume of Propofol consumedTimepoint: at the end of surgery when the infusion is switched off;To compare intraoperative hemodynamic parametersTimepoint: every 30 mins throughout the duration of anesthesia;To compare adverse events (hypotension bradycardia bronchospasm) intraoperativelyTimepoint: throughout the duration of surgery & anesthesia;To compare recovery characteristics & post operative adverse eventsTimepoint: till the time patient is in post anesthesia recovery area;To compare difference in the incidence of unwanted events during anesthesia: Lightening of anesthesia event (LAE)/deepening of anesthesia event (DAE)/unwanted spontanaous responsiveness event, defined as any involuntary movement (ie, movement of extremities) or somatic reaction ( ie, coughing, chewing, grimacing, breathing against the ventilator) in combination with a significant hemodynamic response during anesthesia maintenanceTimepoint: throughout the duration of surgery while the patient is under anesthesia;Number of time target plasma concentration (Cpt) needs to be reduced to less than 4 mcg per ml or increased to greater than 6 mcg per ml to maintain BIS between 40 to 60Timepoint: observed throughout the duration of surgery under anesthesia & to be documented every 30 mins as per the case record format | — |
Countries
India
Contacts
Public ContactDr Raylene Dias
Seth GS Medical College and KEM Hospital
Outcome results
None listed