search
Back to results

The Effect of Combined General-epidural vs General Anaesthesia on Postoperative Gastrointestinal Surgery

Primary Purpose

Epidural Anesthesia, Infection, Infant, Newborn, Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined general and epidural
General anaesthesia
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidural Anesthesia focused on measuring Combined general-epidural anesthesia intestinal recovery

Eligibility Criteria

1 Month - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neonates or infants requiring the following major intestinal procedures: duodenoduodenostomy or duodenojejunostomy for duodenal atresia,
  • ileocaecal resection for intestinal volvulus,
  • ileostomy or colostomy closure for congenital anorectal malformations,
  • corrective surgery for Hirschsprung's disease. emergent intestinal surgery.

Exclusion Criteria:

  • The exclusion criteria are concurrent coagulopathies,
  • sepsis,
  • vertebral column malformations,
  • neurological disease,
  • immunocompromise with or without leukopenia,
  • intestinal necrotising enterocolitis.
  • Patients will be also excluded if they required exploratory laparotomy or or emergent intestinal surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Combined general and epidural

    General anaesthesia

    Arm Description

    Combined general and epidural anesthesia in infants UNDERGOING INTESTINAL SURGERY

    General anesthesia in infants UNDERGOING INTESTINAL SURGERY

    Outcomes

    Primary Outcome Measures

    Postoperative intestinal function recovery for neonates and infants undergoing gastrointestinal surgery. Which anesthetic method be superior and favoured as normal practice general or combined general and epidural anesthesia.
    The outcomes measured to determine recovery of intestinal function recovery: Time to first postoperative defecation measured in hours or days Duration of nasogastric feeding measured in hours or days Time to tolerance of full oral feeding measured in hours or days

    Secondary Outcome Measures

    Rate and sort of postoperative infection
    Surgical site infection (SSI) Remote site infection (RSI)

    Full Information

    First Posted
    February 12, 2017
    Last Updated
    February 17, 2017
    Sponsor
    Bnai Zion Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03056261
    Brief Title
    The Effect of Combined General-epidural vs General Anaesthesia on Postoperative Gastrointestinal Surgery
    Official Title
    The Effect of Combined General-epidural vs General Anaesthesia on Postoperative Intestinal Function Recovery and Infection in Neonates and Infants Undergoing Gastrointestinal Surgery: a Prospective, Randomised, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2017 (Anticipated)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bnai Zion Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Sixty neonates and infants will be enrolled and randomised into two groups of n=30 each . For their surgical procedures, one group general (GA) anaesthesia the second group will receive a combined general and epidural anaesthesia (CGEA). Anaesthetic technique: Patients in the GA group will be induced with intravenous propofol (2-4 mg.kg-1) and fentanyl (2-4 µg.kg-1) and will receive rocuronium bromide (0.5 mg.kg-1) to facilitate endotracheal intubation. Anaesthesia will be maintained with sevoflurane (2-3%) in an air/oxygen mixture as well as intravenous fentanyl as required. In the (CGEA) 0.5 ml.kg-1 of 0.25% bupivacaine will be injected into the epidural catheter, followed by a continuous infusion of 0.1% bupivacaine at a rate of 0.2 mg.kg-1.hr-1 for up to 48 hours postoperatively. Assessment of anaesthetic efficacy will be measured Intraoperative care vital signs. And will continuously be monitored with a Datex AS/3 (Engestrom®, Helsinki, Finland) monitor. The use of antibiotic prophylaxis will be determined by the degree of bowel contamination during surgery, with the commonest regimen consisting of penicillin, gentamicin and metronidazole will be administered. Antibiotics will be continued for 36-48 hours postoperatively to prevent infection arising from the disturbed bowel flora. Postoperative care, following surgery, will be conducted. The feeding volume will be increased in steps as long as the volume of regurgitated fluid will be less than 20% of the administered breast milk or formula volume. Full feeding will define as oral tolerance of at least 80% of daily maintenance volume. In cases of abdominal distension or vomiting, feeding will withheld until symptom resolution. The nasogastric tube will be removed on bowel function restoration The CRIES score will be use to assess the severity and duration of postoperative pain during the patients' NICU stay. If the CRIES score is ≥4, fentanyl will be continuously intravenously infused in both study group. Fentanyl will be also administered to CGEA patients who experienced pain despite a continuous epidural infusion at 1-5 µg.kg-1.h-1. The amount of fentanyl required for adequate postoperative pain relief will be recorded in both groups.
    Detailed Description
    After approval off the local Ethical Committee of Bnai Zion Hospital, Haifa, Israel and informed parental consent obtained for each participant. Sixty small infants who undergoing GI surgery will be enrolled in this study. The inclusion criteria are neonates or infants requiring the following major intestinal procedures: duodenoduodenostomy or duodenojejunostomy for duodenal atresia, ileocaecal resection for intestinal volvulus, ileostomy or colostomy closure for congenital anorectal malformations, and corrective surgery for Hirschsprung's disease. The exclusion criteria are concurrent coagulopathies, sepsis, vertebral column malformations, neurological disease, immunocompromise with or without leukopenia, and intestinal necrotising enterocolitis. Patients will be also excluded if they will require exploratory laparotomy or emergent intestinal surgery. Sixty premature, ex-premature, and full-term neonates and infants meeting the above criteria will enrolled in the study, patients will randomised into two groups of n=30 each ( according to a computer program ) . For their surgical procedures, the first group will receive general anesthesia (GA group), whereas the second group receive combined general and epidural anesthesia (CGEA group). Anesthetic technique Patients in the GA group will be induced with intravenous propofol (2-4 mg.kg-1) and fentanyl (2-4 µg.kg-1) and receive rocuronium bromide (0.5 mg.kg-1) to facilitate endotracheal intubation. Anaesthesia will be maintained with sevoflurane (2-3%) in an air/oxygen mixture as well as intravenous fentanyl as required. Patients in the CGEA group will be induce as above in addition to receiving epidural anaesthesia as follows: A 20G epidural catheter (B. Braun Medical Ltd., Melsungen, Germany) through a 19G Crawford epidural needle, so that its tip lays between the desired T5 and T10 spinal segments. Correct catheter placement will be confirmed by portable epidurography after filling the catheter with 0.5 ml iohexol (Omnipaque® 300, Nycomed, Oslo, Norway). A test dose of 0.1 ml.kg-1 of 1% lidocaine with 1:200 000 adrenaline will be administered, and the result and effects on heart rate (HR) and the ST segment will be noted. If the HR increases by at least 20% above baseline and/or ST segment changes will be observed, the catheter will be withdrawl and re positioned. 0.5 ml.kg-1 of 0.25% bupivacaine will be injected into the epidural catheter, followed by a continuous infusion of 0.1% bupivacaine at a rate of 0.2 mg.kg-1.hr-1 for up to 48 hours postoperatively. Assessment of anesthetic efficacy in both groups will be confirmed by the absence of surges in blood pressure (BP) and HR beyond 20% above baseline. Success of epidural anesthesia will be defined by the correct placement of the epidural catheter between the T5 and T10 spinal segments within two attempts, as well as the obviation for additional systemic analgesia. In cases of epidural technique failure, anesthesia will be maintained by GA and the patient will be removed from the study. Intraoperative care Intraoperative systolic, diastolic and mean arterial pressures (SBP, DBP, and MAP), HR, arterial oxygen saturation(SaO2), and temperature will be continuously monitored with a Datex AS/3 (Engestrom®, Helsinki, Finland) monitor. All patients in the GA group will mechanically be ventilated, with maintenance of peak inspiratory pressure between 18 and 30 cmH20, and end-tidal CO2 (ETCO2) between 30 and 50 mmHg. Additionally, urine output will be measured at 30-minute intervals. Two peripheral intravenous cannulae will be inserted preoperatively for each patient, and fluid will be maintained with Ringer's lactate and 5% glucose solutions at 4 ml.kg-1.h-1. Additional Ringer's lactate will be infused for fluid replacement of third-space and/or blood losses. Packed red blood cells will be transfused in cases of blood loss ≥10% of blood volume. The use of antibiotic prophylaxis will be determined by the degree of bowel contamination during surgery, with the commonest regimen consisting of penicillin, gentamicin and metronidazole will be administered. Antibiotics will continue for 36-48 hours postoperatively to prevent infection arising from the disturbed bowel flora. Postoperative care following surgery, all patients will be transferred to the neonatal intensive care unit (NICU) where physiological monitoring and mechanical ventilation will continue as appropriate. Blood samples will be collected postoperatively for full blood count, glucose, electrolyte, and blood gas measurement. The feeding volume will be increased in 5 ml steps as long as the volume of regurgitated fluid is less than 20% of the administered breast milk or formula volume. Full feeding will be defined as oral tolerance of at least 80% of daily maintenance volume. In cases of abdominal distension or vomiting, feeding will withheld until symptom resolution. The nasogastric tube will be removed on bowel function restoration (i.e. defaecation). The CRIES neonatal postoperative pain score (C=Crying; R=Requires oxygen; I=Increased vital signs; E=Expression; S=Sleepless) [18] will be used to assess the severity and duration of postoperative pain during the patients' NICU stay. Scoring will carried out by the attending nurses every two hours. If the CRIES score is ≥4, fentanyl will be continuously intravenously infused in both study group. Fentanyl will be also administered to CGEA patients who experienced pain despite a continuous epidural infusion at 1-5 µg.kg-1.h-1. The amount of fentanyl required for adequate postoperative pain relief will recorded in both groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epidural Anesthesia, Infection, Infant, Newborn, Diseases
    Keywords
    Combined general-epidural anesthesia intestinal recovery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    comaring combined general anesthesia and epidural technique to general anaesthsia alone or gastrointestinal recovery and pain managment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Combined general and epidural
    Arm Type
    Experimental
    Arm Description
    Combined general and epidural anesthesia in infants UNDERGOING INTESTINAL SURGERY
    Arm Title
    General anaesthesia
    Arm Type
    Placebo Comparator
    Arm Description
    General anesthesia in infants UNDERGOING INTESTINAL SURGERY
    Intervention Type
    Procedure
    Intervention Name(s)
    Combined general and epidural
    Intervention Description
    Combined general and epidural anaesthesia
    Intervention Type
    Procedure
    Intervention Name(s)
    General anaesthesia
    Intervention Description
    General anaesthesia
    Primary Outcome Measure Information:
    Title
    Postoperative intestinal function recovery for neonates and infants undergoing gastrointestinal surgery. Which anesthetic method be superior and favoured as normal practice general or combined general and epidural anesthesia.
    Description
    The outcomes measured to determine recovery of intestinal function recovery: Time to first postoperative defecation measured in hours or days Duration of nasogastric feeding measured in hours or days Time to tolerance of full oral feeding measured in hours or days
    Time Frame
    upto 20 days postoperative
    Secondary Outcome Measure Information:
    Title
    Rate and sort of postoperative infection
    Description
    Surgical site infection (SSI) Remote site infection (RSI)
    Time Frame
    upto 20 days postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    6 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Neonates or infants requiring the following major intestinal procedures: duodenoduodenostomy or duodenojejunostomy for duodenal atresia, ileocaecal resection for intestinal volvulus, ileostomy or colostomy closure for congenital anorectal malformations, corrective surgery for Hirschsprung's disease. emergent intestinal surgery. Exclusion Criteria: The exclusion criteria are concurrent coagulopathies, sepsis, vertebral column malformations, neurological disease, immunocompromise with or without leukopenia, intestinal necrotising enterocolitis. Patients will be also excluded if they required exploratory laparotomy or or emergent intestinal surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mostafa Somri, MD
    Phone
    #972-4-8359346
    Email
    mostafa.somri@b-zion.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mostafa Somri, M.D.
    Organizational Affiliation
    Bnai Zion Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31506919
    Citation
    Gannam-Somri L, Matter I, Hadjittofi C, Vaida S, Khalaily H, Hossein J, Somri M. Combined epidural-general anaesthesia vs general anaesthesia in neonatal gastrointestinal surgery: A randomized controlled trial. Acta Anaesthesiol Scand. 2020 Jan;64(1):34-40. doi: 10.1111/aas.13469. Epub 2019 Oct 7.
    Results Reference
    derived

    Learn more about this trial

    The Effect of Combined General-epidural vs General Anaesthesia on Postoperative Gastrointestinal Surgery

    We'll reach out to this number within 24 hrs