Clinical Trial: Spinal Anesthesia and General Anesthesia for Pyloromyotomy - Surgical Outcomes a Comparison Retrospective Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: A Retrospective Comparative Study, Post Operative Outcomes of Pyloromyotomy Procedure Under Spinal Anesthesia Compared to General Anesthesia

Brief Summary:

Background: The purpose of this retrospective study is to evaluate surgical outcomes of pyloromyotomy in infants performed under spinal anesthesia compares to general anesthesia.

Methods: After receiving the approval of the hospital ethics committee, retrieving, reviewing files and collecting data. Primary outcomes: total operating room time, duration of surgery, pain management and postoperative apnea episodes, time of regaining full enteral feeding. Secondary outcome measures: include cardio-respiratory changes and events, and substantial vomiting postoperatively.


Detailed Summary:

After receiving of the approval of the MedicalCenter Ethics Committee, the files of all infants with hypertrophic pyloric stenosis, who were treated by open pyloromyotomy under Spinal Anesthesia and general anesthesia in Bnai-Zion Medical Center through a decade will be reviewed.

Primary outcomes: total operation time, pain assessment and management, postoperative apnea episodes and time for regaining full enteral feeding. Secondary outcome measures include, significant cardiorespiratory changes and substantial postoperative vomiting.

Full enteral feeding is defined as an infant tolerating 130 ml.kg-1 of formula a day, or breast feeding in 6-8 divided doses. Infants tolerating 2-3 full enteral feedings without complications were discharged.

Total operating room time defined as the elapsing time since entrance to the operating room until transport to the post anesthesia care unit or neonatal intensive care unit .

Surgical time is defined as the elapsing time since performing the surgical incision until wound dressing .

All infants assisted by the CRIES pain score for pain measurement and management after surgery. The CRIES score, (which is the abbreviation of C - Crying, R - Requires increase oxygen administration, I - Increased vital signs, E - Expression, S- Sleeplessness), obtained by nurses each 4 hours.

Anesthesia pharmacological Paracetamol 25 mg.kg-1 administered rectally to all infants prior to surgery. Fentanyl 1mg.Kg-1 ordered IV by the anesthetist in titration dose for pain control in PACU, and Paracetamol 15 mg.kg-1 ordered by the paediatric surgeon rectally for postoperative pain in the surgical ward, as needed. Bi
Sponsor: Bnai Zion Medical Center

Current Primary Outcome:

  • Total operating room time [ Time Frame: 1 hour ]
    The elapsing time since entrance to the operating room until transport to the post anaesthesia care unit or neonatal intensive care unit in mins.
  • Pain management [ Time Frame: 1-24 hours ]
    The CRIES score, (which is the abbreviation of C - Crying, R - Requires increase oxygen administration, I - Increased vital signs, E - Expression, S- Sleeplessness), obtained by nurses each 4 hours
  • Time of regaining full enteral feeding [ Time Frame: up to 48 hours ]
    Time of regaining full enteral feeding


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of substantial vomiting [ Time Frame: up to 24 hours ]

Follow-up of number of vomiting events


Original Secondary Outcome: Same as current

Information By: Bnai Zion Medical Center

Dates:
Date Received: March 19, 2017
Date Started: May 2017
Date Completion: December 2017
Last Updated: March 28, 2017
Last Verified: March 2017