Patients Undergoing Laparoscopic NephrectomyNCT03171610
Study on Efficacy of iv PCA With Fentanyl or Sufentanil in Patients Undergoing Laparoscopic Nephrectomy
A study testing Sufentanil group and Fentanyl group in people with Patients Undergoing Laparoscopic Nephrectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Patients Undergoing Laparoscopic Nephrectomy
- What is being tested?
- Sufentanil group and Fentanyl group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2017to 3 Jan 2018
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing laparoscopic or robot-assisted laparoscopic nephrectomy (total or partial)
- patient who want intravenous PCA for postoperative pain control
Who cannot join
- long-term use of opioid, pain reliever or tranquilizers
- a history of DM neuritis
- prolonged prothrombin time or activated partial thromboplastin time
- impairment of cognitive function
- obesity (BMI ≥ BMI 30 kg/m2)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
Seoul, 03722
About this study
Official title: Randomized Double-blind Study on Efficacy of iv PCA With Fentanyl or Sufentanil in Patients Undergoing Laparoscopic Nephrectomy
The purpose of this study is to compare the efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy
- Being tested
- Sufentanil group, Fentanyl group
- Keywords
- laparoscopic nephrectomy, Patient-controlled analgesia (PCA), sufentanil, fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil groupDrug
PCA device containing sufentanil (3 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml was connected.
Fentanyl groupDrug
PCA device containing fentanyl (20 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml was connected.
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil group | Experimental | Arm Description: PCA with sufentanil (3 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml Receives: Drug: Sufentanil group |
| Fentanyl group | Active comparator | PCA with fentanyl (20 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml Receives: Drug: Fentanyl group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy: Incidence of postoperative nausea and vomiting (PONV)
Incidence of postoperative nausea and vomiting (PONV)
Measured: 24 hrs after recovery room discharge
Secondary outcomes (1)
postoperative pain score
NRPS (numerical verbal rating score of pain)
Measured: at arrival to recovery room, 30 minutes after arrival to recovery room, 1 hour after recovery room discharge, 6 hrs after recovery room discharge, 24 hrs after recovery room discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start13 Jun 2017
- Primary completion3 Jan 2018
- Study completion3 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Laparoscopic NephrectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171610
- Sponsor's protocol ID
- 4-2017-0201
- Status last verified
- Mar 2018
- First submitted
- 22 May 2017
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Study on Efficacy of iv PCA With Fentanyl or Sufentanil in Patients Undergoing Laparoscopic Nephrectomy
- ClinicalTrials.gov ID
- NCT03171610
- Acronym / sponsor ID
- 4-2017-0201
- Keywords
- laparoscopic nephrectomy, Patient-controlled analgesia (PCA), sufentanil, fentanyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 3 Jan 2018 (actual)
- First posted
- 31 May 2017 (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 purpose of this study is to compare the efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil group | Experimental | Drug: Sufentanil groupArm Description: PCA with sufentanil (3 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml |
| Fentanyl group | Active comparator | Drug: Fentanyl groupPCA with fentanyl (20 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing laparoscopic or robot-assisted laparoscopic nephrectomy (total or partial)
- patient who want intravenous PCA for postoperative pain control
Key exclusion criteria (5 listed)
- long-term use of opioid, pain reliever or tranquilizers
- a history of DM neuritis
- prolonged prothrombin time or activated partial thromboplastin time
- impairment of cognitive function
- obesity (BMI ≥ BMI 30 kg/m2)
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 |
|---|---|---|
| Sufentanil groupPCA device containing sufentanil (3 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml was connected. | Drug | Sufentanil group |
| Fentanyl groupPCA device containing fentanyl (20 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml was connected. | Drug | Fentanyl group |
Primary outcome
Efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy: Incidence of postoperative nausea and vomiting (PONV)
Time frame: 24 hrs after recovery room discharge
Incidence of postoperative nausea and vomiting (PONV)
1 secondary outcome
postoperative pain score
Time frame: at arrival to recovery room, 30 minutes after arrival to recovery room, 1 hour after recovery room discharge, 6 hrs after recovery room discharge, 24 hrs after recovery room 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 15 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Patients Undergoing Laparoscopic Nephrectomy
Not yet recruitingObservational study
The Impact of Lumboscopy Versus Laparoscopy on Ventilatory Mechanics
Anesthesia, Mechanical Ventilation
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 Sufentanil group and Fentanyl group in people with Patients Undergoing Laparoscopic Nephrectomy, run by Yonsei University 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 2 inclusion and 5 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 15 Mar 2018. 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?
Efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy: Incidence of postoperative nausea and vomiting (PONV) (time frame: 24 hrs after recovery room discharge). 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 15 Mar 2018.