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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04516174
Other study ID # wys20200731
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 1, 2023

Study information

Verified date August 2020
Source Beijing Tiantan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The incidence of postoperative delirium, postoperative acute pain moderately to severely and poor postoperative recovery were composite endpoints to determine the prognosis of patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date September 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Could not cooperate to complete the pain VAS evaluation

- Could not cooperate to complete the cognitive function assessment

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transversus abdominis plane block using ropivacaine
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.
Drug:
Dexmedetomidine
After finished the transversus abdominis plane block, then perform tracheal intubation and start the infusion of dexmedetomidine.
Procedure:
Transversus abdominis plane block using saline
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.
Drug:
Saline
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.

Locations

Country Name City State
China Beijing Tian Tan Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Postoperative 72 hours
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