Back to resultsEffects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort (I-DRINC)
Primary Purpose
Scheduled General Anaesthesia With Airway Control
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early oral fluid recovery.
Delayed oral fluid recovery.
Sponsored by
About this trial
This is an interventional prevention trial for Scheduled General Anaesthesia With Airway Control
Eligibility Criteria
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
Sites / Locations
- University Hospital of Poitiers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early oral fluid recovery.
Delayed oral fluid recovery.
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02193737
First Posted
May 21, 2014
Last Updated
April 10, 2020
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02193737
Brief Title
Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort
Acronym
I-DRINC
Official Title
Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 13, 2014 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scheduled General Anaesthesia With Airway Control
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1555 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early oral fluid recovery.
Arm Type
Experimental
Arm Title
Delayed oral fluid recovery.
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Early oral fluid recovery.
Intervention Type
Procedure
Intervention Name(s)
Delayed oral fluid recovery.
Primary Outcome Measure Information:
Title
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.
Description
During first swallowing, patients will be observed to establish if cough occurs during this first swallowing.
Time Frame
1min
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital of Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort
We'll reach out to this number within 24 hrs