Gastric pH in Intubated Children

Not Applicable

Completed

• Conditions: Preoperative Fasting
• Interventions: Other: clear fluid ingestion

• Registration Number: NCT01516775
• Lead Sponsor: Achim Schmitz

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-28
• Last Update Posted: 2012-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 hour fluid fasting	clear fluid ingestion	allowed to drink until 1 hour before scheduled anaesthesia induction
2 hours fluid fasting	clear fluid ingestion	allowed to drink until 2 hour before scheduled anaesthesia induction

Primary Outcome Measures

Name	Time	Method
gastric pH	within 10 min after tracheal intubation	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

Secondary Outcome Measures

Name	Time	Method
subjective feeling of hunger/thirst	within 10 minutes after arrival of patient in operating theatre	subjective feeling of hunger/thirst given as rating scale from 1 to 4
Behaviour during recovery period	recovery period, on the average within 90 minutes after end of anaesthesia	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)
Behaviour during anaesthesia induction	on the average within 20 minutes after arrival of patient in operating theatre	Rating scale 1 - 5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting
gastric aspirate volume	within 10 min after tracheal intubation	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
Postoperative Nausea and Vomiting (PONV) in recovery unit	recovery period, on the average within 90 minutes after end of anaesthesia

Trial Locations

Locations (1)

University Children's Hospital; 🇨🇭 Zurich, Switzerland