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Dexmedetomidine Infusion and Surgical Pleth Index In Pediatrics

NCT05727969 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-02-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine at a a rate of 0.5 μg/kg/hour will be infused with induction of anesthesia.

DRUG

Lactated Ringer

Lactated ringer solution at a a rate of 0.5 μg/kg/hour will be infused with induction of anesthesia.

PROCEDURE

Hypospadias

Children who will undergone hypospadias surgery

DEVICE

Surgical pleth index

The SPI value will be measured using Datex-Ohmeda (GE Healthcare,Madison,WI 53707-7550 USA) monitoring system.

Sponsors & Collaborators

  • Fayoum University Hospital

    lead OTHER

Principal Investigators

  • Safaa G Megahed, MD · Fayoum University

  • Omar S Mahmoud, MD · Fayoum University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2023-11-15
Completion
2023-12-15

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05727969 on ClinicalTrials.gov