Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort

Scheduled General Anaesthesia With Airway Control Clinical Trial

— I-DRINC  

Official title:

Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193737
• Other study ID #: I-DRINC
• Status: Completed
• Phase: N/A
• Start date: May 13, 2014
• Est. completion date: September 1, 2016

Study information

• Verified date: March 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

National guidelines about post-operative fasting after general anesthesia are missing.

Current clinical practices are highly variable and no study has ever evaluated on a large scale the real risk of an early drinks recovery in postoperative period.

The aim of this study is to state the impact of early drinks recovery after general anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1555
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled surgery

• General anaesthesia with laryngeal mask or endotracheal intubation.

• Length of surgery < 4 hours

Exclusion Criteria:

• Emergency surgery

• Intra-cranial, cervical or Ear, Nose and Throat surgery

• Guts surgery with guts anastomosis.

• Glottic topical anesthesia

• Patient with nasogastric tube

• Aspiration during surgery or during PACU stay

Related Conditions & MeSH terms

• Scheduled General Anaesthesia With Airway Control
• Vomiting

Intervention

Procedure:
• Early oral fluid recovery.

• Delayed oral fluid recovery.

Locations

Country	Name	City	State
France	University Hospital of Poitiers	Poitiers	Vienne

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if early oral fluid recovery after an elective surgery under general anaesthesia with endotracheal intubation or laryngeal mask increasethe incidence of cough during swallowing, ie aspiration.	During first swallowing, patients will be observed to establish if cough occurs during this first swallowing.	1min
Secondary	To determine if early oral fluid recovery (i.e patient discharged of PACU) after general anaesthesia increases post-operative vomiting during first hour and patient comfort rated on a 10 points scale.	During a one-hour period after first swallowing, patients will be looked after for any vomiting.; At the end of day, patients will be asked to rate their postoperative comfort on a 10 points scale.	1 hour