Stress Response and Hemodynamic Changes Associated With Intrathecal Anesthesia Versus Caudal Epidural Anesthesia in Infants Undergoing Laparoscopic Inguinal Herniorrhaphy

NCT06909396 | Completed

• 1 other identifier: 35680/8/22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work was to assess stress response and hemodynamic changes associated with intrathecal anesthesia versus caudal epidural anesthesia in infants undergoing laparoscopic inguinal herniorrhaphy.

Conditions

Stress Response; Hemodynamic Changes; Intrathecal Anesthesia; Caudal Epidural Anesthesia; Infants; Laparoscopic Inguinal Herniorrhaphy

Outcome Measures

Primary Outcomes (1)

• Serum glucose level

  Serum glucose level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.

  24 hours postoperatively

Secondary Outcomes (5)

• Serum cortisol level

  24 hours postoperatively

• Heart rate

  Till the end of surgery (Up to 1 hour)

• Mean arterial pressure

  Till the end of surgery (Up to 1 hour)

• Intraoperative anesthetic consumption

  Intraoperatively

• Total analgesics consumption

  24 hours postoperatively

Study Arms (3)

Control group

ACTIVE COMPARATOR

Patients received general anesthesia.

Drug: General anesthesia

Intrathecal group

EXPERIMENTAL

Patients received intrathecal anesthesia.

Drug: Intrathecal Anesthesia

Caudal block group

EXPERIMENTAL

Patients received caudal epidural anesthesia.

Drug: Caudal block

Interventions

General anesthesia DRUG

Patients received general anesthesia

Control group

Intrathecal Anesthesia DRUG

Patients received intrathecal Anesthesia

Intrathecal group

Caudal block DRUG

Patients received caudal epidural anesthesia.

Caudal block group

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from full term one month to one year.
• Both sexes.
• Patients with clinical criteria of laparoscopic inguinal herniorrhaphy.

You may not qualify if:

• Refusal of patients' parents.
• Diseases of the central nervous system.
• Patients with metabolic and coagulation defects.
• Pre-term infant.
• Infection at the site of injection.
• Congenital anomaly in vertebral column.
• Patient treated with corticosteroids.
• Patients with respiratory dysfunction.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Fractures, Stress

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: June 1, 2023
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)