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

NCT ID: NCT04516174

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Neoplasms Aged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Transversus abdominis plane block using ropivacaine

Intervention Type PROCEDURE

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.

Dexmedetomidine

Intervention Type DRUG

After finished the transversus abdominis plane block, then perform tracheal intubation and start the infusion of dexmedetomidine.

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.

Group Type PLACEBO_COMPARATOR

Transversus abdominis plane block using saline

Intervention Type PROCEDURE

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.

Saline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type PROCEDURE

Dexmedetomidine

After finished the transversus abdominis plane block, then perform tracheal intubation and start the infusion of dexmedetomidine.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuming Peng

Vice Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tian Tan Hospital

Beijing, , China

Site Status

Countries

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China

Facility Contacts

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Ruquan Han, M.D., Ph.D

Role: primary

8610-59976660

Other Identifiers

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wys20200731

Identifier Type: -

Identifier Source: org_study_id

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