AnalgesiaNCT05785273
Analgesic Depth Evaluation During General Anesthesia With Dexmedetomidine-remifentanil Infusion. A Pilot Study
An observational study of Analgesia and Anesthesia, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
The aim of this study is to verify the feasibility of an evaluation of the depth of analgesia during an opioid sparing anesthesia (OSA) carried out with continuous infusion of dexmedetomidine in addition to general multimodal anesthesia trough an instrumental pupillary evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Anesthesia
- What is being tested?
- Pupillometer
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 19 Feb 2019to 1 Aug 2019
- Phase
- Observational
- 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
Study population: Patients underwent no-laparoscopic surgery involving at least one surgical incision of more than 5 cm with remifentanil as an intravenous analgesic.
Who may be able to join
- Patients underwent open surgery involving at least one surgical incision of more than 5 cm
- use of remifentanil as an intravenous analgesic.
Who cannot join
- implanted pacemaker or ICD
- ophthalmological comorbidities
- chronic opioid use
- peripheral neuropathy
- continuous infusion of adjuvant drugs other than dexmedetomidine
- epidural analgesia or loco-regional block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Assessment of Analgesic Depth During General Anesthesia With Dexmedetomidine-remifentanil Infusion. A Pilot Study
The aim of this study is to verify the feasibility of an evaluation of the depth of analgesia during an opioid sparing anesthesia (OSA) carried out with continuous infusion of dexmedetomidine in addition to general multimodal anesthesia trough an instrumental pupillary evaluation.
Read the detailed description
In recent years, different strategies have been proposed to reduce opioid use during the perioperative period, i.e., the so-called OFA (opioid free anesthesia) or OSA (opioid sparing anesthesia), in order to reduce some opioid-related side effects with equivalent intraoperative analgesia compared to opioid-based anesthesia.
Dexmedetomidine is a highly selective α2-agonist, with sedative and pain-relieving effects. The use of perioperative dexmedetomidine seems to reduce intraoperative opioid and hypnotic consumption, postoperative pain intensity and postoperative opioid use.
A dexmedetomidine-based protocol for anesthesia in obese patients was introduced in our department towards the end of 2018. All patients undergoing bariatric surgery have been treated with a premedication of dexmedetomidine and a steady infusion of dexmedetomidine as an opioid-savings adjuvant during general anesthesia. In this context, the amount of fentanyl (induction of anesthesia) and remifentanil (maintenance of anesthesia) has been reduced empirically and clinically.
Traditionally, during general anesthesia, the level of nociception is indirectly assessed by observing heart rate, blood pressure and surgical steps. In recent years, new indicators have been proposed to obtain an objective and standardized nociception assessment. Pupillary dilation reflex (PDR) can be related to both painful stimulation and analgesic depth, but not to neuromuscular blockade or hypnotic drug administration. Recently, another rating scale for nociception has been proposed: the PPI (pupillary pain index). This index is based on tetanic stimulation of increasing intensity delivered by two skin electrodes placed on the forearm, evaluating the PDR at each stimulus. A PPI from 1 to 3, from 4 to 6, or from 7 to 9 describes a numbed PDR and deep analgesia, a medium PDR and suboptimal analgesia and a highly reactive PDR and uncontrolled pain, respectively.
The investigators proposal is to study the feasibility of an evaluation of the nociception during an Opioid Sparing Anesthesia (OSA), with continuous infusion of dexmedetomidine and remifentanil, vs "traditional" anesthesia without adjuvant, using the PPI as an indicator of nociception.
- Conditions
- Analgesia, Anesthesia
- Being tested
- Pupillometer
- Keywords
- Dexmedetomidine, Pupil, Nociception, Opioid sparing
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PupillometerDevice
1st pupil evaluation between induction of general anesthesia and onset of surgery. After incision, at least 3 pupil evaluations are performed. Measurements are spaced 15 minutes apart and also taken at least 10 minutes after any variation in drugs dosage
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Patient undergoing general anesthesia receving initial administration of dexmedetomidine loading dose of 0.5-1 μg/kg (ADJUSTED weight) over 15 minutes. After intubation maintenance of general anesthesia is administrated with desflurane or sevoflurane (MAC 0.6 - 1, according to Bispectral Index (BIS) or Patient State Index (Psi)), dexmedetomidine (0.2- 0.4 μg/kg/h (Lean Body Weight)) with constant infusion rate unless hypotension or bradycardia not responsive to standard treatments (filling, atropine, ephedrine, ethylephrine) occurred, and remifentanil (0.02 - 0.2 μg/kg/min (LBW)) based on clinical and instrumental assessment (Heart Rate, Blood Pressure, BIS or Psi). Receives: Device: Pupillometer | |
| No Dexmedetomidine | Patients in this group receive an eventual premedication with benzodiazepines according to anaesthesiologist assessment and patient condition. After intubation general anesthesia is administrated with inhaled (desflurane or sevoflurane; MAC 0.6 - 1) or intravenous (propofol) anesthetics (according to BIS or Psi) and remifentanil (0.02 - 0.2 μg/kg/min (LBW) based on clinical and instrumental assessment (HR, BP, BIS or Psi)). Receives: Device: Pupillometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study protocol
Number of patients enrolled and number of pupillary evaluation during anesthesia
Measured: 6 months
Secondary outcomes (3)
Depth of analgesia
depth of intraoperative analgesia with PPI (pupillary pain index). A PPI from 1 to 3, from 4 to 6, or from 7 to 9 describes a numbed PDR and deep analgesia, a medium PDR and suboptimal analgesia and a highly reactive PDR and uncontrolled pain, respectively.
Measured: Intraoperative
Intra-operative opioid consumption
total consumption of remifentanil (μg/kg/min - Lean Body Weight)
Measured: Intraoperative
Incidence of side effects
incidence of perioperative side effects, PONV and post-operative intolerable pain in the first 24 hours after surgery
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start19 Feb 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Responsible party
- Principal investigator, Martino Stefanini, Università degli Studi di Brescia
- Investigators
- Frank A Rasulo, MD, Study director, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785273
- Sponsor's protocol ID
- UBrescia NP 3675
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grape S, Kirkham KR, Frauenknecht J, Albrecht E. Intra-operative analgesia with remifentanil vs. dexmedetomidine: a systematic review and meta-analysis with trial sequential analysis. Anaesthesia. 2019 Jun;74(6):793-800. doi: 10.1111/anae.14657. Epub 2019 Apr 5.
PubMed 30950522Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.
PubMed 28719527Kim JH, Jwa EK, Choung Y, Yeon HJ, Kim SY, Kim E. Comparison of Pupillometry With Surgical Pleth Index Monitoring on Perioperative Opioid Consumption and Nociception During Propofol-Remifentanil Anesthesia: A Prospective Randomized Controlled Trial. Anesth Analg. 2020 Nov;131(5):1589-1598. doi: 10.1213/ANE.0000000000004958.
PubMed 33079883Stefanini M, Cagnazzi E, Calza S, Latronico N, Rasulo FA. Feasibility of the pupillary pain index as a guide for depth of analgesia during opioid-sparing anesthesia with continuous infusion of dexmedetomidine. J Anesth Analg Crit Care. 2023 Aug 14;3(1):27. doi: 10.1186/s44158-023-00112-8.
PubMed 37580838
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Assessment of Analgesic Depth During General Anesthesia With Dexmedetomidine-remifentanil Infusion. A Pilot Study
- ClinicalTrials.gov ID
- NCT05785273
- Acronym / sponsor ID
- UBrescia NP 3675
- Conditions
- Analgesia, Anesthesia
- Keywords
- Dexmedetomidine, Pupil, Nociception, Opioid sparing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 27 Mar 2023 (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 this study is to verify the feasibility of an evaluation of the depth of analgesia during an opioid sparing anesthesia (OSA) carried out with continuous infusion of dexmedetomidine in addition to general multimodal anesthesia trough an instrumental pupillary evaluation.
Detailed description
In recent years, different strategies have been proposed to reduce opioid use during the perioperative period, i.e., the so-called OFA (opioid free anesthesia) or OSA (opioid sparing anesthesia), in order to reduce some opioid-related side effects with equivalent intraoperative analgesia compared to opioid-based anesthesia.
Dexmedetomidine is a highly selective α2-agonist, with sedative and pain-relieving effects. The use of perioperative dexmedetomidine seems to reduce intraoperative opioid and hypnotic consumption, postoperative pain intensity and postoperative opioid use.
A dexmedetomidine-based protocol for anesthesia in obese patients was introduced in our department towards the end of 2018. All patients undergoing bariatric surgery have been treated with a premedication of dexmedetomidine and a steady infusion of dexmedetomidine as an opioid-savings adjuvant during general anesthesia. In this context, the amount of fentanyl (induction of anesthesia) and remifentanil (maintenance of anesthesia) has been reduced empirically and clinically.
Traditionally, during general anesthesia, the level of nociception is indirectly assessed by observing heart rate, blood pressure and surgical steps. In recent years, new indicators have been proposed to obtain an objective and standardized nociception assessment. Pupillary dilation reflex (PDR) can be related to both painful stimulation and analgesic depth, but not to neuromuscular blockade or hypnotic drug administration. Recently, another rating scale for nociception has been proposed: the PPI (pupillary pain index). This index is based on tetanic stimulation of increasing intensity delivered by two skin electrodes placed on the forearm, evaluating the PDR at each stimulus. A PPI from 1 to 3, from 4 to 6, or from 7 to 9 describes a numbed PDR and deep analgesia, a medium PDR and suboptimal analgesia and a highly reactive PDR and uncontrolled pain, respectively.
The investigators proposal is to study the feasibility of an evaluation of the nociception during an Opioid Sparing Anesthesia (OSA), with continuous infusion of dexmedetomidine and remifentanil, vs "traditional" anesthesia without adjuvant, using the PPI as an indicator of nociception.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | – | Device: PupillometerPatient undergoing general anesthesia receving initial administration of dexmedetomidine loading dose of 0.5-1 μg/kg (ADJUSTED weight) over 15 minutes. After intubation maintenance of general anesthesia is administrated with desflurane or sevoflurane (MAC 0.6 - 1, according to Bispectral Index (BIS) or Patient State Index (Psi)), dexmedetomidine (0.2- 0.4 μg/kg/h (Lean Body Weight)) with constant infusion rate unless hypotension or bradycardia not responsive to standard treatments (filling, atropine, ephedrine, ethylephrine) occurred, and remifentanil (0.02 - 0.2 μg/kg/min (LBW)) based on clinical and instrumental assessment (Heart Rate, Blood Pressure, BIS or Psi). |
| No Dexmedetomidine | – | Device: PupillometerPatients in this group receive an eventual premedication with benzodiazepines according to anaesthesiologist assessment and patient condition. After intubation general anesthesia is administrated with inhaled (desflurane or sevoflurane; MAC 0.6 - 1) or intravenous (propofol) anesthetics (according to BIS or Psi) and remifentanil (0.02 - 0.2 μg/kg/min (LBW) based on clinical and instrumental assessment (HR, BP, BIS or Psi)). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent no-laparoscopic surgery involving at least one surgical incision of more than 5 cm with remifentanil as an intravenous analgesic.
Key inclusion criteria (2 listed)
- Patients underwent open surgery involving at least one surgical incision of more than 5 cm
- use of remifentanil as an intravenous analgesic.
Key exclusion criteria (6 listed)
- implanted pacemaker or ICD
- ophthalmological comorbidities
- chronic opioid use
- peripheral neuropathy
- continuous infusion of adjuvant drugs other than dexmedetomidine
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 |
|---|---|---|
| Pupillometer1st pupil evaluation between induction of general anesthesia and onset of surgery. After incision, at least 3 pupil evaluations are performed. Measurements are spaced 15 minutes apart and also taken at least 10 minutes after any variation in drugs dosage | Device | Dexmedetomidine, No Dexmedetomidine |
Primary outcome
Feasibility of study protocol
Time frame: 6 months
Number of patients enrolled and number of pupillary evaluation during anesthesia
3 secondary outcomes
Depth of analgesia
Time frame: Intraoperative
Intra-operative opioid consumption
Time frame: Intraoperative
Incidence of side effects
Time frame: Intraoperative
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 27 Mar 2023.
- Background: PubMed 30950522Grape S, Kirkham KR, Frauenknecht J, Albrecht E. Intra-operative analgesia with remifentanil vs. dexmedetomidine: a systematic review and meta-analysis with trial sequential analysis. Anaesthesia. 2019 Jun;74(6):793-800. doi: 10.1111/anae.14657. Epub 2019 Apr 5.
- Background: PubMed 28719527Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.
- Background: PubMed 33079883Kim JH, Jwa EK, Choung Y, Yeon HJ, Kim SY, Kim E. Comparison of Pupillometry With Surgical Pleth Index Monitoring on Perioperative Opioid Consumption and Nociception During Propofol-Remifentanil Anesthesia: A Prospective Randomized Controlled Trial. Anesth Analg. 2020 Nov;131(5):1589-1598. doi: 10.1213/ANE.0000000000004958.
- Derived from this study: PubMed 37580838Stefanini M, Cagnazzi E, Calza S, Latronico N, Rasulo FA. Feasibility of the pupillary pain index as a guide for depth of analgesia during opioid-sparing anesthesia with continuous infusion of dexmedetomidine. J Anesth Analg Crit Care. 2023 Aug 14;3(1):27. doi: 10.1186/s44158-023-00112-8.
- 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.
Frank A Rasulo, MD study director
Università degli Studi di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia and Anesthesia, run by Università degli Studi di Brescia at 1 site in Italy.
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 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 27 Mar 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 Italy. 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?
Feasibility of study protocol (time frame: 6 months). 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 NCT05785273, which also lists 4 linked publications.
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 27 Mar 2023.