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

NCT03095144 | Unknown DMC FDA Device

• 1 other identifier: BnaiZionMC-17-MS-001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertrophic Pyloric Stenosis; Spinal Anesthesia; General Anesthesia

Keywords

pyloromyotomy; spinal anaesthesia; surgical outcomes; general anaesthesia; infants

Outcome Measures

Primary Outcomes (3)

• Total operating room time

  The elapsing time since entrance to the operating room until transport to the post anaesthesia care unit or neonatal intensive care unit in mins.

  1 hour

• Pain management

  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

  1-24 hours

• Time of regaining full enteral feeding

  Time of regaining full enteral feeding

  up to 48 hours

Secondary Outcomes (1)

• Number of substantial vomiting

  up to 24 hours

Study Arms (2)

Spinal anesthesia

Lumbar puncture was performed with a midline approach through either the fourth or fifth lumbar space using a 22 or 25 -gauge 4 cm disposable styletted needle. Spinal isobaric Bupivacaine 0.5%, 0.8-1 mg.kg-1 without epinephrine was injected using a 1ml tuberculin syringe.

Device: Spinal anesthesia

General anesthesia

The General anesthesia is preformed by intravenous Propofol (2-4 mg.kg-1) and Fentanyl (1-2 µg.kg-1) and Rocuronium bromide (0.5mg.kg-1) administration to facilitate endotracheal intubation, assisted by Sellick manoeuvre. Anaesthesia maintenance with Sevoflurane (2-3%) in an air/oxygen mixture, intravenous Fentanyl as required.

Device: General anesthesia

Interventions

Spinal anesthesia DEVICE

Pyloromyotomy under spinal anesthesia

Spinal anesthesia

General anesthesia DEVICE

Pyloromyotomy under general anesthesia

General anesthesia

Eligibility Criteria

• Age: 4 Weeks - 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with HPS, treated by open pyloromyotomy under Spinal Anesthesia in our medical center

You may qualify if:

• Children well hydrated: a normal serum electrolyte count;

You may not qualify if:

• Children who's spinal puncture was unsuccessful even after a third attempt.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic

Interventions

Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Mostafa Somri, Prof

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Somri, Prof

CONTACT

# 972-4-8359304; mostafa.somri@b-zion.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIRECTOR OF ANESTHESIA DEPARTEMT

Study Record Dates

• First Submitted: March 19, 2017
• First Posted: March 29, 2017
• Study Start: May 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 29, 2017

Record last verified: 2017-03