Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort (I-DRINC)

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

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.

Study Overview

• Status: Completed
• Conditions: Scheduled General Anaesthesia With Airway Control
• Intervention / Treatment: Procedure: Early oral fluid recovery.; Procedure: Delayed oral fluid recovery.

• Study Type: Interventional
• Enrollment (Actual): 1555
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vienne
    • Poitiers, Vienne, France, 86000
      • University Hospital of Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early oral fluid recovery.	Procedure: Early oral fluid recovery.
Active Comparator: Delayed oral fluid recovery.	Procedure: Delayed oral fluid recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: I-DRINC