Colorectal NeoplasmsNCT04516174
Effect of Transversus Abdominis Plane Block Combined With Dexmedetomidine Infusion on the Prognosis in Elderly Patients Undergoing Abdominal Surgery
A study testing Transversus abdominis plane block using ropivacaine, Dexmedetomidine and Transversus abdominis plane block using saline in people with Colorectal Neoplasms and Aged, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To compare the prognosis of elderly patients undergoing radical resection of colorectal cancer treated with general anesthesia and general anesthesia combined with transversus abdominis plane block and continuous infusion of dexmedetomidine. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Colorectal Neoplasms, Aged
- What is being tested?
- Transversus abdominis plane block using ropivacaine, Dexmedetomidine and Transversus abdominis plane block using saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 Sep 2023
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65-80 years,regardless of gender
- American Society of Anesthesiologists physical status I-III
- Undergoing elective radical resection of colorectal cancer
- Sign informed consent
Who cannot join
- Could not cooperate to complete the pain VAS evaluation
- Could not cooperate to complete the cognitive function assessment
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tian Tan Hospital
Beijing, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
About this study
To compare the prognosis of elderly patients undergoing radical resection of colorectal cancer treated with general anesthesia and general anesthesia combined with transversus abdominis plane block and continuous infusion of dexmedetomidine. The incidence of postoperative delirium, postoperative acute pain moderately to severely and poor postoperative recovery were composite endpoints to determine the prognosis of patients.
- Conditions
- Colorectal Neoplasms, Aged
- Being tested
- Transversus abdominis plane block using ropivacaine, Dexmedetomidine, Transversus abdominis plane block using saline, Saline
- Keywords
- Delirium, Pain, Postoperative, Dexmedetomidine, Transversus abdominis plane block
- Medical subject headings
- Colorectal Neoplasms, Delirium, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane block using ropivacaineProcedure or surgery
Before anesthesia, the ultrasound-guided bilateral transversus abdominis plane block using 0.25% ropivacaine was perdormed by anesthesiologist who is not involved in intraoperative management and postoperative follow-up and evaluate the effect after the block completed.
DexmedetomidineDrug
After finished the transversus abdominis plane block, then perform tracheal intubation and start the infusion of dexmedetomidine.
Transversus abdominis plane block using salineProcedure or surgery
Before anesthesia, the ultrasound-guided bilateral transversus abdominis plane block using saline was perdormed by anesthesiologist who is not involved in intraoperative management and postoperative follow-up and evaluate the effect after the block completed.
SalineDrug
After finished the transversus abdominis plane block, then perform tracheal intubation and start the infusion of saline, dosage and infusion method of saline are consistent with dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| Dex+TAPB group | Experimental | Patients in Dex+TAPB group will receive the bilateral transversus abdominis plane block with 0.25% ropivacaine 20ml each side before anesthesia and combined with continuous infusion of dexmedetomidine during operation. Receives: Procedure: Transversus abdominis plane block using ropivacaine; Drug: Dexmedetomidine |
| Control group | Placebo comparator | Patients in control group will receive the bilateral transversus abdominis plane block with saline 20ml each side before anesthesia and don't receive the infusion of dexmedetomidine during operation. Receives: Procedure: Transversus abdominis plane block using saline; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prognosis of aged patients
The incidence of postoperative delirium, postoperative acute pain moderately to severely and poor postoperative recovery were composite endpoints to determine the prognosis of patients.
Measured: Postoperative 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516174
- Sponsor's protocol ID
- wys20200731
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transversus Abdominis Plane Block Combined With Dexmedetomidine Infusion on the Prognosis in Elderly Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04516174
- Acronym / sponsor ID
- wys20200731
- Conditions
- Colorectal Neoplasms, Aged
- Keywords
- Delirium, Pain, Postoperative, Dexmedetomidine, Transversus abdominis plane block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 18 Aug 2020 (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.
To compare the prognosis of elderly patients undergoing radical resection of colorectal cancer treated with general anesthesia and general anesthesia combined with transversus abdominis plane block and continuous infusion of dexmedetomidine. The incidence of postoperative delirium, postoperative acute pain moderately to severely and poor postoperative recovery were composite endpoints to determine the prognosis of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dex+TAPB group | Experimental | Procedure: Transversus abdominis plane block using ropivacaine, Drug: DexmedetomidinePatients in Dex+TAPB group will receive the bilateral transversus abdominis plane block with 0.25% ropivacaine 20ml each side before anesthesia and combined with continuous infusion of dexmedetomidine during operation. |
| Control group | Placebo comparator | Procedure: Transversus abdominis plane block using saline, Drug: SalinePatients in control group will receive the bilateral transversus abdominis plane block with saline 20ml each side before anesthesia and don't receive the infusion of dexmedetomidine during operation. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65-80 years,regardless of gender
- American Society of Anesthesiologists physical status I-III
- Undergoing elective radical resection of colorectal cancer
- Sign informed consent
Key exclusion criteria (2 listed)
- Could not cooperate to complete the pain VAS evaluation
- Could not cooperate to complete the cognitive function assessment
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 |
|---|---|---|
| Transversus abdominis plane block using ropivacaineBefore anesthesia, the ultrasound-guided bilateral transversus abdominis plane block using 0.25% ropivacaine was perdormed by anesthesiologist who is not involved in intraoperative management and postoperative follow-up and evaluate the effect after the block completed. | Procedure or surgery | Dex+TAPB group |
| DexmedetomidineAfter finished the transversus abdominis plane block, then perform tracheal intubation and start the infusion of dexmedetomidine. | Drug | Dex+TAPB group |
| Transversus abdominis plane block using salineBefore anesthesia, the ultrasound-guided bilateral transversus abdominis plane block using saline was perdormed by anesthesiologist who is not involved in intraoperative management and postoperative follow-up and evaluate the effect after the block completed. | Procedure or surgery | Control group |
| SalineAfter finished the transversus abdominis plane block, then perform tracheal intubation and start the infusion of saline, dosage and infusion method of saline are consistent with dexmedetomidine. | Drug | Control group |
Primary outcome
The prognosis of aged patients
Time frame: Postoperative 72 hours
The incidence of postoperative delirium, postoperative acute pain moderately to severely and poor postoperative recovery were composite endpoints to determine the prognosis of patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane block using ropivacaine, Dexmedetomidine and Transversus abdominis plane block using saline in people with Colorectal Neoplasms and Aged, run by Beijing Tiantan Hospital 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 4 inclusion and 2 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 18 Aug 2020. 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. Some participants in this study may receive a placebo. 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?
The prognosis of aged patients (time frame: Postoperative 72 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 18 Aug 2020.