Anesthesia, RecoveryRECoVERNCT04096339
Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First
A study testing Colonoscopy followed by EGD and EGD followed by Colonoscopy in people with Anesthesia, Recovery, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The purpose of this research is to compare the effect of different procedural sequences on the time to recovery and the propofol sedation requirements in patients undergoing bidirectional endoscopy with sedation. The two sequences are: Colonoscopy followed by Esophagogastroduodenoscopy (EGD) EGD followed by Colonoscopy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Recovery
- What is being tested?
- Colonoscopy followed by EGD and EGD followed by Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteLebanon
- Study dates
- 3 Jul 2019to 30 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18
- Scheduled EGD and colonoscopy on the same day
- Scheduled to Anaesthesiologist administered sedation during the procedure
Who cannot join
- Age below 18
- Known allergy or adverse reaction to Propofol, Midazolam or opioid medication (ex: fentanyl)
- Medical contraindication to Anaesthesia
- Sleep apnea
- American Society of Anesthesiologists classification (ASA) >3
- Inpatient status
Show all 20Show fewer
- Pregnant or lactating women
- Known cirrhosis
- Chronic Kidney Disease (stage 4 or 5)
- Known psychological disorder
- Known cognitive dysfunction
- Significant gastroparesis
- Gastric outlet obstruction
- Ileus
- Known or suspected bowel obstruction or perforation
- Having a stoma
- Compromised swallowing reflex or mental status
- Prior colon resection or gastric surgery
- Age above 75 years
- Chronic use of more than 1 psychoactive drug (Benzodiazepines, Tricyclic antidepressants, antipsychotics, selective serotonin receptor inhibitors, serotonin norepinephrine receptor inhibitors, Monoamine oxidase inhibitor)
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut - Medical Center
Beirut
Ala' I. Sharara, MD, 009611350000 ext. 5345, as08@aub.edu.lb
Ala' I Sharara, MD
About this study
Official title: RECoVER: Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First
The purpose of this research is to compare the effect of different procedural sequences on the time to recovery and the propofol sedation requirements in patients undergoing bidirectional endoscopy with sedation.
The two sequences are:
- Colonoscopy followed by Esophagogastroduodenoscopy (EGD)
- EGD followed by Colonoscopy
Read the detailed description
120 patients will be asked to participate in the trial. The subject will undergo both procedures in the order assigned by the randomization sheet. During the procedure, the endoscopist and anesthesiologists will collect data including but not limited to vital signs (heart rate, blood oxygen level, blood pressure) and level of sedation through the Bispectral Index Monitor (BIS). After completing the procedures, the patient will be approached in the recovery room by the study coordinator who will administer the Modified Post Anesthesia Discharge Scoring System (M-PADSS) scale every 5 minutes until a score of 9 or higher is obtained on two consecutive attempts. 24 hours following the procedure, the study coordinator will call the patient in order to assess the patient's cognitive function and drowsiness after they were discharged from the endoscopy unit.
- Conditions
- Anesthesia, Recovery
- Being tested
- Colonoscopy followed by EGD, EGD followed by Colonoscopy
- Keywords
- Colonoscopy, EGD, Sedation, procedural sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy followed by EGDOther
Colonoscopy is done first followed by EGD
EGD followed by ColonoscopyOther
Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| EGD followed by Colonoscopy | Active comparator | Randomized to group Esophagogastroduodenoscopy followed by Colonoscopy Receives: Other: EGD followed by Colonoscopy |
| Colonoscopy followed by EGD | Active comparator | Randomized to group Colonoscopy followed by Esophagogastroduodenoscopy Receives: Other: Colonoscopy followed by EGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge
Time from end of procedures to patient discharge
Measured: 1 hour
Secondary outcomes (4)
Propofol dose
Propofol sedation requirements
Measured: 1 hour
Depth of anesthesia
Bispectral Index (BIS) tracking of depth of anesthesia throughout the two procedures. BIS is a single dimensionless number generated by EEG analysis.
Measured: 1 hour
Cognitive impairment
An assessment of cognitive impairment after the subject emerges from sedation, using the Modified Post Anesthesia Discharge System (M-PADS)
Measured: 24 hours
Adverse events during sedation
apnea, desaturations, hypotension, bradycardia and other hemodynamical disturbances during sedation
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 posted19 Sep 2019
- Study start3 Jul 2019
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, RecoveryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ala'a Sharara, MD, American University of Beirut Medical Center
- Investigators
- Ala I Sharara, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096339
- Sponsor's protocol ID
- BIO-2018-0629
- Acronym
- RECoVER
- Status last verified
- Sep 2019
- First submitted
- 11 Jul 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Mokahal A, Daher HB, Yamout R, Hoshaimi N, Ayoub C, Shaib Y, Sharara AI. Randomized controlled trial of procedural sequence for same-day bidirectional endoscopy under monitored anesthesia care (RECoVER Trial). IGIE. 2023 Jul 25;2(3):282-291. doi: 10.1016/j.igie.2023.07.014. eCollection 2023 Sep.
PubMed 41646987
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECoVER: Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First
- ClinicalTrials.gov ID
- NCT04096339
- Acronym / sponsor ID
- RECoVER / BIO-2018-0629
- Conditions
- Anesthesia, Recovery
- Keywords
- Colonoscopy, EGD, Sedation, procedural sequence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 19 Sep 2019 (actual)
- 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 research is to compare the effect of different procedural sequences on the time to recovery and the propofol sedation requirements in patients undergoing bidirectional endoscopy with sedation.
The two sequences are:
- Colonoscopy followed by Esophagogastroduodenoscopy (EGD)
- EGD followed by Colonoscopy
Detailed description
120 patients will be asked to participate in the trial. The subject will undergo both procedures in the order assigned by the randomization sheet. During the procedure, the endoscopist and anesthesiologists will collect data including but not limited to vital signs (heart rate, blood oxygen level, blood pressure) and level of sedation through the Bispectral Index Monitor (BIS). After completing the procedures, the patient will be approached in the recovery room by the study coordinator who will administer the Modified Post Anesthesia Discharge Scoring System (M-PADSS) scale every 5 minutes until a score of 9 or higher is obtained on two consecutive attempts. 24 hours following the procedure, the study coordinator will call the patient in order to assess the patient's cognitive function and drowsiness after they were discharged from the endoscopy unit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGD followed by Colonoscopy | Active comparator | Other: EGD followed by ColonoscopyRandomized to group Esophagogastroduodenoscopy followed by Colonoscopy |
| Colonoscopy followed by EGD | Active comparator | Other: Colonoscopy followed by EGDRandomized to group Colonoscopy followed by Esophagogastroduodenoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18
- Scheduled EGD and colonoscopy on the same day
- Scheduled to Anaesthesiologist administered sedation during the procedure
Key exclusion criteria (20 listed)
- Age below 18
- Known allergy or adverse reaction to Propofol, Midazolam or opioid medication (ex: fentanyl)
- Medical contraindication to Anaesthesia
- Sleep apnea
- American Society of Anesthesiologists classification (ASA) >3
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 |
|---|---|---|
| Colonoscopy followed by EGDColonoscopy is done first followed by EGD | Other | Colonoscopy followed by EGD |
| EGD followed by ColonoscopyEsophagoduodenoscopy (EGD) is done first followed by Colonoscopy | Other | EGD followed by Colonoscopy |
Primary outcome
Time to discharge
Time frame: 1 hour
Time from end of procedures to patient discharge
4 secondary outcomes
Propofol dose
Time frame: 1 hour
Depth of anesthesia
Time frame: 1 hour
Cognitive impairment
Time frame: 24 hours
Adverse events during sedation
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 41646987El Mokahal A, Daher HB, Yamout R, Hoshaimi N, Ayoub C, Shaib Y, Sharara AI. Randomized controlled trial of procedural sequence for same-day bidirectional endoscopy under monitored anesthesia care (RECoVER Trial). IGIE. 2023 Jul 25;2(3):282-291. doi: 10.1016/j.igie.2023.07.014. eCollection 2023 Sep.
- Individual participant dataSharing planned: No
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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.
Ala I Sharara, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy followed by EGD and EGD followed by Colonoscopy in people with Anesthesia, Recovery, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 20 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 19 Sep 2019. 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 Lebanon. 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 Ala I Sharara, MD (+961-1-350000 ext. 5345, as08@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to discharge (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04096339, which also lists 1 linked publication.
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 19 Sep 2019.