Enhanced Recovery After SurgeryNCT04447105
Comparison of Postoperative Recovery Between TIVA and Inhalation Agent
A study testing total intravenous anesthesia with propofol and inhalation anesthesia with desflurane in people with Enhanced Recovery After Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This prospective, randomized, single-blinded study is designed to compare the postoperative quality of recovery between propofol based total intravenous anesthesia and desflurane in patients undergoing minimally invasive nephrectomy. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Enhanced Recovery After Surgery
- What is being tested?
- total intravenous anesthesia with propofol and inhalation anesthesia with desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jun 2020to 27 Jul 2021
- 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
- Patients scheduled to undergo elective laparoscopic or robotic assisted nephrectomy under general anesthesia
- American Society of Anesthesiologists (ASA) physical classification I-II
- Willingness and ability to sign an informed consent document
Who cannot join
- Do not understand our study
- American Society of Anesthesiologists (ASA) physical classification III or more
- Allergies to anesthetic or analgesic medications
- Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
- Medical or psychological disease that can affect the treatment response
- Patients who receive mechanical ventilation more than 2 hours after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of the Effect of General Anesthetics on Postoperative Recovery After Minimally Invasive Nephrectomy (REGAIN Trial)
This prospective, randomized, single-blinded study is designed to compare the postoperative quality of recovery between propofol based total intravenous anesthesia and desflurane in patients undergoing minimally invasive nephrectomy. We hypothesize that propofol based total intravenous anesthesia can significantly improve the quality of recovery after surgery in patients with minimally invasive nephrectomy.
Read the detailed description
Adult patients undergoing elective laparoscopic or robotic assisted nephrectomy are randomly allocated to receive propofol based total intravenous anesthesia (n=75) or desflurane (n=75). The quality of recover after surgery using the QoR-15K was assessed by a investigator at postoperative day (POD) 1, 2, and 3. The primary outcome is the QoR-15K at POD 1, 2, and 3 after surgery.
- Conditions
- Enhanced Recovery After Surgery
- Being tested
- total intravenous anesthesia with propofol, inhalation anesthesia with desflurane
- Keywords
- quality of recovery after surgery, anesthetic method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total intravenous anesthesia with propofolDrug
Also called TIVA group
In the TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using infusion pump (Orchestra®; Fresenius Vial, Brezins, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
inhalation anesthesia with desfluraneDrug
Also called DES group
In the desflurane group, anesthesia is induced with propofol 1-2 mg/kg and maintained with desflurane (5-7 vol %). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
| Study group | Role | What they receive |
|---|---|---|
| TIVA group | Experimental | Patients receiving total intravenous anesthesia with propofol. Receives: Drug: total intravenous anesthesia with propofol |
| Desflurane group | Active comparator | Patients receiving inhalation anesthesia with desflurane. Receives: Drug: inhalation anesthesia with desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery
Change in the QoR-15K score from 24 hours to 72 hours postoperatively
Measured: at 24 hours, 48 hours, 72 hours postoperatively
Secondary outcomes (8)
Postoperative pain score
Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting/movement from 24 hours to 72 hours postoperatively
Measured: at 24 hours, 48 hours, 72 hours postoperatively
Postoperative nausea and vomiting during the first 24 hours postoperatively
Incidence of postoperative nausea and vomiting (%)
Measured: during the first 24 hours postoperatively
Postoperative nausea and vomiting during the 24-48 hours postoperatively
Incidence of postoperative nausea and vomiting (%)
Measured: during the 24-48 hours postoperatively
Postoperative nausea and vomiting during the 48-72 hours postoperatively
Incidence of postoperative nausea and vomiting (%)
Measured: during the 48-72 hours postoperatively
Total fentanyl consumption during the first 24 hours postoperatively
Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively
Measured: during the first 24 hours postoperatively
Total fentanyl consumption during the 24-48 hours postoperatively
Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively
Measured: during the 24-48 hours postoperatively
Total fentanyl consumption during the 48-72 hours postoperatively
Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively
Measured: during the 48-72 hours postoperatively
Quality of life at early post-discharge
Change in the Quality of life measured using the EuroQoL 5-dimension 5-level scale (EQ-5D-5L) from baseline to early-postdischarge phase
Measured: day before surgery and at 3 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start28 Jun 2020
- Primary completion5 Jul 2021
- Study completion27 Jul 2021
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 Enhanced Recovery After SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized single-blinded study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hojin Lee, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447105
- Sponsor's protocol ID
- 2003-177-1113
- Status last verified
- Aug 2021
- First submitted
- 23 Jun 2020
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.
PubMed 25500679
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Effect of General Anesthetics on Postoperative Recovery After Minimally Invasive Nephrectomy (REGAIN Trial)
- ClinicalTrials.gov ID
- NCT04447105
- Acronym / sponsor ID
- 2003-177-1113
- Conditions
- Enhanced Recovery After Surgery
- Keywords
- quality of recovery after surgery, anesthetic method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2020 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 25 Jun 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.
This prospective, randomized, single-blinded study is designed to compare the postoperative quality of recovery between propofol based total intravenous anesthesia and desflurane in patients undergoing minimally invasive nephrectomy. We hypothesize that propofol based total intravenous anesthesia can significantly improve the quality of recovery after surgery in patients with minimally invasive nephrectomy.
Detailed description
Adult patients undergoing elective laparoscopic or robotic assisted nephrectomy are randomly allocated to receive propofol based total intravenous anesthesia (n=75) or desflurane (n=75). The quality of recover after surgery using the QoR-15K was assessed by a investigator at postoperative day (POD) 1, 2, and 3. The primary outcome is the QoR-15K at POD 1, 2, and 3 after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective randomized single-blinded study
| Arm | Type | Receives |
|---|---|---|
| TIVA group | Experimental | Drug: total intravenous anesthesia with propofolPatients receiving total intravenous anesthesia with propofol. |
| Desflurane group | Active comparator | Drug: inhalation anesthesia with desfluranePatients receiving inhalation anesthesia with desflurane. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled to undergo elective laparoscopic or robotic assisted nephrectomy under general anesthesia
- American Society of Anesthesiologists (ASA) physical classification I-II
- Willingness and ability to sign an informed consent document
Key exclusion criteria (6 listed)
- Do not understand our study
- American Society of Anesthesiologists (ASA) physical classification III or more
- Allergies to anesthetic or analgesic medications
- Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
- Medical or psychological disease that can affect the treatment response
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 |
|---|---|---|
| total intravenous anesthesia with propofolAlso: TIVA groupIn the TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using infusion pump (Orchestra®; Fresenius Vial, Brezins, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure. | Drug | TIVA group |
| inhalation anesthesia with desfluraneAlso: DES groupIn the desflurane group, anesthesia is induced with propofol 1-2 mg/kg and maintained with desflurane (5-7 vol %). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure. | Drug | Desflurane group |
Primary outcome
quality of recovery
Time frame: at 24 hours, 48 hours, 72 hours postoperatively
Change in the QoR-15K score from 24 hours to 72 hours postoperatively
8 secondary outcomes
Postoperative pain score
Time frame: at 24 hours, 48 hours, 72 hours postoperatively
Postoperative nausea and vomiting during the first 24 hours postoperatively
Time frame: during the first 24 hours postoperatively
Postoperative nausea and vomiting during the 24-48 hours postoperatively
Time frame: during the 24-48 hours postoperatively
Postoperative nausea and vomiting during the 48-72 hours postoperatively
Time frame: during the 48-72 hours postoperatively
Total fentanyl consumption during the first 24 hours postoperatively
Time frame: during the first 24 hours postoperatively
Total fentanyl consumption during the 24-48 hours postoperatively
Time frame: during the 24-48 hours postoperatively
Total fentanyl consumption during the 48-72 hours postoperatively
Time frame: during the 48-72 hours postoperatively
Quality of life at early post-discharge
Time frame: day before surgery and at 3 weeks after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 25500679Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total intravenous anesthesia with propofol and inhalation anesthesia with desflurane in people with Enhanced Recovery After Surgery, run by Seoul National University Hospital at 1 site 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 3 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: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
quality of recovery (time frame: at 24 hours, 48 hours, 72 hours postoperatively). 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 NCT04447105, 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 5 Aug 2021.