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

Primary Purpose

Colorectal Neoplasms, Aged

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transversus abdominis plane block using ropivacaine
Dexmedetomidine
Transversus abdominis plane block using saline
Saline
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasms focused on measuring Delirium, Pain, Postoperative, Dexmedetomidine, Transversus abdominis plane block

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Tian Tan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dex+TAPB group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2020
Last Updated
August 17, 2020
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04516174
Brief Title
Effect of Transversus Abdominis Plane Block Combined With Dexmedetomidine Infusion on the Prognosis in Elderly Patients Undergoing Abdominal Surgery
Official Title
Effect of Transversus Abdominis Plane Block Combined With Dexmedetomidine Infusion on the Prognosis in Elderly Patients Undergoing Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Aged
Keywords
Delirium, Pain, Postoperative, Dexmedetomidine, Transversus abdominis plane block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dex+TAPB group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block using ropivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
After finished the transversus abdominis plane block, then perform tracheal intubation and start the infusion of dexmedetomidine.
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block using saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
The prognosis of aged patients
Description
The incidence of postoperative delirium, postoperative acute pain moderately to severely and poor postoperative recovery were composite endpoints to determine the prognosis of patients.
Time Frame
Postoperative 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Beijing Tian Tan Hospital
City
Beijing
ZIP/Postal Code
100070
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D
Phone
8610-59976660
Email
ruquan.han@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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