Dexmedetomidine Infusion and Surgical Pleth Index In Pediatrics

NCT05727969 | Completed

• 1 other identifier: M637
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Pain; Hypospadias

Keywords

Dexmedetomidine; Hypospadias; Postoperative analgesia; Surgical pleth index

Outcome Measures

Primary Outcomes (1)

• Surgical pleth index number

  from 0 to 100, higher values indicate strong surgical stimulus

  1 minute at end of the operation after skin closure.

Secondary Outcomes (27)

• Surgical pleth index number

  1 minute before induction of anesthesia.

• Surgical pleth index number

  1 minute after insertion of endotracheal tube.

• Surgical pleth index number

  1 minute after beginning of surgery with skin incision.

• Surgical pleth index number

  5 minutes after recovery at post anesthesia care unit.

• Mean arterial blood pressure

  5 minutes after recovery at post anesthesia care unit.

Other Outcomes (2)

• Age

  1 hour preoperatively

• American society of anesthesiology classification

  1 hour preoperatively

Study Arms (2)

Control group

PLACEBO COMPARATOR

The control group, lactated ringer solution will be infused.

Drug: Lactated Ringer; Procedure: Hypospadias; Device: Surgical pleth index

Dexmedetomidine group

EXPERIMENTAL

In the dexmedetomidine group, dexmedetomidine will be infused.

Drug: Dexmedetomidine; Procedure: Hypospadias; Device: Surgical pleth index

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine group

Lactated Ringer DRUG

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

Also known as: Solution

Control group

Hypospadias PROCEDURE

Children who will undergone hypospadias surgery

Also known as: pediatric manuvere

Control group; Dexmedetomidine group

Surgical pleth index DEVICE

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

Also known as: SPI

Control group; Dexmedetomidine group

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 1-7years.
• ASA physical status I-II.
• Hypospadias surgery.

You may not qualify if:

• Children having a history of mental retardation.
• Developmental delay.
• Allergic to dexmedetomedine.
• Neuraxial anesthesia.
• Cardiovascular disease.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (3)

• Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.

  PMID: 17329347 BACKGROUND

• Hamunen K, Kontinen V, Hakala E, Talke P, Paloheimo M, Kalso E. Effect of pain on autonomic nervous system indices derived from photoplethysmography in healthy volunteers. Br J Anaesth. 2012 May;108(5):838-44. doi: 10.1093/bja/aes001. Epub 2012 Feb 26.

  PMID: 22369767 BACKGROUND

• Constant I, Sabourdin N. Monitoring depth of anesthesia: from consciousness to nociception. A window on subcortical brain activity. Paediatr Anaesth. 2015 Jan;25(1):73-82. doi: 10.1111/pan.12586. Epub 2014 Nov 20.

  PMID: 25410376 BACKGROUND

MeSH Terms

Conditions

Pain; Hypospadias

Interventions

Dexmedetomidine; Ringer's Lactate; Solutions

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Pharmaceutical Preparations

Study Officials

• Safaa G Megahed, MD

  Fayoum University

  STUDY DIRECTOR

• Omar S Mahmoud, MD

  Fayoum University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group's allocations will be only blinded to assessors, data collectors, and parents of children
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 14, 2023
• Study Start: January 15, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)