Delayed Emergence From AnesthesiaNCT02101671
Inadequate Emergence After Laparoscopic Surgery in Trendelemburg Position
An observational study of Delayed Emergence From Anesthesia and Delirium, Cause Unknown, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The purpose of this study is to determinate if the patients submitted to laparoscopic surgery in trendelemburg position develope more inadequate anaesthesic emergence than patients submitted to laparoscopic surgery in other positions. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Delayed Emergence From Anesthesia, Delirium, Cause Unknown, Confusion
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Dec 2014
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient undergone surgery
Who may be able to join
- laparoscopic surgery
- general anaesthesia
- trendelemburg positioning
- extubated in the operatory theater
Who cannot join
- unable of communicate
- dementia
- psychiatric history
- neurosurgery
- alchohol and drugs addictions
Trial locations and contacts
1 site in 1 country.
Spain1 site
Anaesthesia and Reanimation Department, Hospital Parc Tauli
Sabadell, Barcelona, 08208
About this study
Official title: Inadequate Emergence After Anaesthesia in Laparoscopic Surgery in Trendelemburg Position
The purpose of this study is to determinate if the patients submitted to laparoscopic surgery in trendelemburg position develope more inadequate anaesthesic emergence than patients submitted to laparoscopic surgery in other positions.
- Conditions
- Delayed Emergence From Anesthesia, Delirium, Cause Unknown, Confusion, Disorientation on Emergence
- Keywords
- agitation, anaesthesia, laparoscopy, surgery, delirium, sedation, emergence, steep, trendelemburg, position, delayed, Confusion, Disorientation
- Medical subject headings
- Delayed Emergence from Anesthesia, Delirium, Confusion, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| trendelemburg positioning | Patients undergone laparoscopic surgery in trendelemburg position | |
| Not trendelemburg positioning | Patients undergone laparoscopic surgery not in trendelemburg position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadequate emergence after anaesthesia
The inadequate emergence after anaesthesia will be evalueted with the Richmond Agitation Sedation Scale, defining as inadequate emergence a punctuation >= +1 (delirium form) and <=-2 (hypoactive form).
Measured: 10 minutes after the arrival of the patient in the postsurgical unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Emergence From AnesthesiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morena Basso, Corporacion Parc Tauli
- Investigators
- Morena Basso, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101671
- Sponsor's protocol ID
- 2014/522
- Status last verified
- Mar 2014
- First submitted
- 29 Mar 2014
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inadequate Emergence After Anaesthesia in Laparoscopic Surgery in Trendelemburg Position
- ClinicalTrials.gov ID
- NCT02101671
- Acronym / sponsor ID
- 2014/522
- Conditions
- Delayed Emergence From Anesthesia, Delirium, Cause Unknown, Confusion, Disorientation on Emergence
- Keywords
- agitation, anaesthesia, laparoscopy, surgery, delirium, sedation, emergence, steep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 2 Apr 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.
The purpose of this study is to determinate if the patients submitted to laparoscopic surgery in trendelemburg position develope more inadequate anaesthesic emergence than patients submitted to laparoscopic surgery in other positions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trendelemburg positioning | – | –Patients undergone laparoscopic surgery in trendelemburg position |
| Not trendelemburg positioning | – | –Patients undergone laparoscopic surgery not in trendelemburg position |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient undergone surgery
Key inclusion criteria (4 listed)
- laparoscopic surgery
- general anaesthesia
- trendelemburg positioning
- extubated in the operatory theater
Key exclusion criteria (5 listed)
- unable of communicate
- dementia
- psychiatric history
- neurosurgery
- alchohol and drugs addictions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inadequate emergence after anaesthesia
Time frame: 10 minutes after the arrival of the patient in the postsurgical unit
The inadequate emergence after anaesthesia will be evalueted with the Richmond Agitation Sedation Scale, defining as inadequate emergence a punctuation >= +1 (delirium form) and <=-2 (hypoactive form).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
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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.
Morena Basso principal investigator
Corporacion Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delayed Emergence From Anesthesia and Delirium, Cause Unknown, run by Corporacion Parc Tauli at 1 site in Spain.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Apr 2014. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morena Basso (00937231010, morena.basso@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inadequate emergence after anaesthesia (time frame: 10 minutes after the arrival of the patient in the postsurgical unit). 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 2 Apr 2014.