Laparoscopic Gynecological Surgery
Conditions
Brief summary
This study aims to assess whether electroencephalogram (EEG) and nociception level-guided anesthesia can improve quality of recovery after laparoscopic gynecological surgery compared with standard care. Patients will be randomly assigned to either EEG and Analgesia Nociception Index (ANI)-guided anesthesia group (EEG-and-ANI-Guided group) or usual care group (control group). Primary outcome is 15-item Quality of Recovery (QoR-15) score at postoperative day (POD) 1. Secondary outcomes included remifentanil consumption during anesthesia, occurrence of awareness with recall, incidence of undesirable intraoperative movement, emergence time, postoperative pain scores, quality of recovery score at POD 2, and length of hospital stay.
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.
Interventions
PROCEDUREEEG-and-ANI-guided anesthesia
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.
PROCEDUREstandard anesthesia
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.
DEVICEEEG and ANI
EEG monitoring using SEDline (Masimo, Irvine, California, USA) and Analgesia Nociception Index (ANI; MetroDoloris Medical Systems, Lille, France) monitoring will be performed.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Patients, medical staff who measure outcome variables, surgeons and nurses in the recovery room and wards are blinded so that medical staff and patients do not know the patient's assigned group.
Intervention model description
Prospective, single-blinded, parallel-group, randomized clinical study
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult female patients who are scheduled to undergo laparoscopic gynecological surgery. 1. Total laparoscopic hysterectomy with/without salpingo-oophorectomy 2. Laparoscopic myomectomy 3. Laparoscope-guided salpingo-oophorectomy 4. Laparoscope-guided ovarian cystectomy 5. Laparoscope-guided enucleation of ovarian cyst
Exclusion criteria
1. Patients with nonregular sinus cardiac rhythm 2. Patients with implanted pacemakers 3. Patients on antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents 4. pregnant or breastfeeding women 5. Patients who are unable to communicate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 15-item Quality of Recovery (QoR-15) at postoperative day (POD) #1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of awareness with recall | During the operation. | Occurrence of awareness with recall during surgery, which will be asked at postoperative day #1. |
| Incidence of undesirable intraoperative movement | During the operation. | Incidence of undesirable intraoperative movement during surgery |
| Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC) | During the operation | Intraoperative end-tidal sevoflurane minimum alveolar concentration (MAC) |
| Intraoperative time ANI <50 [%] | During the operation. | Intraoperative time of ANI value \<50 / total duration of surgery (%) |
| Intraoperative mean PSi | During the operation. | 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) |
| Intraoperative mean ANI | During the operation. | Intraoperative mean Analgesia Nociception Index (expressed on a non-unit scale of 0-100; 100 indicates maximal relative parasympathetic tone) |
| Intraoperative EEG burst suppression | During the operation | Intraoperative occurrence of burst suppression on electroencephalogram |
| burst suppression ratio | During the operation | Intraoperative burst suppression ratio on electroencephalogram |
| burst suppression duration | During the operation | duration of burst suppression on electroencephalogram |
| Remifentanil consumption during anesthesia | During surgery, from the anesthetic induction to emergence of anesthesia | Total remifentanil consumption during anesthesia |
| Intraoperative hypotension | During the operation | Incidence of hypotension during surgery |
| Intraoperative phenylephrine consumption | During the operation. | total dose of phenylephrine consumption during surgery |
| Pain numeric rating scale (NRS) | scores during post-anesthesia care unit (PACU) stay, at postoperative 24, 48 hours | 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 |
| The incidence of post-operative nausea and vomiting | during the post-anesthesia care unit (PACU) stay, at postoperative day 1, 2 | The incidence of post-operative nausea and vomiting |
| Patient satisfaction with anesthetic management | At post-operative 24 hours | Patient satisfaction with overall anesthetic management in 11-point scale (0-10), The higher the score, the higher the patient's satisfaction. |
| Quality of Recovery Questionnaire (15-item Quality of Recovery) at postoperative day #2 | At post-operative 48 hours | 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. |
| shivering, airway obstruction, respiratory depression, sedation in PACU | from time of the post-anesthesia care unit (PACU) admission to time of discharge from PACU, assessed up to 2 hours | Incidence of shivering, airway obstruction, respiratory depression, sedation |
| Hospital length of stay | From date of hospital admission until the date of hospital discharge, assessed up to 100 weeks | Hospital length of stay |
| Emergence time | 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 |
Countries
South Korea
Contacts
Primary ContactSun-Kyung Park, MD,PhD
Outcome results
None listed