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Recruiting NCT06846983

Peripheral Perfusion Index as an Early Predictor of Successful Caudal Block in Pediatric Patients Undergoing Lower Abdominopelvic Surgeries Under General Anesthesia

Observational Peripheral Perfusion Index Caudal Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peripheral perfusion index pulse oximeter.
Who it may be relevant to
Registry conditions: Peripheral Perfusion Index, Caudal Block. Basic parameters: 1 year — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The aim of this study is to assess early predictability of peripheral perfusion index to success of caudal block in pediatric patients undergoing lower abdominopelvic surgeries

Detailed description

The aim of this study is to assess early predictability of peripheral perfusion index to success of caudal block in pediatric patients undergoing lower abdominopelvic surgeries. Preoperative assessment will be done which includes full history taking, clinical examination, standard laboratory investigations. Demographic data (age, weight, and sex) will be recorded.

All patients will be instructed to fast for 6 hours preoperatively while allowing clear fluids up to 2 hours prior to anesthesia as per the standard nil per oral (NPO) guidelines.

In the operating room, all patients will be monitored during the operation using: electrocardiography (ECG), pulse oximeter (SpO2), automated non-invasive arterial pressure (NIAP) measurement cuff, end tidal carbon dioxide (capnogram), volatile anesthetic monitoring, core temperature monitoring using a nasopharyngeal probe, and Masimo pulse oximeter probe for measuring PPI which will be applied to the big toe of the patient's foot and wrapped with gauze to reduce heat loss and to avoid the interference of ambient light.

Normothermia will be maintained using warm intravenous fluids and a forced air warm blanket.

Induction of general anesthesia will be done using inhalational sevoflurane at 8%, and after loss of consciousness, a peripheral intravenous access will be placed under complete aseptic condition. Fentanyl citrate at 1 µg/kg will be slowly injected intravenously then laryngeal mask with appropriate size will be inserted.

Maintenance of anesthesia will be with 50% oxygen-air mixture, and sevoflurane titrated to a minimum alveolar concentration MAC of 2%. Ringer acetate will be administered as the intraoperative maintenance fluid at the rate of 6 mL/kg/h.

The baseline value of PPI, heart rate (HR), and mean arterial pressure (MAP) will be recorded, corresponding to the value at 0 minute (T0) measured after induction of general anesthesia and before caudal block in supine position. The caudal block will be performed under complete aseptic conditions with the patient in the left lateral decubitus position with the hips and knees flexed using the landmark technique. Sterilization by Povidone Iodine will take place and insertion of the cannula will begin till appreciating the loss of resistance at which the needle is will be held and the cannula is advanced. After negative aspiration for blood and cerebrospinal fluid, 1mL/kg of 0.25% of bupivacaine hydrochloride will be injected at the rate of 1mL/3s and the patient will be turned supine immediately and surgical skin incision will be allowed to start 10 minutes after.

Following the caudal block, PPI, HR, and MAP will be recorded at 2, 5, 7, 10 (at skin incision), 15, and 20 minutes. Successful caudal block will be predicted as any or both of the following criteria achieved, whichever occurred earlier:

* ≥100% increase of PPI value from baseline. * No tachycardia or hypertension on surgical stimulation (HR or MAP increase \> 20% of baseline).

Percentage of successful blocks predicted with these criteria will be plotted against postoperative pain score as a main determinant of caudal block success with successful block defined as the following:

• Postoperative pain score as assessed by Children and Infants' Postoperative Pain Scale (CHIPPS) at 0 h and 30 min postoperatively is \<4 out of 10.

A failed caudal block is defined based on failure to achieve the aforementioned criteria. And in case of block failure, an intravenous bolus of 1-2 ug/kg fentanyl will be administered intraoperatively, and a rescue post-operative analgesia in the form of bolus intravenous nalbuphine at a dose of 0.2 mg/kg will be provided to patients accordingly.

Patients will be divided into two groups based on success of the block: group (S) caudal success group, and group (F) caudal failure group. Both groups will receive the standard management (caudal block under general anesthesia) for the required procedure. There will not be a control group for this study.

Interventions

  • Device Peripheral perfusion index pulse oximeter
    Masimo pulse oximeter probe for measuring peripheral perfusion index and predicting success of caudal block

Primary outcome measures

  • peripheral perfusion index predictability [Time frame: From enrollment to discharge from post anesthesia care unit]

Eligibility criteria

Inclusion criteria

  • Pediatric patients aging between 1-5 years of both sexes.
  • Pediatric patients posted for elective lower abdominopelvic surgeries under general anesthesia (duration of surgery under 120 minutes).
  • ASA physical status classes I - II.

Exclusion criteria

  • Guardian's refusal of procedure or participation in the study.
  • ASA classes III or above.
  • Infection at site of injection.
  • Neurological diseases and disorders such as (neuromuscular disease, cerebral palsy, spinal dysraphism …etc.)
  • Coagulopathy and bleeding disorders.
  • Hypersensitivity to the study medications.
  • Patients receiving vasoactive drugs or beta blockers.
  • Patients undergoing emergency surgery.
  • Patients in active clinical sepsis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Publications

  • Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):3 PMID 28045707
  • Zielinski J, Morawska-Kochman M, Zatonski T. Pain assessment and management in children in the postoperative period: A review of the most commonly used postoperative pain assessment tools, new diagnostic methods and the latest guidelines for postoperative pain therapy in children. Adv Clin Exp Med. 2020 Mar;29(3):365-374. doi: 10.17219/acem/112600. PMID 32129952
  • Wolf AR. Effects of regional analgesia on stress responses to pediatric surgery. Paediatr Anaesth. 2012 Jan;22(1):19-24. doi: 10.1111/j.1460-9592.2011.03714.x. Epub 2011 Oct 14. PMID 21999144
  • Wiegele M, Marhofer P, Lonnqvist PA. Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517. doi: 10.1016/j.bja.2018.11.030. Epub 2019 Feb 1. PMID 30857607
  • Toyama S, Kakumoto M, Morioka M, Matsuoka K, Omatsu H, Tagaito Y, Numai T, Shimoyama M. Perfusion index derived from a pulse oximeter can predict the incidence of hypotension during spinal anaesthesia for Caesarean delivery. Br J Anaesth. 2013 Aug;111(2):235-41. doi: 10.1093/bja/aet058. Epub 2013 Mar 21. PMID 23518802
  • Szostek AS, Saunier C, Elsensohn MH, Boucher P, Merquiol F, Gerst A, Portefaix A, Chassard D, De Queiroz Siqueira M. Effective dose of ephedrine for treatment of hypotension after induction of general anaesthesia in neonates and infants less than 6 months of age: a multicentre randomised, controlled, open label, dose escalation trial. Br J Anaesth. 2023 May;130(5):603-610. doi: 10.1016/j.bja.2022. PMID 36639328
  • Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702. PMID 29319604
  • Sekimoto K, Tobe M, Saito S. Local anesthetic toxicity: acute and chronic management. Acute Med Surg. 2017 Mar 6;4(2):152-160. doi: 10.1002/ams2.265. eCollection 2017 Apr. PMID 29123854

Identifiers

NCT: NCT06846983 · FMASU MD325/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗