NCT04516174

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2.3 years

First QC Date

August 11, 2020

Last Update Submit

August 17, 2020

Conditions

Colorectal NeoplasmsAged

Keywords

DeliriumPain, PostoperativeDexmedetomidineTransversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Dex+TAPB group

EXPERIMENTAL

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 ropivacaineDrug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

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 salineDrug: Saline

Interventions

Transversus abdominis plane block using ropivacainePROCEDURE

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.

Dex+TAPB group
DexmedetomidineDRUG

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

Dex+TAPB group
Transversus abdominis plane block using salinePROCEDURE

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.

Control group
SalineDRUG

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.

Control group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Could not cooperate to complete the pain VAS evaluation
  • Could not cooperate to complete the cognitive function assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tian Tan Hospital

Beijing, 100070, China

Location

MeSH Terms

Conditions

Colorectal NeoplasmsDeliriumPain, Postoperative

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPostoperative ComplicationsPathologic ProcessesPain

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Professor

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 18, 2020

Study Start

September 1, 2020

Primary Completion

December 31, 2022

Study Completion

September 1, 2023

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations

CN(1)