Postoperative PainPhase 4TIVANCT05344911
Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA
A Phase 4 study testing Propofol combined with alfentanil and Propofol combined with remifentanil in people with Postoperative Pain, run by Xijing Hospital at 1 site in China.
Trial summary
Total intravenous anesthesia (TIVA) is maintained by intermittent or continuous combined intravenous injection of a variety of short-acting intravenous anesthetics, which can provide safe and rapid induction, maintenance and termination of general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Propofol combined with alfentanil and Propofol combined with remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2022to 30 Aug 2022
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years old
- ASA Ⅰ-Ⅲ
- patients undergoing functional endoscopic sinus surgery under general anesthesia.
Who cannot join
- Significant hypertension (diastolic blood pressure > 100mmHg) or hypotension (systolic . blood pressure < 100mmHg).
- severe mental, cardiovascular, kidney or liver disease.
- previous history of alcohol or drug abuse.
- long-term use of painkillers before operation.
- contraindications for any drugs used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA Undergoing Functional Endoscopic Sinus Surgery
Total intravenous anesthesia (TIVA) is maintained by intermittent or continuous combined intravenous injection of a variety of short-acting intravenous anesthetics, which can provide safe and rapid induction, maintenance and termination of general anesthesia. It has a slight effect on respiration and circulation, strong controllability, short anesthetic recovery time, reduced postoperative nausea and vomiting (PONV) and quick discharge time, so it has been widely used in clinic. Functional endoscopic sinus surgery is a common method for the treatment of sinusitis and other diseases. The trauma of this operation is less. The use of TIVA during the operation can reduce the bleeding in the surgical field and is beneficial to the recovery of patients.
The combination of propofol and remifentanil is the most common in TIVA because of its fast pharmacokinetics and short half-life. However, the disadvantage of remifentanil is the lack of residual analgesic effect after termination of continuous infusion. As postoperative nasal packing can still bring postoperative pain, patients with severe discomfort caused by pain will have unexpected conditions such as surgical incision cracking and bleeding, which will affect the effect of operation and rehabilitation. Afentanil is another opioid drug with short effect and strong analgesic effect. Previous studies have shown that remifentanil-based TIVA has slightly higher postoperative pain and early use of analgesics than TIVA in discectomy. Because the effect of TIVA using Afentanil or remifentanil on postoperative pain in functional nasal endoscopic surgery is not clear, this study intends to observe the effect of TIVA on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia, so as to optimize the clinical anesthetic scheme of this kind of minimally invasive surgery and provide clinical reference.
Read the detailed description
This study intends to observe the effect of TIVA using afentanil or remifentanil on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia.
Main indicators:
VAS score at 30 min after operation.
Secondary indicators:
VAS score of 60 min after operation. VAS score of 24h after operation. Number of cases of postoperative use of analgesics . Number of cases of postoperative adverse reactions.
- Conditions
- Postoperative Pain
- Being tested
- Propofol combined with alfentanil, Propofol combined with remifentanil
- Keywords
- functional endoscopic sinus surgery, postoperative pain, afentanil or remifentanil
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol combined with alfentanilDrug
Anesthesia induction: midazolam 0.02 mg/kg, propofol（TCI） 3 μ g/mL, alfentanil 20 μ g/kg and rocuronium 0.6 mg/kg . Anesthesia maintenance: target-controlled infusion of propofol combined with alfentanil(0.5-2ug/kg/min)
Propofol combined with remifentanilDrug
Anesthesia induction: midazolam 0.02 mg/kg, propofol（TCI） 3 μ g/mL, remifentanil 1μ g/kg and rocuronium 0.6 mg/kg . Anesthesia maintenance: target-controlled infusion of propofol combined with remifentanil(0.1-0.3ug/kg/min)
| Study group | Role | What they receive |
|---|---|---|
| remifentanil | Active comparator | Anesthesia maintenance：target-controlled infusion of propofol combined with remifentanil） Receives: Drug: Propofol combined with remifentanil |
| alfentanil | Experimental | Anesthesia maintenance：target-controlled infusion of propofol combined with afentanil Receives: Drug: Propofol combined with alfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
the digital rating scale (VAS) uses a number between 0 and 10 to indicate that there is no pain; a score of 1-3 means that a slight pain can be tolerated; a score of 4-6 indicates that it is bearable if it does not affect sleep; a score of 7-10 indicates that it is becoming more and more painful and unbearable, affecting appetite and sleep
Measured: Postoperative 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start29 Apr 2022
- Primary completion20 Jul 2022
- Study completion30 Aug 2022
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Xijing 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Jia, Principal investigator, The First Affiliated Hospital of the Air Force Medical Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344911
- Sponsor's protocol ID
- xijing2022-0410
- Acronym
- TIVA
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doganay G, Ekmekci P, Kazbek BK, Yilmaz H, Erkan G, Tuzuner F. Effects of alfentanil or fentanyl added to propofol for sedation in colonoscopy on cognitive functions: Randomized controlled trial. Turk J Gastroenterol. 2017 Nov;28(6):453-459. doi: 10.5152/tjg.2017.16489. Epub 2017 Sep 19.
PubMed 28928100
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA Undergoing Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT05344911
- Acronym / sponsor ID
- TIVA / xijing2022-0410
- Conditions
- Postoperative Pain
- Keywords
- functional endoscopic sinus surgery, postoperative pain, afentanil or remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 25 Apr 2022 (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.
Total intravenous anesthesia (TIVA) is maintained by intermittent or continuous combined intravenous injection of a variety of short-acting intravenous anesthetics, which can provide safe and rapid induction, maintenance and termination of general anesthesia. It has a slight effect on respiration and circulation, strong controllability, short anesthetic recovery time, reduced postoperative nausea and vomiting (PONV) and quick discharge time, so it has been widely used in clinic. Functional endoscopic sinus surgery is a common method for the treatment of sinusitis and other diseases. The trauma of this operation is less. The use of TIVA during the operation can reduce the bleeding in the surgical field and is beneficial to the recovery of patients.
The combination of propofol and remifentanil is the most common in TIVA because of its fast pharmacokinetics and short half-life. However, the disadvantage of remifentanil is the lack of residual analgesic effect after termination of continuous infusion. As postoperative nasal packing can still bring postoperative pain, patients with severe discomfort caused by pain will have unexpected conditions such as surgical incision cracking and bleeding, which will affect the effect of operation and rehabilitation. Afentanil is another opioid drug with short effect and strong analgesic effect. Previous studies have shown that remifentanil-based TIVA has slightly higher postoperative pain and early use of analgesics than TIVA in discectomy. Because the effect of TIVA using Afentanil or remifentanil on postoperative pain in functional nasal endoscopic surgery is not clear, this study intends to observe the effect of TIVA on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia, so as to optimize the clinical anesthetic scheme of this kind of minimally invasive surgery and provide clinical reference.
Detailed description
This study intends to observe the effect of TIVA using afentanil or remifentanil on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia.
Main indicators:
VAS score at 30 min after operation.
Secondary indicators:
VAS score of 60 min after operation. VAS score of 24h after operation. Number of cases of postoperative use of analgesics . Number of cases of postoperative adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remifentanil | Active comparator | Drug: Propofol combined with remifentanilAnesthesia maintenance：target-controlled infusion of propofol combined with remifentanil） |
| alfentanil | Experimental | Drug: Propofol combined with alfentanilAnesthesia maintenance：target-controlled infusion of propofol combined with afentanil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years old
- ASA Ⅰ-Ⅲ
- patients undergoing functional endoscopic sinus surgery under general anesthesia.
Key exclusion criteria (5 listed)
- Significant hypertension (diastolic blood pressure > 100mmHg) or hypotension (systolic . blood pressure < 100mmHg).
- severe mental, cardiovascular, kidney or liver disease.
- previous history of alcohol or drug abuse.
- long-term use of painkillers before operation.
- contraindications for any drugs used in the study.
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 |
|---|---|---|
| Propofol combined with alfentanilAnesthesia induction: midazolam 0.02 mg/kg, propofol（TCI） 3 μ g/mL, alfentanil 20 μ g/kg and rocuronium 0.6 mg/kg . Anesthesia maintenance: target-controlled infusion of propofol combined with alfentanil(0.5-2ug/kg/min) | Drug | alfentanil |
| Propofol combined with remifentanilAnesthesia induction: midazolam 0.02 mg/kg, propofol（TCI） 3 μ g/mL, remifentanil 1μ g/kg and rocuronium 0.6 mg/kg . Anesthesia maintenance: target-controlled infusion of propofol combined with remifentanil(0.1-0.3ug/kg/min) | Drug | remifentanil |
Primary outcome
VAS score
Time frame: Postoperative 30minutes
the digital rating scale (VAS) uses a number between 0 and 10 to indicate that there is no pain; a score of 1-3 means that a slight pain can be tolerated; a score of 4-6 indicates that it is bearable if it does not affect sleep; a score of 7-10 indicates that it is becoming more and more painful and unbearable, affecting appetite and sleep
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 19 Jan 2023.
- Background: PubMed 28928100Doganay G, Ekmekci P, Kazbek BK, Yilmaz H, Erkan G, Tuzuner F. Effects of alfentanil or fentanyl added to propofol for sedation in colonoscopy on cognitive functions: Randomized controlled trial. Turk J Gastroenterol. 2017 Nov;28(6):453-459. doi: 10.5152/tjg.2017.16489. Epub 2017 Sep 19.
- Doğanay G, Ekmekçi P, Kazbek BK, et al. Effects of alfentanil or fentanyl added to propofol for sedation in colonoscopy on cognitive functions: Randomized controlled trial. Turk J Gastroenterol. 2017 ,28(6):453-459.Link provided by the sponsor.
- 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.
Yan Jia principal investigator
The First Affiliated Hospital of the Air Force Medical Universtiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol combined with alfentanil and Propofol combined with remifentanil in people with Postoperative Pain, run by Xijing Hospital at 1 site in China.
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 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 19 Jan 2023. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
VAS score (time frame: Postoperative 30minutes). 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 NCT05344911, 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 19 Jan 2023.