ColonoscopyNCT04906317
The Effectiveness of Sedation and Analgesia in Colonoscopy Treatment of Colorectal Polyps
A study testing midazolam and dezocine and Propofol in people with Colonoscopy and Sedation and Analgesia, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness of sedation and analgesia in the treament of colorectal polyps by colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colonoscopy, Sedation and Analgesia
- What is being tested?
- midazolam and dezocine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 12 Dec 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colonoscopy diagnosed as a colorectal polyp, the number of polyps is less than 5, and the size of single polyp is less than 2.0 cm
- Age more than 18 years and less than 70 years
Who cannot join
- Allergy to propofol, dezocine, midazolam or eggs
- ASA class IV, short and tick neck, difficult intubation due to inability to open the mouth widely
- Suspected of gastrointestinal perforation, bleeding or obstruction
- Acute gastrointestinal infection period
- History of abdominal surgery
- Patients during pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Six Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Jiancong Hu, MD, +86 02038476875, hujianc@mail.sysu.edu.cn
About this study
Official title: The Effectiveness of Sedation and Analgesia in Colonoscopy Treatment of Colorectal Polyps: a Single-center, Prospective, Randomized Controlled Study
This study aims to evaluate the effectiveness of sedation and analgesia in the treament of colorectal polyps by colonoscopy.
Read the detailed description
Colorectal polyps are precancerous lesions of the colorectal cancer. Colonoscopy can reduce the risk of colorectal cancer. Painless endoscopy could reduce patient discomfort and improves the acceptance of treatment, especially for the endoscopic treatment of colorectal polyps. Intravenous anesthesia colonoscopy has a strong sedative effect and has obvious inhibitory effects on the respiratory and circulatory systems. It requires the assistance of an anesthesiologist. The lack of anesthesiologists makes it difficult to make an appointment for anesthesia colonoscopy, which is a bottleneck in the diagnosis and treatment of gastrointestinal diseases in China. Therefore, there is an urgent need to find a painless diagnosis and treatment method that is not inferior to anesthesia colonoscopy in comfort to meet the needs of patients. Comparing to anesthesia colonoscopy, sedative and analgesic colonoscopy have similar sedative and analgesic effects and do not require the assistance of an anesthesiologist. However, there is no relevant evaluation on the effectiveness of sedation and analgesia during the endoscopic treatment of colorectal polyps. Our department has used midazolam combined with dezocine to treat 185 patients with colorectal polyps in these years. Retrospective analysis showed that the sedative and analgesic effect is satisfactory. Therefore, it is necessary to make a single-center randomized parallel group controlled non-inferiority study to directly compare the effectiveness of sedation and analgesia versus intravenous anesthesia in endoscopic treatment of colorectal polyps.
- Conditions
- Colonoscopy, Sedation and Analgesia
- Being tested
- midazolam and dezocine, Propofol
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolam and dezocineDrug
Also called Not necessary
Midazolam (0.05 mg/kg) and dezocine(5mg) sedation during colonoscopy, targeted to a painless level
PropofolDrug
Also called Not necessary
standard propofol (1.5mg/kg) induction during colonoscopy, targeted to a moderate sedation level
| Study group | Role | What they receive |
|---|---|---|
| Sedation and Analgesia | Active comparator | 0.05 mg/kg midazolam and 5mg dezocine iv infusion Receives: Drug: midazolam and dezocine |
| Anesthesia | Active comparator | continuous 1.5mg/kg propofol iv infusion Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of visual analogue scoring (VAS)
Assess immediately after the completement of colonoscopy
Measured: immediately after the procedure of colonoscopy
Secondary outcomes (1)
Treatment fee
The fee of treatment refers to the total cost of anesthesia fee, anesthesia/sedation drug fee, intraoperative monitoring fee, endoscopy fee and endoscopic treatment fee
Measured: During the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Dec 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion12 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuefeng Guo, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906317
- Sponsor's protocol ID
- 2021ZSLYEC-028
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Sedation and Analgesia in Colonoscopy Treatment of Colorectal Polyps: a Single-center, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04906317
- Acronym / sponsor ID
- 2021ZSLYEC-028
- Conditions
- Colonoscopy, Sedation and Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 12 Dec 2024 (estimated)
- First posted
- 28 May 2021 (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 aims to evaluate the effectiveness of sedation and analgesia in the treament of colorectal polyps by colonoscopy.
Detailed description
Colorectal polyps are precancerous lesions of the colorectal cancer. Colonoscopy can reduce the risk of colorectal cancer. Painless endoscopy could reduce patient discomfort and improves the acceptance of treatment, especially for the endoscopic treatment of colorectal polyps. Intravenous anesthesia colonoscopy has a strong sedative effect and has obvious inhibitory effects on the respiratory and circulatory systems. It requires the assistance of an anesthesiologist. The lack of anesthesiologists makes it difficult to make an appointment for anesthesia colonoscopy, which is a bottleneck in the diagnosis and treatment of gastrointestinal diseases in China. Therefore, there is an urgent need to find a painless diagnosis and treatment method that is not inferior to anesthesia colonoscopy in comfort to meet the needs of patients. Comparing to anesthesia colonoscopy, sedative and analgesic colonoscopy have similar sedative and analgesic effects and do not require the assistance of an anesthesiologist. However, there is no relevant evaluation on the effectiveness of sedation and analgesia during the endoscopic treatment of colorectal polyps. Our department has used midazolam combined with dezocine to treat 185 patients with colorectal polyps in these years. Retrospective analysis showed that the sedative and analgesic effect is satisfactory. Therefore, it is necessary to make a single-center randomized parallel group controlled non-inferiority study to directly compare the effectiveness of sedation and analgesia versus intravenous anesthesia in endoscopic treatment of colorectal polyps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation and Analgesia | Active comparator | Drug: midazolam and dezocine0.05 mg/kg midazolam and 5mg dezocine iv infusion |
| Anesthesia | Active comparator | Drug: Propofolcontinuous 1.5mg/kg propofol iv infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Colonoscopy diagnosed as a colorectal polyp, the number of polyps is less than 5, and the size of single polyp is less than 2.0 cm
- Age more than 18 years and less than 70 years
Key exclusion criteria (6 listed)
- Allergy to propofol, dezocine, midazolam or eggs
- ASA class IV, short and tick neck, difficult intubation due to inability to open the mouth widely
- Suspected of gastrointestinal perforation, bleeding or obstruction
- Acute gastrointestinal infection period
- History of abdominal surgery
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 |
|---|---|---|
| midazolam and dezocineAlso: Not necessaryMidazolam (0.05 mg/kg) and dezocine(5mg) sedation during colonoscopy, targeted to a painless level | Drug | Sedation and Analgesia |
| PropofolAlso: Not necessarystandard propofol (1.5mg/kg) induction during colonoscopy, targeted to a moderate sedation level | Drug | Anesthesia |
Primary outcome
The score of visual analogue scoring (VAS)
Time frame: immediately after the procedure of colonoscopy
Assess immediately after the completement of colonoscopy
1 secondary outcome
Treatment fee
Time frame: During the colonoscopy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- 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.
Xuefeng Guo, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midazolam and dezocine and Propofol in people with Colonoscopy and Sedation and Analgesia, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 28 May 2021. 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 China. 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 Jiancong Hu, MD (+86 02038476875, hujianc@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of visual analogue scoring (VAS) (time frame: immediately after the procedure of colonoscopy). 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 28 May 2021.