Skip to content

Gastric pH in Intubated Children - Part Two

Untersuchung Des Magen-pH in lntubationsanästhesie Bei Kindern - Teil Zwei

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02603094
Enrollment
180
Registered
2015-11-11
Start date
2015-12-31
Completion date
2016-08-31
Last updated
2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative Fasting

Brief summary

Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children undergoing elective procedures in general anaesthesia and intubation without inconvenience or additional invasive procedure and hence without additional risk Hypotheses: Gastric pH is higher in children that drink clear fluids until premedication before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction

Interventions

drinking of clear fluid in preoperative period

Sponsors

University Children's Hospital, Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

age \> 1 / \< 16 years ASA class l or ll elective surgery requiring general anaesthesia using tracheal intubation

Exclusion criteria

disease or dysfunction of gastrointestinal tract chronic diseases or conditions not compatible with ASA class l or ll

Design outcomes

Primary

MeasureTime frameDescription
gastric pHwithin 10 min after tracheal intubationgastric pH is measured from gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution

Secondary

MeasureTime frameDescription
subjective feeling of hunger/thirstbaselinesubjective feeling of hunger/thirst given as yes or no answer
Postoperative Nausea and Vomiting (PONV) in recovery unitrecovery period, on the average within 90 minutes after end of anaesthesia
Behaviour during recovery periodrecovery period, on the average within 90 minutes after end of anaesthesiaRating Scale1-5 by blinded nurse (5: severely agitated/emergence delir with subsequent drug therapy, 4: agitated/emergence delir; 3: slightly agitated; 2: complaining pain but cooperative; 1: cooperative)
gastric aspirate volumewithin 10 min after tracheal intubationgastric aspirate volume is the amount of gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution
Nurse's Impression of patient's satisfactorybaselinesubjective feeling of the Nurse regarding patient's satisfactory given as rating scale from 1 to 4
blood Ketone measurementintraoperativemeasurement of blood Ketone with a portable poc Ketone measurement device
Behaviour during anaesthesia inductionon the average within 20 minutes after arrival of patient in operating theatreRating scale1-5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026