Gastric pH in Intubated Children

Preoperative Fasting Clinical Trial

Official title:

Untersuchung Des Magen-pH in Intubationsanästhesie Bei Kindern

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516775
• Other study ID #: KEK-ZH Nr. 2011-0034
• Status: Completed
• Phase: N/A
• First received: January 16, 2012
• Last updated: September 28, 2012
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Preoperative Fasting

Intervention

Other:
• clear fluid ingestion
drinking of clear fluid in preoperative period

Locations

Country	Name	City	State
Switzerland	University Children's Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Achim Schmitz

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gastric pH	gastric 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	within 10 min after tracheal intubation	No
Secondary	subjective feeling of hunger/thirst	subjective feeling of hunger/thirst given as rating scale from 1 to 4	within 10 minutes after arrival of patient in operating theatre	No
Secondary	gastric aspirate volume	gastric 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	within 10 min after tracheal intubation	No
Secondary	Postoperative Nausea and Vomiting (PONV) in recovery unit		recovery period, on the average within 90 minutes after end of anaesthesia	No
Secondary	Behaviour during recovery period	Rating 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)	recovery period, on the average within 90 minutes after end of anaesthesia	No
Secondary	Behaviour during anaesthesia induction	Rating scale 1 - 5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting	on the average within 20 minutes after arrival of patient in operating theatre	No