Clinical trial

Effect Of Dexmedetomidine Infusion On Surgical Pleth Index In Pediatrics Undergoing Hypospadias Repair; A Prospective Observational Study

Name
M637
Description
This non-invasive dimensionless score index -SPI-reflects the Patients' sympathetic response to surgical stimulation. Its effectiveness in detecting the balance between nociceptor activation and analgesia was not only reported but also, was reported to be superior to the other parameters like blood pressure and heart rate. SPI value is correlated to pain and ranges from 0 to 100, higher values indicate strong surgical stimulus. Its value is obtained from photoplethysmographic amplitude (PPGA) and heart rate (HR) data from pulse oximetry measurement. Prediction of the severity of postoperative pain using SPI in both adults and children has been reported by several studies. So, the authors hypothesize that dexmedetomidine infusion without giving a bolus dose may affect the SPI in pediatrics undergoing hypospadias repair.
Trial arms
Trial start
2023-01-15
Estimated PCD
2023-11-15
Trial end
2023-12-15
Status
Completed
Treatment
Dexmedetomidine
Dexmedetomidine at a a rate of 0.5 μg/kg/hour will be infused with induction of anesthesia.
Arms:
Dexmedetomidine group
Other names:
Precedex
Lactated Ringer
Lactated ringer solution at a a rate of 0.5 μg/kg/hour will be infused with induction of anesthesia.
Arms:
Control group
Other names:
Solution
Hypospadias
Children who will undergone hypospadias surgery
Arms:
Control group, Dexmedetomidine group
Other names:
pediatric manuvere
Surgical pleth index
The SPI value will be measured using Datex-Ohmeda (GE Healthcare,Madison,WI 53707-7550 USA) monitoring system.
Arms:
Control group, Dexmedetomidine group
Other names:
SPI
Size
90
Primary endpoint
Surgical pleth index number
1 minute at end of the operation after skin closure.
Eligibility criteria
Inclusion Criteria: * Age 1-7years. * ASA physical status I-II. * Hypospadias surgery. Exclusion Criteria: * Children having a history of mental retardation. * Developmental delay. * Allergic to dexmedetomedine. * Neuraxial anesthesia. * Cardiovascular disease.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The randomization will be computer generated random number and the randomization sequence will be kept hidden in sealed opaque envelopes just opened after recruitment and admittance to the operating room.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "The group's allocations will be only blinded to assessors, data collectors, and parents of children", 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2024-02-22

1 organization

2 products

2 indications

Indication
Pain
Indication
Hypospadias