Procedural SedationNCT07168135
Effect of Discontinuing Propofol After Cecal Intubation on Patient's Psychomotor Recovery Following Colonoscopy
A study testing propofol (drug) in people with Procedural Sedation and Colonoscopy, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
This study investigates whether discontinuing the continuous intravenous infusion of propofol immediately after cecal intubation would reduce the patient's recovery time without compromising their comfort or convenience. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Sedation, Colonoscopy, Cecal Intubation Success Rate
- What is being tested?
- propofol (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 19 May 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Scheduled ambulatory elective screening or surveillance colonoscopy under MAC.
Who cannot join
- Medical contraindication to anesthesia (i.e., respiratory/cardiac/neurologic compromise, known allergy or adverse reaction to propofol, midazolam, lidocaine, or opiates, …)
- History of ischemic or hemorrhagic cerebrovascular accident.
- Baseline cognitive dysfunction (impaired memory, attention deficit, language disorders, …) - in other words, any dysfunction that prevents the subject from understanding the study protocol and/or completing the requested tests and assessments (e.g., playing the minigames, …)
- Use of more than one psychoactive drug.
- History of partial colectomy.
- Unable to give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Discontinuing Propofol Anesthesia After Cecal Intubation on Patient's Psychomotor Recovery Following Colonoscopy: A Prospective Two-Arm Parallel Randomized Double-Blind Interventional Controlled Trial
This study investigates whether discontinuing the continuous intravenous infusion of propofol immediately after cecal intubation would reduce the patient's recovery time without compromising their comfort or convenience. It would also reduce procedural costs and the risk of medical hazards due to potentially excessive sedation.
Read the detailed description
Colonoscopy is usually conducted after inducing depression in the patient's level of consciousness through sedation, ranging from minimal anxiolysis to general anesthesia, to establish relief from potential anxiety, discomfort, and pain during the procedure; in addition to diminishing the patient's memory of the event and minimizing the risk of adverse events related to agitation. It is traditionally done under endoscopist-directed conscious sedation via the administration of a benzodiazepine and a narcotic. However, anesthesia-assisted sedation has significantly risen for the last decade using almost exclusively propofol continuous intravenous drip, with propofol being a non-analgesic sedating agent marked by its rapid distribution and elimination and stronger sedating effect than the standard regimen, leading to faster induction and recovery from sedation and higher physician and patient satisfaction rates. Several anesthesia techniques were also introduced to ease the visceral pain associated with colonoscopy, such as intravenous lidocaine infusion, low-dose intravenous ketamine, and inhalation of an anesthetic mixture of oxygen with nitrous oxide.
Nevertheless, procedural sedation can induce mild cognitive decline after seemingly full recovery. Padmanabhan and colleagues report a significant decrease in visual attention and psychomotor function from baseline after sedation for colonoscopy. It is recommended by the guidelines for conscious sedation and monitoring during gastrointestinal endoscopy (ASGE, 2003) and the Institute Review of Endoscopic Sedation (AGA, 2008) that patients should be accompanied home by a responsible individual after endoscopic sedation, in addition to be instructed to avoid driving, make legally binding decisions, or operate heavy or potentially harmful machinery. The investigators have recently shown that an important proportion of patients experience periods of general anesthesia and/or a deep hypnotic state during endoscopy.
Prolonged systemic anesthesia is noted to increase the risk for serious complications in colonoscopy patients, either hemodynamically or psychomotorly. Additionally, Wernli and colleagues showed that the overall risk of complications after colonoscopy within 30 days increases when individuals receive anesthesia services, namely, the increased risk of perforation, abdominal pain, and stroke. Thus, minimizing the time systemic anesthesia is administered to the patient as possible during the procedure will likely reduce its potential side effects.
The withdrawal time following cecal intubation is quite controversial and operator-dependent. However, it is recommended to be between 6 and 9 minutes. Thus, withholding anesthetic agents during this phase might be beneficial. It would reduce the patient's exposure to anesthesia without causing any significant under-sedation until the near end of the procedure. At the same time, this intervention may accelerate the patient's post-procedure psychomotor recovery by terminating systemic sedation at an earlier checkpoint. Moreover, Adenoma detection rate (ADR), which refers to the rate of detecting colonic adenomas, is typically assessed during the withdrawal of the scope after cecal intubation. It is well known that this rate is influenced by the withdrawal time, meaning the duration the colonoscopist spends withdrawing the scope from the patient. Early discontinuation of anesthesia could limit the time available for the colonoscopist to detect adenomas during withdrawal, making it a significant outcome to evaluate after each colonoscopy.
This study explores whether discontinuing the continuous intravenous infusion of propofol directly following cecal intubation would shorten the patient's recovery time without affecting his comfort or convenience. It would also reduce procedural costs and the risk of medical hazards due to potentially excessive sedation.
- Conditions
- Procedural Sedation, Colonoscopy, Cecal Intubation Success Rate, Propofol Adverse Reaction
- Being tested
- propofol (drug)
- Keywords
- Cecal intubation, Psychomotor recovery, Procedural sedation, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol (drug)Drug
Withholding the continuous propofol intravenous drip upon intubating the cecum during the colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Propofol withdrawal arm | Experimental | This group will undergo withholding of the propofol sedation upon intubating the cecum during the colonoscopy. Receives: Drug: propofol (drug) |
| Propofol continuation arm | No intervention | This group will not undergo propofol sedation stoppage upon intubating the cecum during the colonoscopy, and will continue receiving continuous intravenous propofol until the full withdrawal of the colonoscope. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to psychomotor recovery after the completion of the colonoscopy
Measured: From enrollment until 24 hours after finishing the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start19 May 2025
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Procedural SedationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168135
- Sponsor's protocol ID
- BIO-2024-0344
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 41646987Bou Daher H, El Mokahal A, Ibrahim MA, Yamout R, Hochaimi N, Ayoub C, Shaib YH, Sharara AI. General anesthesia and/or deep hypnotic state in propofol-based conscious sedation for endoscopy. IGIE. 2024 May 4;3(2):286-292. doi: 10.1016/j.igie.2024.04.017. eCollection 2024 Jun.
PubMed 41647084ASGE Standards of Practice Committee; Early DS, Lightdale JR, Vargo JJ 2nd, Acosta RD, Chandrasekhara V, Chathadi KV, Evans JA, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Muthusamy VR, Pasha SF, Saltzman JR, Shergill AK, Cash BD, DeWitt JM. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2018 Feb;87(2):327-337. doi: 10.1016/j.gie.2017.07.018. Epub 2018 Jan 3. No abstract available.
PubMed 29306520
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Discontinuing Propofol Anesthesia After Cecal Intubation on Patient's Psychomotor Recovery Following Colonoscopy: A Prospective Two-Arm Parallel Randomized Double-Blind Interventional Controlled Trial
- ClinicalTrials.gov ID
- NCT07168135
- Acronym / sponsor ID
- BIO-2024-0344
- Conditions
- Procedural Sedation, Colonoscopy, Cecal Intubation Success Rate, Propofol Adverse Reaction
- Keywords
- Cecal intubation, Psychomotor recovery, Procedural sedation, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Sep 2025 (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.
This study investigates whether discontinuing the continuous intravenous infusion of propofol immediately after cecal intubation would reduce the patient's recovery time without compromising their comfort or convenience. It would also reduce procedural costs and the risk of medical hazards due to potentially excessive sedation.
Detailed description
Colonoscopy is usually conducted after inducing depression in the patient's level of consciousness through sedation, ranging from minimal anxiolysis to general anesthesia, to establish relief from potential anxiety, discomfort, and pain during the procedure; in addition to diminishing the patient's memory of the event and minimizing the risk of adverse events related to agitation. It is traditionally done under endoscopist-directed conscious sedation via the administration of a benzodiazepine and a narcotic. However, anesthesia-assisted sedation has significantly risen for the last decade using almost exclusively propofol continuous intravenous drip, with propofol being a non-analgesic sedating agent marked by its rapid distribution and elimination and stronger sedating effect than the standard regimen, leading to faster induction and recovery from sedation and higher physician and patient satisfaction rates. Several anesthesia techniques were also introduced to ease the visceral pain associated with colonoscopy, such as intravenous lidocaine infusion, low-dose intravenous ketamine, and inhalation of an anesthetic mixture of oxygen with nitrous oxide.
Nevertheless, procedural sedation can induce mild cognitive decline after seemingly full recovery. Padmanabhan and colleagues report a significant decrease in visual attention and psychomotor function from baseline after sedation for colonoscopy. It is recommended by the guidelines for conscious sedation and monitoring during gastrointestinal endoscopy (ASGE, 2003) and the Institute Review of Endoscopic Sedation (AGA, 2008) that patients should be accompanied home by a responsible individual after endoscopic sedation, in addition to be instructed to avoid driving, make legally binding decisions, or operate heavy or potentially harmful machinery. The investigators have recently shown that an important proportion of patients experience periods of general anesthesia and/or a deep hypnotic state during endoscopy.
Prolonged systemic anesthesia is noted to increase the risk for serious complications in colonoscopy patients, either hemodynamically or psychomotorly. Additionally, Wernli and colleagues showed that the overall risk of complications after colonoscopy within 30 days increases when individuals receive anesthesia services, namely, the increased risk of perforation, abdominal pain, and stroke. Thus, minimizing the time systemic anesthesia is administered to the patient as possible during the procedure will likely reduce its potential side effects.
The withdrawal time following cecal intubation is quite controversial and operator-dependent. However, it is recommended to be between 6 and 9 minutes. Thus, withholding anesthetic agents during this phase might be beneficial. It would reduce the patient's exposure to anesthesia without causing any significant under-sedation until the near end of the procedure. At the same time, this intervention may accelerate the patient's post-procedure psychomotor recovery by terminating systemic sedation at an earlier checkpoint. Moreover, Adenoma detection rate (ADR), which refers to the rate of detecting colonic adenomas, is typically assessed during the withdrawal of the scope after cecal intubation. It is well known that this rate is influenced by the withdrawal time, meaning the duration the colonoscopist spends withdrawing the scope from the patient. Early discontinuation of anesthesia could limit the time available for the colonoscopist to detect adenomas during withdrawal, making it a significant outcome to evaluate after each colonoscopy.
This study explores whether discontinuing the continuous intravenous infusion of propofol directly following cecal intubation would shorten the patient's recovery time without affecting his comfort or convenience. It would also reduce procedural costs and the risk of medical hazards due to potentially excessive sedation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol withdrawal arm | Experimental | Drug: propofol (drug)This group will undergo withholding of the propofol sedation upon intubating the cecum during the colonoscopy. |
| Propofol continuation arm | No intervention | –This group will not undergo propofol sedation stoppage upon intubating the cecum during the colonoscopy, and will continue receiving continuous intravenous propofol until the full withdrawal of the colonoscope. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 80 years.
- Scheduled ambulatory elective screening or surveillance colonoscopy under MAC.
Key exclusion criteria (6 listed)
- Medical contraindication to anesthesia (i.e., respiratory/cardiac/neurologic compromise, known allergy or adverse reaction to propofol, midazolam, lidocaine, or opiates, …)
- History of ischemic or hemorrhagic cerebrovascular accident.
- Baseline cognitive dysfunction (impaired memory, attention deficit, language disorders, …) - in other words, any dysfunction that prevents the subject from understanding the study protocol and/or completing the requested tests and assessments (e.g., playing the minigames, …)
- Use of more than one psychoactive drug.
- History of partial colectomy.
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 |
|---|---|---|
| propofol (drug)Withholding the continuous propofol intravenous drip upon intubating the cecum during the colonoscopy. | Drug | Propofol withdrawal arm |
Primary outcome
Time to psychomotor recovery after the completion of the colonoscopy
Time frame: From enrollment until 24 hours after finishing the colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: 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.
- Background: PubMed 41647084Bou Daher H, El Mokahal A, Ibrahim MA, Yamout R, Hochaimi N, Ayoub C, Shaib YH, Sharara AI. General anesthesia and/or deep hypnotic state in propofol-based conscious sedation for endoscopy. IGIE. 2024 May 4;3(2):286-292. doi: 10.1016/j.igie.2024.04.017. eCollection 2024 Jun.
- Background: PubMed 29306520ASGE Standards of Practice Committee; Early DS, Lightdale JR, Vargo JJ 2nd, Acosta RD, Chandrasekhara V, Chathadi KV, Evans JA, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Muthusamy VR, Pasha SF, Saltzman JR, Shergill AK, Cash BD, DeWitt JM. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2018 Feb;87(2):327-337. doi: 10.1016/j.gie.2017.07.018. Epub 2018 Jan 3. No abstract available.
- 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.
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 propofol (drug) in people with Procedural Sedation and Colonoscopy, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to psychomotor recovery after the completion of the colonoscopy (time frame: From enrollment until 24 hours after finishing the colonoscopy). 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 NCT07168135, which also lists 3 linked publications.
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 11 Sep 2025.