The Effect of Combined General-epidural vs General Anaesthesia on Postoperative Gastrointestinal Surgery
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFebruary 20, 2017
February 1, 2017
2 months
February 12, 2017
February 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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
upto 20 days postoperative
Secondary Outcomes (1)
Rate and sort of postoperative infection
upto 20 days postoperative
Study Arms (2)
Combined general and epidural
EXPERIMENTALCombined general and epidural anesthesia in infants UNDERGOING INTESTINAL SURGERY
General anaesthesia
PLACEBO COMPARATORGeneral anesthesia in infants UNDERGOING INTESTINAL SURGERY
Interventions
Combined general and epidural anaesthesia
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31506919DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mostafa Somri, M.D.
Bnai Zion Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Mostafa Somri
Study Record Dates
First Submitted
February 12, 2017
First Posted
February 17, 2017
Study Start
April 1, 2017
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
February 20, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share