Scheduled General Anaesthesia With Airway ControlI-DRINCNCT02193737
Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort
A study testing Early oral fluid recovery. and Delayed oral fluid recovery. in people with Scheduled General Anaesthesia With Airway Control, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scheduled General Anaesthesia With Airway Control
- What is being tested?
- Early oral fluid recovery. and Delayed oral fluid recovery.
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,555 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2014to 1 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Scheduled surgery
- General anaesthesia with laryngeal mask or endotracheal intubation.
- Length of surgery < 4 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Early oral fluid recovery., Delayed oral fluid recovery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early oral fluid recovery.Procedure or surgery
Delayed oral fluid recovery.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Early oral fluid recovery. | Experimental | Not described Receives: Procedure: Early oral fluid recovery. |
| Delayed oral fluid recovery. | Active comparator | Not described Receives: Procedure: Delayed oral fluid recovery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1min
Secondary outcomes (1)
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study start13 May 2014
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scheduled General Anaesthesia With Airway ControlStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193737
- Sponsor's protocol ID
- I-DRINC
- Acronym
- I-DRINC
- Status last verified
- Mar 2020
- First submitted
- 21 May 2014
- Last updated
- 14 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort.
- ClinicalTrials.gov ID
- NCT02193737
- Acronym / sponsor ID
- I-DRINC / I-DRINC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,555 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 13 May 2014 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early oral fluid recovery. | Experimental | Procedure: Early oral fluid recovery. |
| Delayed oral fluid recovery. | Active comparator | Procedure: Delayed oral fluid recovery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled surgery
- General anaesthesia with laryngeal mask or endotracheal intubation.
- Length of surgery < 4 hours
Key exclusion criteria (6 listed)
- Emergency surgery
- Intra-cranial, cervical or Ear, Nose and Throat surgery
- Guts surgery with guts anastomosis.
- Glottic topical anesthesia
- Patient with nasogastric tube
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early oral fluid recovery. | Procedure or surgery | Early oral fluid recovery. |
| Delayed oral fluid recovery. | Procedure or surgery | Delayed oral fluid recovery. |
Primary outcome
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.
Time frame: 1min
During first swallowing, patients will be observed to establish if cough occurs during this first swallowing.
1 secondary outcome
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.
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early oral fluid recovery. and Delayed oral fluid recovery. in people with Scheduled General Anaesthesia With Airway Control, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.