Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727969
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2023-01-24
Brief Title:
Dexmedetomidine Infusion and Surgical Pleth Index In Pediatrics
Sponsor:
Fayoum University Hospital
Organization:
Fayoum University Hospital
Study Overview
Official Title:
Effect Of Dexmedetomidine Infusion On Surgical Pleth Index In Pediatrics Undergoing Hypospadias Repair A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
After obtaining Fayoum Universitys 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 HealthcareMadisonWI 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 μgkg atracurium 05 mgkg 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 010 mgkg
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 001 mgkg of atropine and 01 mgkg 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 01 μgkg of fentanyl was given intravenously and then the incidence was calculated and analyzed
At the end of the surgery acetaminophen 15 mgkg 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 mgkg 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 mgkg 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 patients 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 researchThis sample size was estimated using a power of 80 and alpha of 005
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 Fishers exact test IBM SPSS version 28 for Windows software will be used for the analysis A p-value of 005 will be considered statistically significant
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 HealthcareMadisonWI 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 μgkg atracurium 05 mgkg 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 010 mgkg
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 001 mgkg of atropine and 01 mgkg 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 01 μgkg of fentanyl was given intravenously and then the incidence was calculated and analyzed
At the end of the surgery acetaminophen 15 mgkg 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 mgkg 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 mgkg 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 patients 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 researchThis sample size was estimated using a power of 80 and alpha of 005
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 Fishers exact test IBM SPSS version 28 for Windows software will be used for the analysis A p-value of 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None