NCT04239794

Brief Summary

The investigators designed a multi-center prospective randomized controlled trial to study the influence of the type of anesthesia on postoperative pain after laparoscopic colorectal cancer surgery. Half of the participants will be anesthetized with propofol and remifentanil, while the other half will be anesthetized with sevoflurane and remifentanil during the surgery. The investigators will measure opioid consumption and pain score in the acute postoperative phase.

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
468

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

3.8 years

First QC Date

January 21, 2020

Last Update Submit

December 21, 2023

Conditions

Colo-rectal CancerAnesthesia

Keywords

Postoperative painOpioid consumptionIntraoperative anesthesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative 24 h opioid consumption

    Cumulative opioid consumption for pain control 24 hours after the surgery

    24 hours after the surgery

Secondary Outcomes (2)

  • Postoperative 48 h opioid consumption

    48 hours after the surgery

  • Numerical rating scale (NRS)

    24 and 48 hours after the surgery

Study Arms (2)

Inhalation anesthesia

ACTIVE COMPARATOR

Patients are anesthetized with sevoflurane and remifentanil infusion for maintenance of anesthesia during the surgery

Drug: Sevoflurane

Total intravenous anesthesia

EXPERIMENTAL

Patients are anesthetized with target-controlled intravenous infusion of propofol and remifentanil infusion for maintenance of anesthesia during the surgery

Drug: Propofol

Interventions

PropofolDRUG

General anesthesia during the laparoscopic colorectal surgery is achieved by using a target-controlled intravenous infusion of propofol.

Also known as: Propofol 2%
Total intravenous anesthesia
SevofluraneDRUG

General anesthesia during the laparoscopic colorectal surgery is achieved by using an inhalation agent (Sevoflurane).

Also known as: Sevoflurane inhalant product
Inhalation anesthesia

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient scheduled for elective laparoscopic colorectal cancer surgery

You may not qualify if:

  • Pregnant
  • Conversion from laparoscopic to open surgery
  • Allergy to anesthetics and analgesics
  • Previous abdominal surgery
  • Chronic pain
  • Chronic analgesic usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Seoul National University Bundang Hospital

Seoul, 13620, South Korea

Location

Related Publications (1)

  • Wong SSC, Choi SW, Lee Y, Irwin MG, Cheung CW. The analgesic effects of intraoperative total intravenous anesthesia (TIVA) with propofol versus sevoflurane after colorectal surgery. Medicine (Baltimore). 2018 Aug;97(31):e11615. doi: 10.1097/MD.0000000000011615.

    PMID: 30075537BACKGROUND

MeSH Terms

Conditions

Colonic NeoplasmsPain, Postoperative

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Jin-Tae Kim, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

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
Professor (full)

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

February 20, 2020

Primary Completion

December 19, 2023

Study Completion

January 31, 2024

Last Updated

December 22, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(3)