AnesthesiaNCT03868111
Sufentanil as Adjuvant of Balanced Anesthesia
A study testing Sufentanil and Remifentanil in people with Anesthesia, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The aim of the study was to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced general anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sufentanil and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Nov 2019to 12 Jan 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 19 and 65 years
- Patients with American Society of Anesthesiologists physical status I or II
- Patients scheduled for elective laparoscopic cholecystectomy under balanced general anesthesia for benign cholecystic diseases
- Patients obtaining written informed consent
Who cannot join
- Patients with asthma or hypertension
- Patients with an inability to express their pain accurately
- Patients with an inability to understand the pain scale
- Patients with chronic abdominal pain or chronic pain syndrome
- Patients who required to convert to laparotomy from laparoscopic surgery
- Patients who required to receive incidental lower abdominal procedures owing to adhesion, injury, or other incidental findings at the lower abdominal cavity
- Patients with a history of drug or alcohol abuse
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Sufentanil and Remifentanil as General Anesthetic Adjuvant
The aim of the study was to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced general anesthesia.
Read the detailed description
The investigators hypothesized that sufentanil would reduce postoperative pain than remifentanil without prolonging recovery times in minor laparoscopic surgery when administered equivalent antinociceptive doses during surgery. Intraoperative opioid administration for equivalent nociception-antinociception balance could be achieved via surgical pleth index (SPI)-guided analgesia. This study was designed to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced anesthesia in patients undergoing laparoscopic cholecystectomy under SPI-guided opioid administration.
- Conditions
- Anesthesia
- Being tested
- Sufentanil, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Also called Group S
The infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
RemifentanilDrug
Also called Group R
The infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil | Experimental | Balanced anesthesia is maintained with 1 MAC desflurane and sufentanil during laparoscopic cholecystectomy. Receives: Drug: Sufentanil |
| Remifentanil | Experimental | Balanced anesthesia is maintained with 1 MAC desflurane and remifentanil during laparoscopic cholecystectomy. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative wound pain score
The pain score is evaluated by 10 point visual analogue scale at post-anesthesia care unit. The visual analogue scale is presented as a 10-cm line with verbal descriptors indicating "no pain" and "pain as bad as it could be". The visual analogue scale ranges from 0 to 10, representing minimum and maximum pain levels, respectively.
Measured: 10 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start4 Nov 2019
- Primary completion12 Jan 2020
- Study completion12 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyoung-Ho Ryu, MD, Kangbuk Samsung Hospital
- Investigators
- Kyoung-Ho Ryu, M.D., Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868111
- Sponsor's protocol ID
- 2019-02-001
- Status last verified
- Jun 2020
- First submitted
- 6 Mar 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Sufentanil and Remifentanil as General Anesthetic Adjuvant
- ClinicalTrials.gov ID
- NCT03868111
- Acronym / sponsor ID
- 2019-02-001
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 12 Jan 2020 (actual)
- First posted
- 8 Mar 2019 (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 aim of the study was to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced general anesthesia.
Detailed description
The investigators hypothesized that sufentanil would reduce postoperative pain than remifentanil without prolonging recovery times in minor laparoscopic surgery when administered equivalent antinociceptive doses during surgery. Intraoperative opioid administration for equivalent nociception-antinociception balance could be achieved via surgical pleth index (SPI)-guided analgesia. This study was designed to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced anesthesia in patients undergoing laparoscopic cholecystectomy under SPI-guided opioid administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil | Experimental | Drug: SufentanilBalanced anesthesia is maintained with 1 MAC desflurane and sufentanil during laparoscopic cholecystectomy. |
| Remifentanil | Experimental | Drug: RemifentanilBalanced anesthesia is maintained with 1 MAC desflurane and remifentanil during laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 19 and 65 years
- Patients with American Society of Anesthesiologists physical status I or II
- Patients scheduled for elective laparoscopic cholecystectomy under balanced general anesthesia for benign cholecystic diseases
- Patients obtaining written informed consent
Key exclusion criteria (8 listed)
- Patients with asthma or hypertension
- Patients with an inability to express their pain accurately
- Patients with an inability to understand the pain scale
- Patients with chronic abdominal pain or chronic pain syndrome
- Patients who required to convert to laparotomy from laparoscopic surgery
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 |
|---|---|---|
| SufentanilAlso: Group SThe infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time. | Drug | Sufentanil |
| RemifentanilAlso: Group RThe infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time. | Drug | Remifentanil |
Primary outcome
Postoperative wound pain score
Time frame: 10 minutes after surgery
The pain score is evaluated by 10 point visual analogue scale at post-anesthesia care unit. The visual analogue scale is presented as a 10-cm line with verbal descriptors indicating "no pain" and "pain as bad as it could be". The visual analogue scale ranges from 0 to 10, representing minimum and maximum pain levels, respectively.
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 4 Jun 2020.
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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.
Kyoung-Ho Ryu, M.D. principal investigator
Kangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sufentanil and Remifentanil in people with Anesthesia, run by Kangbuk Samsung 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 4 inclusion and 8 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 4 Jun 2020. 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?
Postoperative wound pain score (time frame: 10 minutes after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2020.