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The Influence of Type of Anesthesia on Postoperative Pain

NCT ID: NCT04239794

Last Updated: 2023-12-22

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-20

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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Previous studies showed that patients receiving total intravenous anesthesia (TIVA) with propofol are associated with less postoperative pain and less opioid consumption compared with inhalation anesthesia. However, some studies showed conflicting results. In colorectal surgery, there are only retrospective studies that showed the analgesic effect of TIVA and inhalation anesthesia. The investigators designed a multi-center prospective randomized controlled trial and hypothesized that TIVA with propofol would be associated with reduced postoperative opioid consumption and less postoperative pain compared with sevoflurane in laparoscopic colorectal cancer surgery.

Conditions

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Colo-rectal Cancer Anesthesia

Keywords

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Postoperative pain Opioid consumption Intraoperative anesthesia

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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Inhalation anesthesia

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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

Total intravenous anesthesia

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

Sevoflurane

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

Intervention Type DRUG

Other Intervention Names

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Propofol 2% Sevoflurane inhalant product

Eligibility Criteria

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Inclusion Criteria

* Adult patient scheduled for elective laparoscopic colorectal cancer surgery

Exclusion Criteria

* Pregnant
* Conversion from laparoscopic to open surgery
* Allergy to anesthetics and analgesics
* Previous abdominal surgery
* Chronic pain
* Chronic analgesic usage
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Professor (full)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Seoul National University Bundang Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 30075537 (View on PubMed)

Other Identifiers

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TIVA-IA-Pain

Identifier Type: -

Identifier Source: org_study_id