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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03056261
Recruitment Status : Unknown
Verified February 2017 by MOSTAFA.SOMRI, Bnai Zion Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 17, 2017
Last Update Posted : February 20, 2017
Information provided by (Responsible Party):
MOSTAFA.SOMRI, Bnai Zion Medical Center

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 and fentanyl (2-4 µ and will receive rocuronium bromide (0.5 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 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 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 µ The amount of fentanyl required for adequate postoperative pain relief will be recorded in both groups.

Condition or disease Intervention/treatment Phase
Epidural Anesthesia Infection Infant, Newborn, Diseases Procedure: Combined general and epidural Procedure: General anaesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: comaring combined general anesthesia and epidural technique to general anaesthsia alone or gastrointestinal recovery and pain managment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: Combined general and epidural
Combined general and epidural anesthesia in infants UNDERGOING INTESTINAL SURGERY
Procedure: Combined general and epidural
Combined general and epidural anaesthesia

Placebo Comparator: General anaesthesia
General anesthesia in infants UNDERGOING INTESTINAL SURGERY
Procedure: General anaesthesia
General anaesthesia

Primary Outcome Measures :
  1. 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. [ Time Frame: upto 20 days postoperative ]

    The outcomes measured to determine recovery of intestinal function recovery:

    1. Time to first postoperative defecation measured in hours or days
    2. Duration of nasogastric feeding measured in hours or days
    3. Time to tolerance of full oral feeding measured in hours or days

Secondary Outcome Measures :
  1. Rate and sort of postoperative infection [ Time Frame: upto 20 days postoperative ]
    1. Surgical site infection (SSI)
    2. Remote site infection (RSI)

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Ages Eligible for Study:   1 Month to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03056261

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Contact: Mostafa Somri, MD #972-4-8359346

Sponsors and Collaborators
Bnai Zion Medical Center
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Principal Investigator: Mostafa Somri, M.D. Bnai Zion Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MOSTAFA.SOMRI, Prof Mostafa Somri, Bnai Zion Medical Center Identifier: NCT03056261    
Other Study ID Numbers: BnaiZionMC-16-MS-004
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MOSTAFA.SOMRI, Bnai Zion Medical Center:
Combined general-epidural anesthesia intestinal recovery
Additional relevant MeSH terms:
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Infant, Newborn, Diseases
Central Nervous System Depressants
Physiological Effects of Drugs