Hypertrophic Pyloric StenosisNCT03095144
Spinal Anesthesia and General Anesthesia for Pyloromyotomy - Surgical Outcomes a Comparison Retrospective Study
An observational study of Hypertrophic Pyloric Stenosis and Spinal Anesthesia, run by Bnai Zion Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 weeks
- Conditions the study is for
- Hypertrophic Pyloric Stenosis, Spinal Anesthesia, General Anesthesia
- What is being tested?
- Spinal anesthesia and General anesthesia
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2017to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants with HPS, treated by open pyloromyotomy under Spinal Anesthesia in our medical center
Who may be able to join
- Children well hydrated: a normal serum electrolyte count;
Who cannot join
- Children who's spinal puncture was unsuccessful even after a third attempt.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Retrospective Comparative Study, Post Operative Outcomes of Pyloromyotomy Procedure Under Spinal Anesthesia Compared to General Anesthesia
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.
Read the detailed description
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. Bilateral ultra sound- guided rectus sheath block performed at the end of surgery.
Respiratory monitoring f performed in the NICU using Vitalmon® 5010 (Kontron Instruments, France), with the nursing staff recording occurrences of apnea, desaturation, and bradycardia.
A long apnea defined as a respiratory pause of 15 seconds or longer, or any apnea that coincided with the appearance of bradycardia.
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.
All spinal blocks performed by the same consultant anesthesiologist group. The infant's back prepared scrubbed with chlorhexidine solution. Lumbar puncture 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 injected using a 1ml tuberculin syringe.
Standard monitoring during anaesthesia included: heart rate, blood pressure by non-invasive means, skin temperature and blood oxygen saturation (SpO2) using the AS/3® monitor (Datex, Engestrom, Helsinki, Finland). The above monitored parameters were applied before performing the spinal block, and subsequently every 5 minutes after the spinal block, until the end of surgery. In all infants, the stomach was suctioned until no further gastric fluid was obtained.
Effective spinal block was defined by the infant's inability to move the lower extremities. The sensory level of anesthesia was determined by observing the patient's segmental response to a tetanic stimulus of 10-30 milli-amperes, delivered by a peripheral nerve stimulator (Innervator® NS252, Fisher and Pajkel Healthcare Electronics Ltd, Auckland, New Zealand). Attainment of sensory block was indicated by the lack of crying, flexure of the upper extremities and an increase in both the heart and respiratory rate by 15% above baseline.
Bradycardia is defined as less than 100 bpm, and hypoxia is defined as O2 saturation of less than 95 % for more than 30 seconds. An increase in blood pressure and heart rate of more than 15% above the baseline considered clinically significant.
All the surgical pyloromyotomy procedures were performed by the same paediatric surgeon group, using open Fredet-Ramstedt technique through a supraumbilical transverse right upper quadrant incision. For inadequate relaxation or if persistent discomfort was noticed, infants who were given a single dose bolus of IV Diprivan, (0.5-1 mg.kg-1), or a titration dose of midazolam (0.05-0.1 mg.kg-1).
Intra-operatively, the infants were hydrated with 5% dextrose in a 0.45% NaCl solution at a rate of 5 ml.kg-1.h-1 using an infusion pump.
Statistical analysis:
For the demographic continuous variables (age, weight and height at surgery) and the surgical continuous variables (duration of surgery, duration of spinal anesthesia, total time in operating room, regain of full feeding time and home discharge day) means, standard deviations, medians, ranges and IQR (the difference between Q3 and Q1) will be calculated.
For the categorical variables (number of spinal attempts and sedation required), numbers and percentages will be calculated.
For the continuous repeated measures of respiratory rate, oxygen saturation rates, mean blood pressure and heart rate at six periods of times, the means and standard deviations were calculated, and the results analyzed by the Anova repeated-measures test.
All statistical tests analyzed to a significance level of 0.05. Statistical analysis performed using the STATA 12.0 software.
- Being tested
- Spinal anesthesia, General anesthesia
- Keywords
- pyloromyotomy, spinal anaesthesia, surgical outcomes, general anaesthesia, infants
- Medical subject headings
- Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaDevice
Pyloromyotomy under spinal anesthesia
General anesthesiaDevice
Pyloromyotomy under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1-24 hours
Time of regaining full enteral feeding
Time of regaining full enteral feeding
Measured: up to 48 hours
Secondary outcomes (1)
Number of substantial vomiting
Follow-up of number of vomiting events
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startMay 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Pyloric StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MOSTAFA.SOMRI, Bnai Zion Medical Center
- Investigators
- Mostafa Somri, Prof, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095144
- Sponsor's protocol ID
- BnaiZionMC-17-MS-001
- Status last verified
- Mar 2017
- First submitted
- 19 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Comparative Study, Post Operative Outcomes of Pyloromyotomy Procedure Under Spinal Anesthesia Compared to General Anesthesia
- ClinicalTrials.gov ID
- NCT03095144
- Acronym / sponsor ID
- BnaiZionMC-17-MS-001
- Keywords
- pyloromyotomy, spinal anaesthesia, surgical outcomes, general anaesthesia, infants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- May 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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. Bilateral ultra sound- guided rectus sheath block performed at the end of surgery.
Respiratory monitoring f performed in the NICU using Vitalmon® 5010 (Kontron Instruments, France), with the nursing staff recording occurrences of apnea, desaturation, and bradycardia.
A long apnea defined as a respiratory pause of 15 seconds or longer, or any apnea that coincided with the appearance of bradycardia.
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.
All spinal blocks performed by the same consultant anesthesiologist group. The infant's back prepared scrubbed with chlorhexidine solution. Lumbar puncture 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 injected using a 1ml tuberculin syringe.
Standard monitoring during anaesthesia included: heart rate, blood pressure by non-invasive means, skin temperature and blood oxygen saturation (SpO2) using the AS/3® monitor (Datex, Engestrom, Helsinki, Finland). The above monitored parameters were applied before performing the spinal block, and subsequently every 5 minutes after the spinal block, until the end of surgery. In all infants, the stomach was suctioned until no further gastric fluid was obtained.
Effective spinal block was defined by the infant's inability to move the lower extremities. The sensory level of anesthesia was determined by observing the patient's segmental response to a tetanic stimulus of 10-30 milli-amperes, delivered by a peripheral nerve stimulator (Innervator® NS252, Fisher and Pajkel Healthcare Electronics Ltd, Auckland, New Zealand). Attainment of sensory block was indicated by the lack of crying, flexure of the upper extremities and an increase in both the heart and respiratory rate by 15% above baseline.
Bradycardia is defined as less than 100 bpm, and hypoxia is defined as O2 saturation of less than 95 % for more than 30 seconds. An increase in blood pressure and heart rate of more than 15% above the baseline considered clinically significant.
All the surgical pyloromyotomy procedures were performed by the same paediatric surgeon group, using open Fredet-Ramstedt technique through a supraumbilical transverse right upper quadrant incision. For inadequate relaxation or if persistent discomfort was noticed, infants who were given a single dose bolus of IV Diprivan, (0.5-1 mg.kg-1), or a titration dose of midazolam (0.05-0.1 mg.kg-1).
Intra-operatively, the infants were hydrated with 5% dextrose in a 0.45% NaCl solution at a rate of 5 ml.kg-1.h-1 using an infusion pump.
Statistical analysis:
For the demographic continuous variables (age, weight and height at surgery) and the surgical continuous variables (duration of surgery, duration of spinal anesthesia, total time in operating room, regain of full feeding time and home discharge day) means, standard deviations, medians, ranges and IQR (the difference between Q3 and Q1) will be calculated.
For the categorical variables (number of spinal attempts and sedation required), numbers and percentages will be calculated.
For the continuous repeated measures of respiratory rate, oxygen saturation rates, mean blood pressure and heart rate at six periods of times, the means and standard deviations were calculated, and the results analyzed by the Anova repeated-measures test.
All statistical tests analyzed to a significance level of 0.05. Statistical analysis performed using the STATA 12.0 software.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | – | Device: Spinal anesthesiaLumbar 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. |
| General anesthesia | – | Device: General anesthesiaThe 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. |
Who may qualify
- Ages
- 4 to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with HPS, treated by open pyloromyotomy under Spinal Anesthesia in our medical center
Key inclusion criteria (1 listed)
- Children well hydrated: a normal serum electrolyte count;
Key exclusion criteria (1 listed)
- Children who's spinal puncture was unsuccessful even after a third attempt.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesiaPyloromyotomy under spinal anesthesia | Device | Spinal anesthesia |
| General anesthesiaPyloromyotomy under general anesthesia | Device | General anesthesia |
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
1 secondary outcome
Number of substantial vomiting
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Somri, Prof principal investigator
Bnai Zion Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Pyloric Stenosis and Spinal Anesthesia, run by Bnai Zion Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Somri, Prof (# 972-4-8359304 ext. 9304, mostafa.somri@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total operating room time (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.