Scheduled Laparoscopic SurgeryNCT02116868
Pupillary Reflex Measurement to Guide Intraoperative Analgesia During Laparoscopic Surgery
A study testing Pupillometry guided analgesia (PP) and Tailored antihypertensive drug administration in people with Scheduled Laparoscopic Surgery, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
The purpose of this study is to determine whether analgesia guided by pupillary reflex during laparoscopic surgery is effective in opioid sparing (intraoperative remifentanil and postoperative morphine).This is a prospective, randomized, controlled study performed in two centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scheduled Laparoscopic Surgery
- What is being tested?
- Pupillometry guided analgesia (PP) and Tailored antihypertensive drug administration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2014to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists status 1 to 4
- Scheduled laparoscopic surgery
- Standardized anesthesia (TCI)
- Social security affiliation
Who cannot join
- Age < 18 yrs old
- Emergency
- BMI ≥ 35 kg.m-2
- Refusal of consent
- History of ocular pathology
- Intake of: metoclopramide, droperidol, opioids or substitutive therapies
Show all 10Show fewer
- Patient with chronic pain
- Neurologic impairments
- Neuropathic pain
- Drug or alcohol abuse
Trial locations and contacts
2 sites in 1 country.
France2 sites
Maternité Régionale Universitaire (MRU)
Nancy, Lorraine, 54000
Centre Hospitalier Universitaire, Brabois
Nancy, Lorraine, 54500
About this study
Official title: Usefulness of Pupillary Reflex on Remifentanil and Morphine Consumption During Laparoscopic Surgery. A Bicentric, Prospective, Randomized, Controlled Trial.
The purpose of this study is to determine whether analgesia guided by pupillary reflex during laparoscopic surgery is effective in opioid sparing (intraoperative remifentanil and postoperative morphine).This is a prospective, randomized, controlled study performed in two centers.
Read the detailed description
For now, intraoperative analgesia remains hard to assess in the absence of reliable and validated analgesia monitor. The analysis of pupillary reflex is a new tool to assess analgesia during the intraoperative and postoperative period.
During laparoscopic surgery, carbon dioxide insufflation that produce pneumoperitoneum may induce hemodynamics events such as tachycardia or hypertension. These events may be misleading or confusing. Actually, these events are mainly considered as insufficient analgesia. Thus, anesthesiologists deepen analgesia and/or anesthesia by increasing concentration of anesthetics or opioids. These inappropriate actions may induce hypotension and/or bradycardia especially in elderly patients. On the contrary, insufficient analgesia may exist in hypovolemic patients or in patients with neuromuscular blocking agents.
- Conditions
- Scheduled Laparoscopic Surgery
- Being tested
- Pupillometry guided analgesia (PP), Tailored remifentanil controlled infusion, Tailored antihypertensive drug administration
- Keywords
- Pupillometry, Pupillary reflex, Analgesia, Laparoscopic surgery, Total intravenous anesthesia, Target controlled infusion
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupillometry guided analgesia (PP)Device
Also called Algiscan Neurolight, Pupillometer
Analgesia is guided by pupillary reflex provided by the pupillometer (AlgiScan). The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed (Tailored remifentanil controlled infusion). Administration of antihypertensive drugs or vasopressors is also guided.
Tailored remifentanil controlled infusionDrug
Also called Traget controlled infusion, TCI
The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed
Tailored antihypertensive drug administrationDrug
Also called Esmolol, Nicardipine, Urapidil
Administration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex.
| Study group | Role | What they receive |
|---|---|---|
| Pupillometry guided analgesia (PP) | Experimental | Analgesia is guided by pupillary reflex. The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed. Administration of antihypertensive drugs or vasopressors is also guided. Receives: Device: Pupillometry guided analgesia (PP); Drug: Tailored remifentanil controlled infusion; Drug: Tailored antihypertensive drug administration |
| Standard practice (ST) | No intervention | Anesthesia and analgesia is left to the discretion of the anesthesiologist in charge. The anesthesiologist is blinded to the results of pupillometry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroperative Remifentanil consumption
Measured: From the start of anesthesia to the end of surgery (<10 hours)
Secondary outcomes (8)
Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...)
Measured: From the start of anesthesia to the end of surgery (<10 hours)
Use of antihypertensive agents or vasopressors
Measured: From the start of anesthesia to the end of surgery (<10 hours)
Volume of fluid replacement
Measured: From the start of anesthesia to the end of surgery (<10 hours)
Pain scores
Using verbal rating scale
Measured: In the immediate postoperative period (<4 hours)
Incidence of postoperative nausea and vomiting (PONV)
Measured: In the immediate postoperative period (<4 hours)
Time from extubation between the end of surgery and PACU admission
Measured: In the immediate postoperative period (<4 hours)
Length of stay in PACU
Measured: From PACU admission to an ALDRETE score of 10 (< 4 hours)
Immediate postoperative morphine consumption
Measured: During postanesthetic care unit (PACU) stay (<4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2018
- Study completionApr 2018
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 Scheduled Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude MEISTELMAN, MD., PhD., Study chair, Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCEPhilippe GUERCI, MD, Principal investigator, Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCEFlorence VIAL, MD, Principal investigator, Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, FranceHervé BOUAZIZ, MD., PhD., Study chair, Department of Anesthesiology, Maternité Regionale Universitaire, CHU NANCY, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116868
- Sponsor's protocol ID
- 2013-A01002-43
- Status last verified
- Oct 2019
- First submitted
- 10 Apr 2014
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Guerci P, Jay G, Arnout C, Herbain D, Baka N, Poirel O, Novy E, Bouaziz H, Vial F. Effects of pupillary reflex dilation-guided opioid administration on remifentanil and morphine consumption during laparoscopic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2021 Sep 1;38(9):975-984. doi: 10.1097/EJA.0000000000001491.
PubMed 33913678
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Pupillary Reflex on Remifentanil and Morphine Consumption During Laparoscopic Surgery. A Bicentric, Prospective, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02116868
- Acronym / sponsor ID
- 2013-A01002-43
- Conditions
- Scheduled Laparoscopic Surgery
- Keywords
- Pupillometry, Pupillary reflex, Analgesia, Laparoscopic surgery, Total intravenous anesthesia, Target controlled infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 17 Apr 2014 (estimated)
- 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 determine whether analgesia guided by pupillary reflex during laparoscopic surgery is effective in opioid sparing (intraoperative remifentanil and postoperative morphine).This is a prospective, randomized, controlled study performed in two centers.
Detailed description
For now, intraoperative analgesia remains hard to assess in the absence of reliable and validated analgesia monitor. The analysis of pupillary reflex is a new tool to assess analgesia during the intraoperative and postoperative period.
During laparoscopic surgery, carbon dioxide insufflation that produce pneumoperitoneum may induce hemodynamics events such as tachycardia or hypertension. These events may be misleading or confusing. Actually, these events are mainly considered as insufficient analgesia. Thus, anesthesiologists deepen analgesia and/or anesthesia by increasing concentration of anesthetics or opioids. These inappropriate actions may induce hypotension and/or bradycardia especially in elderly patients. On the contrary, insufficient analgesia may exist in hypovolemic patients or in patients with neuromuscular blocking agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pupillometry guided analgesia (PP) | Experimental | Device: Pupillometry guided analgesia (PP), Drug: Tailored remifentanil controlled infusion, Drug: Tailored antihypertensive drug administrationAnalgesia is guided by pupillary reflex. The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed. Administration of antihypertensive drugs or vasopressors is also guided. |
| Standard practice (ST) | No intervention | –Anesthesia and analgesia is left to the discretion of the anesthesiologist in charge. The anesthesiologist is blinded to the results of pupillometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists status 1 to 4
- Scheduled laparoscopic surgery
- Standardized anesthesia (TCI)
- Social security affiliation
Key exclusion criteria (10 listed)
- Age < 18 yrs old
- Emergency
- BMI ≥ 35 kg.m-2
- Refusal of consent
- History of ocular pathology
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 |
|---|---|---|
| Pupillometry guided analgesia (PP)Also: Algiscan Neurolight, PupillometerAnalgesia is guided by pupillary reflex provided by the pupillometer (AlgiScan). The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed (Tailored remifentanil controlled infusion). Administration of antihypertensive drugs or vasopressors is also guided. | Device | Pupillometry guided analgesia (PP) |
| Tailored remifentanil controlled infusionAlso: Traget controlled infusion, TCIThe anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed | Drug | Pupillometry guided analgesia (PP) |
| Tailored antihypertensive drug administrationAlso: Esmolol, Nicardipine, UrapidilAdministration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex. | Drug | Pupillometry guided analgesia (PP) |
Primary outcome
Peroperative Remifentanil consumption
Time frame: From the start of anesthesia to the end of surgery (<10 hours)
8 secondary outcomes
Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...)
Time frame: From the start of anesthesia to the end of surgery (<10 hours)
Use of antihypertensive agents or vasopressors
Time frame: From the start of anesthesia to the end of surgery (<10 hours)
Volume of fluid replacement
Time frame: From the start of anesthesia to the end of surgery (<10 hours)
Pain scores
Time frame: In the immediate postoperative period (<4 hours)
Incidence of postoperative nausea and vomiting (PONV)
Time frame: In the immediate postoperative period (<4 hours)
Time from extubation between the end of surgery and PACU admission
Time frame: In the immediate postoperative period (<4 hours)
Length of stay in PACU
Time frame: From PACU admission to an ALDRETE score of 10 (< 4 hours)
Immediate postoperative morphine consumption
Time frame: During postanesthetic care unit (PACU) stay (<4 hours)
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 1 Nov 2019.
- Derived from this study: PubMed 33913678Guerci P, Jay G, Arnout C, Herbain D, Baka N, Poirel O, Novy E, Bouaziz H, Vial F. Effects of pupillary reflex dilation-guided opioid administration on remifentanil and morphine consumption during laparoscopic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2021 Sep 1;38(9):975-984. doi: 10.1097/EJA.0000000000001491.
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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.
Claude MEISTELMAN, MD., PhD. study chair
Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
Philippe GUERCI, MD principal investigator
Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
Florence VIAL, MD principal investigator
Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pupillometry guided analgesia (PP) and Tailored antihypertensive drug administration in people with Scheduled Laparoscopic Surgery, run by Central Hospital, Nancy, France at 2 sites in France.
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 10 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Peroperative Remifentanil consumption (time frame: From the start of anesthesia to the end of surgery (<10 hours)). 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 NCT02116868, 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 1 Nov 2019.