- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05936671
EEG and ANI Guided Anesthesia and Quality of Recovery
Quality of Recovery After Electroencephalogram and Nociception Level-guided Versus Standard Anesthesia Care in Female Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Adult women scheduled to undergo laparoscopic gynecologic surgery will be screened for eligibility. Patients will be randomly allocate to either the EEG-and-ANI-guided group or usual care group.
In the guided group, sevoflurane concentration will be titrated according to EEG monitoring. Intraoperative infusion of remifentanil will be titrated by ANI monitoring.
In the usual care group, EEG and ANI sensor will be attached to patients, but EEG and ANI monitor will be blinded to the attending anesthesiologists. The anesthesiologists will provide a standard care of our institution for anesthetic and analgesic titration. In brief, hemodynamic variables and clinical situations will be used to titrate the anesthetic depth and analgesic dose.
Blinded investigator will assess quality of recovery questionnaire-15 at postoperative day 1 and 2.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sun-Kyung Park, MD,PhD
- Phone Number: 821024505924
- Email: mayskpark@gmail.com
Study Locations
-
-
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Seoul, Korea, Republic of
- Not yet recruiting
- Gangnam Severance Hospital
-
Contact:
- Sun-Kyung Park, MD, PhD
- Phone Number: 82-10-2450-5924
- Email: mayskpark@yuhs.ac
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Seoul, Korea, Republic of, 06230
- Recruiting
- GangnamSeverance Hospital
-
Contact:
- Sun-kyung Park
-
Contact:
- Dong Woo Han
- Phone Number: 82-2-2450-5924
- Email: mayskpark@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adult female patients who are scheduled to undergo laparoscopic gynecological surgery.
- Total laparoscopic hysterectomy with/without salpingo-oophorectomy
- Laparoscopic myomectomy
- Laparoscope-guided salpingo-oophorectomy
- Laparoscope-guided ovarian cystectomy
- Laparoscope-guided enucleation of ovarian cyst
Exclusion Criteria:
- Patients with nonregular sinus cardiac rhythm
- Patients with implanted pacemakers
- Patients on antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents
- pregnant or breastfeeding women
- Patients who are unable to communicate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EEG-and-ANI-guided group
During anesthetic maintenance, sevoflurane concentration will be titrated according to EEG monitoring.
Sevoflurane concentration will be titrated to maintain intraoperative Patient state index (PSi) ≥ 35 and to avoid burst suppression.
Intraoperative target-controlled infusion of remifentanil will be titrated to maintain intraoperative ANI between 50 and 70.
|
During anesthetic maintenance, sevoflurane concentration will be titrated according to EEG monitoring.
Sevoflurane concentration will be titrated to maintain intraoperative Patient state index (PSi) ≥ 35 and to avoid burst suppression.
Intraoperative target-controlled infusion of remifentanil will be titrated to maintain intraoperative ANI between 50 and 70.
For anesthetic maintenance, balanced anesthesia with sevoflurane inhalation and target controlled infusion of remifentanil will be performed.
EEG monitoring using SEDline (Masimo, Irvine, California, USA) and Analgesia Nociception Index (ANI; MetroDoloris Medical Systems, Lille, France) monitoring will be performed.
|
Active Comparator: Usual care group
During anesthetic maintenance, the attending anesthesiologists will provide a routine standard care for anesthetic and analgesic titration.
In brief, hemodynamic variables and clinical situations will be used to titrate the sevoflurane concentration and remifentanil infusion rates.
|
For anesthetic maintenance, balanced anesthesia with sevoflurane inhalation and target controlled infusion of remifentanil will be performed.
During anesthetic maintenance, the attending anesthesiologists will provide a routine standard care for anesthetic and analgesic titration.
In brief, hemodynamic variables and clinical situations will be used to titrate the sevoflurane concentration and remifentanil infusion rates.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
15-item Quality of Recovery (QoR-15) at postoperative day (POD) #1
Time Frame: 24 hours after the end of surgery
|
The Korean version of 15-item Quality of Recovery (QoR-15) score.
Each item uses an 11-point numeric rating scale.
The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.
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24 hours after the end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remifentanil consumption during anesthesia
Time Frame: During surgery, from the anesthetic induction to emergence of anesthesia
|
Total remifentanil consumption during anesthesia
|
During surgery, from the anesthetic induction to emergence of anesthesia
|
Occurrence of awareness with recall
Time Frame: During the operation.
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Occurrence of awareness with recall during surgery, which will be asked at postoperative day #1.
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During the operation.
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Incidence of undesirable intraoperative movement
Time Frame: During the operation.
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Incidence of undesirable intraoperative movement during surgery
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During the operation.
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Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)
Time Frame: During the operation
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Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC)
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During the operation
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Intraoperative time ANI <50 [%]
Time Frame: During the operation.
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Intraoperative time of ANI value <50 / total duration of surgery (%)
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During the operation.
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Intraoperative mean PSi
Time Frame: During the operation.
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Intraoperative mean Patient state index (a processed EEG parameter related to a patient's current level of sedation/anesthesia along a scale of 0 to 100, where 100 represents being fully awake)
|
During the operation.
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Intraoperative mean ANI
Time Frame: During the operation.
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Intraoperative mean Analgesia Nociception Index (expressed on a non-unit scale of 0-100; 100 indicates maximal relative parasympathetic tone)
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During the operation.
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Intraoperative EEG burst suppression
Time Frame: During the operation
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Intraoperative occurrence of burst suppression on electroencephalogram
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During the operation
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burst suppression ratio
Time Frame: During the operation
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Intraoperative burst suppression ratio on electroencephalogram
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During the operation
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burst suppression duration
Time Frame: During the operation
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duration of burst suppression on electroencephalogram
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During the operation
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Emergence time
Time Frame: From time of administration of reversal agents of neuromuscular block until time of extubation, assessed up to 2 hours
|
time between reversal of neuromuscular block and extubation
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From time of administration of reversal agents of neuromuscular block until time of extubation, assessed up to 2 hours
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Intraoperative hypotension
Time Frame: During the operation
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Incidence of hypotension during surgery
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During the operation
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Intraoperative phenylephrine consumption
Time Frame: During the operation.
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total dose of phenylephrine consumption during surgery
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During the operation.
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Pain numeric rating scale (NRS)
Time Frame: scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours
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NRS (0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable ") pain scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours
|
scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours
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The incidence of post-operative nausea and vomiting
Time Frame: during the post-anesthesia care unit (PACU) stay, at postoperative day 1, 2
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The incidence of post-operative nausea and vomiting
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during the post-anesthesia care unit (PACU) stay, at postoperative day 1, 2
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Patient satisfaction with anesthetic management
Time Frame: At post-operative 24 hours
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Patient satisfaction with overall anesthetic management in 11-point scale (0-10), The higher the score, the higher the patient's satisfaction.
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At post-operative 24 hours
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Quality of Recovery Questionnaire (15-item Quality of Recovery) at postoperative day #2
Time Frame: At post-operative 48 hours
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Each item uses an 11-point numeric rating scale.
The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.
|
At post-operative 48 hours
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shivering, airway obstruction, respiratory depression, sedation in PACU
Time Frame: from time of the post-anesthesia care unit (PACU) admission to time of discharge from PACU, assessed up to 2 hours
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Incidence of shivering, airway obstruction, respiratory depression, sedation
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from time of the post-anesthesia care unit (PACU) admission to time of discharge from PACU, assessed up to 2 hours
|
Hospital length of stay
Time Frame: From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks
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Hospital length of stay
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From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dong Woo Han, MD,PhD, Gangnam Severance Hospital
Publications and helpful links
General Publications
- Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.
- Upton HD, Ludbrook GL, Wing A, Sleigh JW. Intraoperative "Analgesia Nociception Index"-Guided Fentanyl Administration During Sevoflurane Anesthesia in Lumbar Discectomy and Laminectomy: A Randomized Clinical Trial. Anesth Analg. 2017 Jul;125(1):81-90. doi: 10.1213/ANE.0000000000001984.
- Espitalier F, Idrissi M, Fortier A, Belanger ME, Carrara L, Dakhlallah S, Rivard C, Brulotte V, Zaphiratos V, Loubert C, Godin N, Fortier LP, Verdonck O, Richebe P. "Impact of Nociception Level (NOL) index intraoperative guidance of fentanyl administration on opioid consumption, postoperative pain scores and recovery in patients undergoing gynecological laparoscopic surgery. A randomized controlled trial". J Clin Anesth. 2021 Dec;75:110497. doi: 10.1016/j.jclinane.2021.110497. Epub 2021 Sep 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3-2023-0116
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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