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

August 17, 2020 updated by: Yuming Peng, Beijing Tiantan Hospital
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100070
        • Beijing Tian Tan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dex+TAPB group
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.
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.
PLACEBO_COMPARATOR: Control group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

September 1, 2023

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (ACTUAL)

August 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wys20200731

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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