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

NCT06846983 | Recruiting

• 1 other identifier: FMASU MD325/2024
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Perfusion Index; Caudal Block

Keywords

Peripheral perfusion index; caudal block; predictor

Outcome Measures

Primary Outcomes (1)

• peripheral perfusion index predictability

  Monitor and compare peripheral perfusion index values before and after administration of the caudal block to determine if there is a significant correlation between early PPI changes and the success of caudal block

  From enrollment to discharge from post anesthesia care unit

Interventions

Peripheral perfusion index pulse oximeter DEVICE

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

Also known as: Masimo pulse oximeter

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All pediatric patients undergoing elective lower abdominopelvic surgeries under general anesthesia at El-Demerdash Pediatric Surgery Hospital during the study period. Surgeries include inguinal / inguinoscrotal hernia repair, hydrocelectomy, orchiopexy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, 11566, Egypt

RECRUITING

Related Publications (21)

• 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):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

  PMID: 28045707 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.2022.12.006. Epub 2023 Jan 12.

  PMID: 36639328 BACKGROUND

• 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 BACKGROUND

• Sun X, He H, Xu M, Long Y. Peripheral perfusion index of pulse oximetry in adult patients: a narrative review. Eur J Med Res. 2024 Sep 11;29(1):457. doi: 10.1186/s40001-024-02048-3.

  PMID: 39261939 BACKGROUND

• Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9.

  PMID: 16682915 BACKGROUND

• 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 BACKGROUND

• Rajan K, Dave N, Dias R, Muneshwar P, Kesarkar N, Saxena V. Perfusion index as a predictor of working pediatric caudal block under general anesthesia- A prospective observational study. J Anaesthesiol Clin Pharmacol. 2022 Oct-Dec;38(4):635-639. doi: 10.4103/joacp.JOACP_34_21. Epub 2022 Dec 26.

  PMID: 36778797 BACKGROUND

• Piasek CZ, Van Bel F, Sola A. Perfusion index in newborn infants: a noninvasive tool for neonatal monitoring. Acta Paediatr. 2014 May;103(5):468-73. doi: 10.1111/apa.12574. Epub 2014 Feb 23.

  PMID: 24471645 BACKGROUND

• Nemeth M, Miller C, Brauer A. Perioperative Hypothermia in Children. Int J Environ Res Public Health. 2021 Jul 15;18(14):7541. doi: 10.3390/ijerph18147541.

  PMID: 34299991 BACKGROUND

• Menzies R, Congreve K, Herodes V, Berg S, Mason DG. A survey of pediatric caudal extradural anesthesia practice. Paediatr Anaesth. 2009 Sep;19(9):829-36. doi: 10.1111/j.1460-9592.2009.03116.x.

  PMID: 19691690 BACKGROUND

• Kubica-Cielinska A, Zielinska M. The use of nalbuphine in paediatric anaesthesia. Anaesthesiol Intensive Ther. 2015;47(3):252-6. doi: 10.5603/AIT.2015.0036.

  PMID: 26165241 BACKGROUND

• • Elfeil YE, Zarad AR, Deghidy EA. Comparison of two different methods as reliable predictors of successful caudal block in children. Egypt J Anaesth. 2024; 40(1): 69-74.

  BACKGROUND

• • El-Sonbaty M, El-Sonbaty A. Evaluation of Perfusion index (PI) efficiency in pediatric caudal block: Is it the time to depend on PI? Med J Cairo Univ. 2015; 83:223-7.

  BACKGROUND

• Coutrot M, Dudoignon E, Joachim J, Gayat E, Vallee F, Depret F. Perfusion index: Physical principles, physiological meanings and clinical implications in anaesthesia and critical care. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100964. doi: 10.1016/j.accpm.2021.100964. Epub 2021 Oct 24.

  PMID: 34687923 BACKGROUND

• Benka AU, Pandurov M, Galambos IF, Rakic G, Vrsajkov V, Draskovic B. [Effects of caudal block in pediatric surgical patients: a randomized clinical trial]. Braz J Anesthesiol. 2020 Mar-Apr;70(2):97-103. doi: 10.1016/j.bjan.2019.12.003. Epub 2020 Feb 20.

  PMID: 32204919 BACKGROUND

• Baduni N, Sanwal MK, Vajifdar H, Agarwala R. Postoperative analgesia in children: A comparison of three different doses of caudal epidural morphine. J Anaesthesiol Clin Pharmacol. 2016 Apr-Jun;32(2):220-3. doi: 10.4103/0970-9185.182106.

  PMID: 27275053 BACKGROUND

• Allen J. Photoplethysmography and its application in clinical physiological measurement. Physiol Meas. 2007 Mar;28(3):R1-39. doi: 10.1088/0967-3334/28/3/R01. Epub 2007 Feb 20.

  PMID: 17322588 BACKGROUND

Study Officials

• Omar Mohamed Taha Abdallah El-Safty, M.B.B.CH., MD.

  Faculty of Medicine, Ain Shams University

  STUDY CHAIR

Central Study Contacts

Mohamed Khaled Mohamed Ahmed, M.B.B.CH., M.Sc.

CONTACT

+2001069123693; mohamed.mohsen@med.asu.edu.eg

Yassmin Hassan Abdelsattar Abdelbary, M.B.B.CH., MD.

CONTACT

+2001095140964

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: January 2, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

EG (1)