Skip to content

Gastric pH in Intubated Children

Untersuchung Des Magen-pH in Intubationsanästhesie Bei Kindern

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01516775
Enrollment
150
Registered
2012-01-25
Start date
2012-01-31
Completion date
2012-09-30
Last updated
2012-10-01

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

Conditions

Preoperative Fasting

Keywords

preoperative care, preoperative period, 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 intubation anaesthesia without inconvenience or additional invasive procedure and hence without additional risk Hypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction

Interventions

drinking of clear fluid in preoperative period

Sponsors

Achim Schmitz
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* age \> 1 / \<= 16 years * ASA class I or II * 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 I or II

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
Behaviour during recovery periodrecovery period, on the average within 90 minutes after end of anaesthesiaRating Scale 1 - 5 by blinded nurse (5: severely agitated/emergency delir with subsequent drug therapy, 4: agitated/emergeny delir; 3: slightly agitated; 2: complaining pain but cooperative; 1: cooperative)
subjective feeling of hunger/thirstwithin 10 minutes after arrival of patient in operating theatresubjective feeling of hunger/thirst given as rating scale from 1 to 4
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
Postoperative Nausea and Vomiting (PONV) in recovery unitrecovery period, on the average within 90 minutes after end of anaesthesia
Behaviour during anaesthesia inductionon the average within 20 minutes after arrival of patient in operating theatreRating scale 1 - 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 18, 2026