AnesthesiaNCT04976842
Opioid-free Anesthesia and Acute Postoperative Pain
A study testing OFA and OBA in people with Anesthesia and Postoperative Pain, run by Attikon Hospital at 1 site in Greece.
Trial summary
Control of intraoperative and postoperative pain with the use of opioids constitutes normal practice. Opioid free anesthesia (OFA) is a relatively recent anesthesiology practice according to which opioids are not administered during surgery and are avoided postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Postoperative Pain, Cognitive Impairment, Variable
- What is being tested?
- OFA and OBA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 1 Aug 2019to 1 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged>18 years old
- ASA I-III
- Patients scheduled for elective transurethral urologic surgery with general anesthesia
Who cannot join
- • Patient refusal
- Use of opioids pre-op
- Inability to read or write
- Known psychiatric disease under medication
- Dementia
- Severe liver and renal disease
Show all 11Show fewer
- Known allergy to drugs used
- Known arrhythmia (2nd-3rd AV block, acute unstable angina, acute myocardial infarction in the past 6 weeks or severe cardiac problem-condition)
- Heart rate<45 bpm
- Pre-op minimental test<23
- Major surgery complications (hemorrhage with need for transfusion)
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, 12462
Chrysanthi Batistaki, MD, PhD, 0030 210 5832371, chrysabatistaki@yahoo.gr
About this study
Official title: Acute Postoperative Pain in Opioid-free Anesthesia After Urological Procedures
Control of intraoperative and postoperative pain with the use of opioids constitutes normal practice. Opioid free anesthesia (OFA) is a relatively recent anesthesiology practice according to which opioids are not administered during surgery and are avoided postoperatively. Opioid free anesthesia seems to provide better quality of postoperative analgesia while protecting the patient from the side effects of opioids such as respiratory depression, postoperative nausea and vomiting (PONV), opioid induced hyperalgesia and postoperative cognitive dysfunction. The aim of this study is to investigate the possible difference in the intensity of postoperative pain (based on the numeric rating scale 0-10) and the presence of PONV in patients undergoing transurethral urologic surgery under general anesthesia, when patients receive randomly either opioid free anesthesia (OFA) or opioid based anesthesia (OBA).
Read the detailed description
This study aimed to study postoperative pain after opioid free anesthesia or opioid based anesthesia after urologica; procedures. The two study groups opioid free (OFA) and opioid based (OBA) were as follows:
OFA: Anesthesiology technique based on Mulier protocol. Before induction, loading dose of dexmedetomidine 0,25mcg/kg (max 20mcg). Induction with dexmedetomidine 0,1mcg/kg, lidocaine 1mg/kg, ketamine 0,1mg/kg plus propofol 2mg/kg plus rocuronium1mg/kg IBW (if required). Maintenance with dexmedetomidine 0,1mcg/kg/h, lidocaine 1mg/kg/h, ketamine 0,1mg/kg/h and propofol infusion adjusted according to bispectral index indication ( BIS maintained 40-60). 15 minutes prior to end of surgery, the dose of drugs is reduced to dexmedetomidine 0,05mcg/kg/h, lidocaine 0,5mg/kg/h, ketamine 0,05mg/kg/h.
OBA: Total intravenous anesthesia with propofol for maintenance of anesthesia. Fentanyl 2mcg/kg only at induction and infusion of propofol and remifentanil for maintenance, with doses adjusted according to bispectral index indication ( BIS maintained 40-60).
Both groups receive ranitidine 50mg, dexamethasone 4 mg and paracetamol 1g iv 15 min before the end of surgery. Postoperative analgesia for both groups consists of paracetamol 3g/24h iv, rescue analgesia with tramadol 1mg/kg iv max x3, rescue for PONV ondacetron 4 mg iv.
The outcomes assessed were:
Primary outcome:
- Intensity of acute postoperative pain (NRS 0-10), time frame up to 24h postoperatively
- Nausea and vomiting
Secondary outcome:
- Change in minimental state evaluation test, time frame pre-op, 1h post-op, at discharge
- Severe postoperative adverse effect related to anesthesia (postoperative hypoxemia, ileus, postoperative cognitive dysfunction)
- Being tested
- OFA, OBA
- Keywords
- ANESTHESIA, OPIOIDS, PAIN, COGNITIVE
- Medical subject headings
- Pain, Postoperative, Cognitive Dysfunction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFADevice
Anesthesiology technique based on Mulier protocol. Before induction, loading dose of dexmedetomidine 0,25mcg/kg (max 20mcg). Induction with dexmedetomidine 0,1mcg/kg, lidocaine 1mg/kg, ketamine 0,1mg/kg plus propofol 2mg/kg plus rocuronium1mg/kg IBW (if required). Maintenance with dexmedetomidine 0,1mcg/kg/h, lidocaine 1mg/kg/h, ketamine 0,1mg/kg/h and propofol infusion adjusted according to bispectral index indication ( BIS maintained 40-60). 15 minutes prior to end of surgery, the dose of drugs is reduced to dexmedetomidine 0,05mcg/kg/h, lidocaine 0,5mg/kg/h, ketamine 0,05mg/kg/h.
OBADrug
Total intravenous anesthesia with propofol for maintenance of anesthesia. Fentanyl 2mcg/kg only at induction and infusion of propofol and remifentanil for maintenance, with doses adjusted according to bispectral index indication ( BIS maintained 40-60).
| Study group | Role | What they receive |
|---|---|---|
| Opioid-free anesthesia | Active comparator | Opioid free anesthesia protocol for urological procedurs Receives: Device: OFA |
| Opioid-based anesthesia | Active comparator | Opioid based anesthesia protocol for urological procedures Receives: Drug: OBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Intensity of acute postoperative pain (measured by numeric rating scale NRS 0-10), time frame up to 24h postoperatively
Measured: baseline and 24 hours
Secondary outcomes (1)
postoperative cognitive dysfunction
Change in minimental state evaluation test up to 24 hours postoperatively
Measured: baseline and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Aug 2019
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups of patients assigned to either opioid-free anesthesia or opioid-based anesthesia were studied in a randomized manner as for postoperative pain and cognitive dysfunction
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrysanthi Batistaki, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976842
- Sponsor's protocol ID
- OFA 1
- Status last verified
- Aug 2021
- First submitted
- 10 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Postoperative Pain in Opioid-free Anesthesia After Urological Procedures
- ClinicalTrials.gov ID
- NCT04976842
- Acronym / sponsor ID
- OFA 1
- Keywords
- ANESTHESIA, OPIOIDS, PAIN, COGNITIVE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 26 Jul 2021 (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.
Control of intraoperative and postoperative pain with the use of opioids constitutes normal practice. Opioid free anesthesia (OFA) is a relatively recent anesthesiology practice according to which opioids are not administered during surgery and are avoided postoperatively. Opioid free anesthesia seems to provide better quality of postoperative analgesia while protecting the patient from the side effects of opioids such as respiratory depression, postoperative nausea and vomiting (PONV), opioid induced hyperalgesia and postoperative cognitive dysfunction. The aim of this study is to investigate the possible difference in the intensity of postoperative pain (based on the numeric rating scale 0-10) and the presence of PONV in patients undergoing transurethral urologic surgery under general anesthesia, when patients receive randomly either opioid free anesthesia (OFA) or opioid based anesthesia (OBA).
Detailed description
This study aimed to study postoperative pain after opioid free anesthesia or opioid based anesthesia after urologica; procedures. The two study groups opioid free (OFA) and opioid based (OBA) were as follows:
OFA: Anesthesiology technique based on Mulier protocol. Before induction, loading dose of dexmedetomidine 0,25mcg/kg (max 20mcg). Induction with dexmedetomidine 0,1mcg/kg, lidocaine 1mg/kg, ketamine 0,1mg/kg plus propofol 2mg/kg plus rocuronium1mg/kg IBW (if required). Maintenance with dexmedetomidine 0,1mcg/kg/h, lidocaine 1mg/kg/h, ketamine 0,1mg/kg/h and propofol infusion adjusted according to bispectral index indication ( BIS maintained 40-60). 15 minutes prior to end of surgery, the dose of drugs is reduced to dexmedetomidine 0,05mcg/kg/h, lidocaine 0,5mg/kg/h, ketamine 0,05mg/kg/h.
OBA: Total intravenous anesthesia with propofol for maintenance of anesthesia. Fentanyl 2mcg/kg only at induction and infusion of propofol and remifentanil for maintenance, with doses adjusted according to bispectral index indication ( BIS maintained 40-60).
Both groups receive ranitidine 50mg, dexamethasone 4 mg and paracetamol 1g iv 15 min before the end of surgery. Postoperative analgesia for both groups consists of paracetamol 3g/24h iv, rescue analgesia with tramadol 1mg/kg iv max x3, rescue for PONV ondacetron 4 mg iv.
The outcomes assessed were:
Primary outcome:
- Intensity of acute postoperative pain (NRS 0-10), time frame up to 24h postoperatively
- Nausea and vomiting
Secondary outcome:
- Change in minimental state evaluation test, time frame pre-op, 1h post-op, at discharge
- Severe postoperative adverse effect related to anesthesia (postoperative hypoxemia, ileus, postoperative cognitive dysfunction)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups of patients assigned to either opioid-free anesthesia or opioid-based anesthesia were studied in a randomized manner as for postoperative pain and cognitive dysfunction
| Arm | Type | Receives |
|---|---|---|
| Opioid-free anesthesia | Active comparator | Device: OFAOpioid free anesthesia protocol for urological procedurs |
| Opioid-based anesthesia | Active comparator | Drug: OBAOpioid based anesthesia protocol for urological procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged>18 years old
- ASA I-III
- Patients scheduled for elective transurethral urologic surgery with general anesthesia
Key exclusion criteria (11 listed)
- • Patient refusal
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 |
|---|---|---|
| OFAAnesthesiology technique based on Mulier protocol. Before induction, loading dose of dexmedetomidine 0,25mcg/kg (max 20mcg). Induction with dexmedetomidine 0,1mcg/kg, lidocaine 1mg/kg, ketamine 0,1mg/kg plus propofol 2mg/kg plus rocuronium1mg/kg IBW (if required). Maintenance with dexmedetomidine 0,1mcg/kg/h, lidocaine 1mg/kg/h, ketamine 0,1mg/kg/h and propofol infusion adjusted according to bispectral index indication ( BIS maintained 40-60). 15 minutes prior to end of surgery, the dose of drugs is reduced to dexmedetomidine 0,05mcg/kg/h, lidocaine 0,5mg/kg/h, ketamine 0,05mg/kg/h. | Device | Opioid-free anesthesia |
| OBATotal intravenous anesthesia with propofol for maintenance of anesthesia. Fentanyl 2mcg/kg only at induction and infusion of propofol and remifentanil for maintenance, with doses adjusted according to bispectral index indication ( BIS maintained 40-60). | Drug | Opioid-based anesthesia |
Primary outcome
postoperative pain
Time frame: baseline and 24 hours
Intensity of acute postoperative pain (measured by numeric rating scale NRS 0-10), time frame up to 24h postoperatively
1 secondary outcome
postoperative cognitive dysfunction
Time frame: baseline and 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OFA and OBA in people with Anesthesia and Postoperative Pain, run by Attikon Hospital at 1 site in Greece.
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 11 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 13 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 Greece. 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?
Contact CHRΥSANTHI BATISTAKI, MD, PHD (00302105832371, chrysabatistaki@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: baseline and 24 hours). 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 13 Aug 2021.