Colo-rectal CancerNCT04239794
The Influence of Type of Anesthesia on Postoperative Pain
A study testing Propofol and Sevoflurane in people with Colo-rectal Cancer and Anesthesia, run by Seoul National University Hospital at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Colo-rectal Cancer, Anesthesia
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 20 Feb 2020to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient scheduled for elective laparoscopic colorectal cancer surgery
Who cannot join
- Pregnant
- Conversion from laparoscopic to open surgery
- Allergy to anesthetics and analgesics
- Previous abdominal surgery
- Chronic pain
- Chronic analgesic usage
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
Seoul National University Bundang Hospital
Seoul, 13620
About this study
Official title: The Influence of Type of Anesthesia on Postoperative Pain After Laparoscopic Colorectal Cancer Surgery: Multi-center Prospective Randomized Controlled Study
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.
Read the detailed description
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
- Colo-rectal Cancer, Anesthesia
- Being tested
- Propofol, Sevoflurane
- Keywords
- Postoperative pain, Opioid consumption, Intraoperative anesthesia
- Medical subject headings
- Colonic Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Propofol 2%
General anesthesia during the laparoscopic colorectal surgery is achieved by using a target-controlled intravenous infusion of propofol.
SevofluraneDrug
Also called Sevoflurane inhalant product
General anesthesia during the laparoscopic colorectal surgery is achieved by using an inhalation agent (Sevoflurane).
| Study group | Role | What they receive |
|---|---|---|
| Inhalation anesthesia | Active comparator | Patients are anesthetized with sevoflurane and remifentanil infusion for maintenance of anesthesia during the surgery Receives: 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 Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 24 h opioid consumption
Cumulative opioid consumption for pain control 24 hours after the surgery
Measured: 24 hours after the surgery
Secondary outcomes (2)
Postoperative 48 h opioid consumption
Cumulative opioid consumption for pain control 48 hours after the surgery
Measured: 48 hours after the surgery
Numerical rating scale (NRS)
Numerical rating scale (NRS) pain score 24 and 48 hours after the surgery. NRS is an 11-point scale for patient self-reporting of pain; 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: 24 and 48 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 Feb 2020
- Primary completion19 Dec 2023
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239794
- Sponsor's protocol ID
- TIVA-IA-Pain
- Status last verified
- Dec 2023
- First submitted
- 21 Jan 2020
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30075537
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Type of Anesthesia on Postoperative Pain After Laparoscopic Colorectal Cancer Surgery: Multi-center Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04239794
- Acronym / sponsor ID
- TIVA-IA-Pain
- Conditions
- Colo-rectal Cancer, Anesthesia
- Keywords
- Postoperative pain, Opioid consumption, Intraoperative anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalation anesthesia | Active comparator | Drug: SevofluranePatients are anesthetized with sevoflurane and remifentanil infusion for maintenance of anesthesia during the surgery |
| Total intravenous anesthesia | Experimental | Drug: PropofolPatients are anesthetized with target-controlled intravenous infusion of propofol and remifentanil infusion for maintenance of anesthesia during the surgery |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient scheduled for elective laparoscopic colorectal cancer surgery
Key exclusion criteria (6 listed)
- Pregnant
- Conversion from laparoscopic to open surgery
- Allergy to anesthetics and analgesics
- Previous abdominal surgery
- Chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: Propofol 2%General anesthesia during the laparoscopic colorectal surgery is achieved by using a target-controlled intravenous infusion of propofol. | Drug | Total intravenous anesthesia |
| SevofluraneAlso: Sevoflurane inhalant productGeneral anesthesia during the laparoscopic colorectal surgery is achieved by using an inhalation agent (Sevoflurane). | Drug | Inhalation anesthesia |
Primary outcome
Postoperative 24 h opioid consumption
Time frame: 24 hours after the surgery
Cumulative opioid consumption for pain control 24 hours after the surgery
2 secondary outcomes
Postoperative 48 h opioid consumption
Time frame: 48 hours after the surgery
Numerical rating scale (NRS)
Time frame: 24 and 48 hours after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Background: PubMed 30075537Wong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tae Kim, PhD principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Colo-rectal Cancer and Anesthesia, run by Seoul National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative 24 h opioid consumption (time frame: 24 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04239794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.