Dexmedetomidine Infusion and Surgical Pleth Index In Pediatrics

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hypospadias
• Intervention / Treatment: Drug: Lactated Ringer; Procedure: Hypospadias; Device: Surgical pleth index; Drug: Dexmedetomidine

Detailed Description

After obtaining Fayoum University's ethical committee permission and as well as the informed consent from the parents, 90 patients aged 1 to 7 years old scheduled for hypospadias repair will be randomly assigned into 2 groups.

Preoperative Assessment:

All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications.

Perioperative Management:

Patients will receive no premedication. After entering the Operating room, All patients will be monitored using surgical pleth index, arterial blood pressure, pulse oximetry, and electrocardiography. The SPI value will be measured using Datex-Ohmeda (GE Healthcare,Madison,WI 53707-7550 USA) monitoring system.

Inhalational induction of general anesthesia (GA) will be performed with a face mask using sevoflurane 8% and 50% oxygen in the air, and then an intravenous (IV) cannula will be inserted.

Fentanyl will be administered intravenously at 1 μg/kg, atracurium 0.5 mg/kg and an endotracheal tube will be used to secure the airway.

Anesthesia will be maintained with 1% isoflurane, 50% oxygen in the air, and atracurium infusion (0.10 mg/kg).

During the operation, bradycardia is defined as a 30% decrease from the baseline HR, and hypotension is defined as a 30% decrease from the baseline MAP. In these cases, 0.01 mg/kg of atropine and 0.1 mg/kg of ephedrine, respectively, will be given intravenously. Additionally, tachycardia is defined as a 30% increase from the baseline HR, and hypertension is defined as a 30% increase from the baseline MAP. If either of these occurred, 0.1 μg/kg of fentanyl was given intravenously, and then the incidence was calculated and analyzed.

At the end of the surgery, acetaminophen 15 mg/kg IV will be administered to all patients. After completion of the surgical procedure and emergence from anesthesia, the patient will be referred to PACU. Quality of analgesia will be assessed using a face, legs, activity, cry, consolability (FLACC scale) at PACU discharge and 2, 4, 6, 12, and 24 hours postoperatively. Diclofenac sodium 1 mg/kg rectally will be given as rescue analgesia for patients in all study groups in PACU if the FLACC scale > 4. Nurses will be informed about the pain evaluation, to give the patients oral paracetamol 30 mg/kg. The data collectors from nurses will record data. The depth of sedation will be assessed using Ramsy sedation score (RSS) at PACU discharge and 2 hours postoperative by the investigators.

The patient will be discharged from PACU using The Modified Aldrete Score system after an assessment of the patient's activity, respiration, blood pressure, consciousness, and color, A score ≥ 9 is required for discharge from the PACU.

Adverse events like bradycardia hypotension excessive sedation respiratory depression postoperative agitation nausea and vomiting will be recorded during the first 24 hours.

Statistical analysis

• Sample size calculation was done using IBM SPSS version 29 for Windows. A total of 45 children per group are needed to be able to detect an expected difference in the SPI based on previous research.This sample size was estimated using a power of 80% and alpha of 0.05.
• Descriptive statistics for the variables will be presented in the form of mean with standard deviation or median with interquartile range for numeric variables, while frequencies and percentages will be used for categorical variables. Comparison of the two groups will be done after testing for normality of the distribution using Shapiro-wilk test. The analysis will be done using the independent samples t test or using the non-parametric Mann Whitney test for numerical variables. Categorical variables will be compared using Chi Square test or Fisher's exact test. IBM SPSS version 28 for Windows software will be used for the analysis. A p-value of < 0.05 will be considered statistically significant.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed A Hamed, MD; Phone Number: +2 01010509736; Email: mah07@fayoum.edu.eg
• Study Contact Backup: Name: Emad M Abdelfatah, MBBCh; Phone Number: +2 01094006418; Email: omado.hos@gmail.com

Study Locations

• Egypt
  • Faiyum Governorate
    • Madīnat al Fayyūm, Faiyum Governorate, Egypt, 63514
      • Fayoum University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; The control group, lactated ringer solution will be infused.	Drug: Lactated Ringer; Lactated ringer solution at a a rate of 0.5 μg/kg/hour will be infused with induction of anesthesia.; Other Names: Solution; Procedure: Hypospadias; Children who will undergone hypospadias surgery; Other Names: pediatric manuvere; Device: Surgical pleth index; The SPI value will be measured using Datex-Ohmeda (GE Healthcare,Madison,WI 53707-7550 USA) monitoring system.; Other Names: SPI
Experimental: Dexmedetomidine group; In the dexmedetomidine group, dexmedetomidine will be infused.	Procedure: Hypospadias; Children who will undergone hypospadias surgery; Other Names: pediatric manuvere; Device: Surgical pleth index; The SPI value will be measured using Datex-Ohmeda (GE Healthcare,Madison,WI 53707-7550 USA) monitoring system.; Other Names: SPI; Drug: Dexmedetomidine; Dexmedetomidine at a a rate of 0.5 μg/kg/hour will be infused with induction of anesthesia.; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical pleth index number	from 0 to 100, higher values indicate strong surgical stimulus	1 minute before induction of anesthesia.
Surgical pleth index number	from 0 to 100, higher values indicate strong surgical stimulus	1 minute after insertion of endotracheal tube.
Surgical pleth index number	from 0 to 100, higher values indicate strong surgical stimulus	1 minute after beginning of surgery with skin incision.
Surgical pleth index number	from 0 to 100, higher values indicate strong surgical stimulus	5 minutes after recovery at post anesthesia care unit.
Mean arterial blood pressure	in mmHg	5 minutes after recovery at post anesthesia care unit.
Mean arterial blood pressure	in mmHg	1 minute before induction of anesthesia.
Mean arterial blood pressure	in mmHg	1 minute after beginning of surgery with skin incision.
Heart rate	beat/minute	1 minute after beginning of surgery with skin incision.
Heart rate	beat/minute	1 minute before induction of anesthesia.
Heart rate	beat/minute	5 minutes after recovery at post anesthesia care unit.
Heart rate	beat/minute	1 minute at end of the operation after skin closure.
Mean arterial blood pressure	mmHg	1 minute at end of the operation after skin closure.
Need of vasoactive drugs	Yes or no	1minute after infusion until end of surgery
FLACC pain score	F:face - L:legs - A:activity - C:cry - C:consolability for description of pain degree in children	5 minutes after recovery in postanesthesia care unit
FLACC pain score	F:face - L:legs - A:activity - C:cry - C:consolability for description of pain degree in children	2 hours after recovery in postanesthesia care unit
Ramsay sedation score	0:5 with 0:deeply sedation to 5:no sedation	5 minutes after recovery in postanesthesia care unit
Ramsay sedation score	0:5 with 0:deeply sedation to 5:no sedation	2 hours after recovery in postanesthesia care unit
FLACC pain score	F:face - L:legs - A:activity - C:cry - C:consolability for description of pain degree in children	4 hours after discharge from recovery
FLACC pain score	F:face - L:legs - A:activity - C:cry - C:consolability for description of pain degree in children	6 hours after discharge from recovery
FLACC pain score	F:face - L:legs - A:activity - C:cry - C:consolability for description of pain degree in children	12 hours after discharge from recovery
FLACC pain score	F:face - L:legs - A:activity - C:cry - C:consolability for description of pain degree in children	24 hours after discharge from recovery
Surgical time	from when the surgeon of record starts the procedure until complete skin closure in minutes	1 minute after skin
Anesthesia time	from the start of anesthesia to the end of an anesthesia service in minutes	5 minutes after insertion of endotracheal tube
Total opioid consumption	in milligram	24 hours after operation
Time of 1st analgesia dose	time when first analgesic drug is injected for pain (in hours)	24 hours postoperatively
Total non-steroidal consumption	time when first usage of non-steroidal anti-inflammatory drug is injected for pain (in hours)	24 hours postoperatively
Extubation time	time from the end of surgery to airway extubation (in minutes)	2 minutes after removal of endotracheal tube

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	in years	1 hour preoperatively
American society of anesthesiology classification	Either I: normal healthy or II: mild systemic disease	1 hour preoperatively

Collaborators and Investigators

• Sponsor: Fayoum University Hospital
• Investigators: Study Director: Safaa G Megahed, MD, Fayoum university; Study Director: Omar S Mahmoud, MD, Fayoum university

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Postoperative analgesia; Hypospadias; Surgical pleth index
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypospadias; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: M637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No