Effect of Transversus Abdominis Plane Block Combined With Dexmedetomidine Infusion on the Prognosis in Elderly Patients Undergoing Abdominal Surgery

Colorectal Neoplasms Clinical Trial

Official title:

Effect of Transversus Abdominis Plane Block Combined With Dexmedetomidine Infusion on the Prognosis in Elderly Patients Undergoing Abdominal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04516174
• Other study ID #: wys20200731
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aged
• Colorectal Neoplasms

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