ObesityNCT01946763
Does Pre-operative Patients' Education Facilitates Emergence of Anesthesia Following Bariatric Surgery?
A study testing pre operative education in people with Obesity, run by Procare Riaya Hospital at 1 site in Saudi Arabia.
Trial summary
The recovery and emergences from anesthesia is a critical phase. Previous studies focused on pharmological and anesthetics techniques to improve the quality of this stage (duration, complications). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity
- What is being tested?
- pre operative education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jun 2013to May 2014
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults more than 18 years old.
- ASA 2.
- BMI more than 35.
- scheduled for laparoscopic sleeve gastrectomy or gastric bypass surgery.
Who cannot join
- Renal impairment.
- Hepatic dysfunction.
- Alcohol or drug abuse.
- Disabling Central nervous or cerebrovascular diseases.
- Treatment with opioids or any psychoactive medication.
- Inappropriate Mini mental state exam.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Procare Riaya Hospital
Khobar, Eastern Province, 31952
Kamal Abdulkhaleq, MD, +96638955900 ext. 1140, kamal.abdulkhaleq@procare.com.sa
Ahed Zeidane, MD
About this study
The recovery and emergences from anesthesia is a critical phase. Previous studies focused on pharmological and anesthetics techniques to improve the quality of this stage (duration, complications).
In this study, our first aim is to test the impact of pre operative education on the post operative recovery for morbidly obese patient underwent laparoscopic bariatric surgery.
Read the detailed description
The purpose of our study is to compare post operative immediate recovery and emergence for educated and non educated morbidly obese patients underwent laparoscopic bariatric surgery.
Elligibles patients are informed and consented by anesthesiologist. Patients are randomized in 2 groups (G1: educated, G2:non-educated) Patient of G1 are educated in OR before starting anesthesia. This education includes : information about anesthesia emergence, recovery and extubation.
Anesthesia and education are conducted by the same anesthesiologist. All patients are operated by the same surgeon. All patients receive same balanced general anesthesia protocol. The recovery starts immediately after the end of the procedure, when the patient has BIS ≥90 and TOF≥9.
Recovery assessment and data recording is done by a blinded anesthesiologist.
- Conditions
- Obesity
- Being tested
- pre operative education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre operative educationBehavioural
Patients will be randomized in 2 groups (G1: educated, G2:non-educated) In the operating room and before starting anesthesia G1 will receive a pre operative education about anesthesia emergence, recovery and extubation.
pre operative educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| safety of Anesthesia | No intervention | No pre operative education |
| Behavioral : pre operative education | Experimental | Behavioral pre operative education Receives: Behavioral: pre operative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of anesthesia recovery
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Procare Riaya Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahed ZEIDAN, Procare Riaya Hospital
- Investigators
- Ahed Zeidane, MD, Principal investigator, Procare Riaya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946763
- Sponsor's protocol ID
- PRH06
- Status last verified
- Sep 2013
- First submitted
- 3 Jun 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pre-operative Patients' Education Facilitates Emergence of Anesthesia Following Bariatric Surgery?
- ClinicalTrials.gov ID
- NCT01946763
- Acronym / sponsor ID
- PRH06
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Procare Riaya HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 20 Sep 2013 (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 recovery and emergences from anesthesia is a critical phase. Previous studies focused on pharmological and anesthetics techniques to improve the quality of this stage (duration, complications).
In this study, our first aim is to test the impact of pre operative education on the post operative recovery for morbidly obese patient underwent laparoscopic bariatric surgery.
Detailed description
The purpose of our study is to compare post operative immediate recovery and emergence for educated and non educated morbidly obese patients underwent laparoscopic bariatric surgery.
Elligibles patients are informed and consented by anesthesiologist. Patients are randomized in 2 groups (G1: educated, G2:non-educated) Patient of G1 are educated in OR before starting anesthesia. This education includes : information about anesthesia emergence, recovery and extubation.
Anesthesia and education are conducted by the same anesthesiologist. All patients are operated by the same surgeon. All patients receive same balanced general anesthesia protocol. The recovery starts immediately after the end of the procedure, when the patient has BIS ≥90 and TOF≥9.
Recovery assessment and data recording is done by a blinded anesthesiologist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| safety of Anesthesia | No intervention | –No pre operative education |
| Behavioral : pre operative education | Experimental | Behavioral: pre operative educationBehavioral pre operative education |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults more than 18 years old.
- ASA 2.
- BMI more than 35.
- scheduled for laparoscopic sleeve gastrectomy or gastric bypass surgery.
Key exclusion criteria (6 listed)
- Renal impairment.
- Hepatic dysfunction.
- Alcohol or drug abuse.
- Disabling Central nervous or cerebrovascular diseases.
- Treatment with opioids or any psychoactive medication.
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 |
|---|---|---|
| pre operative educationPatients will be randomized in 2 groups (G1: educated, G2:non-educated) In the operating room and before starting anesthesia G1 will receive a pre operative education about anesthesia emergence, recovery and extubation. | Behavioural | Behavioral : pre operative education |
| pre operative education | Behavioural | Behavioral : pre operative education |
Primary outcome
Quality of anesthesia recovery
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
Ahed Zeidane, MD principal investigator
Procare Riaya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre operative education in people with Obesity, run by Procare Riaya Hospital at 1 site in Saudi Arabia.
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 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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. 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 Saudi Arabia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of anesthesia recovery (time frame: 6 hours). 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 20 Sep 2013.