Impact of Nociceptive-Level (NOL) Intraoperative Guided Analgesia on Pain Scores, Opioid Consumption and Recovery in Postoperative Care Unit in Patients Undergoing Gynecological Laparoscopic Surgery Under General Anesthesia. The NOLGYN Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change of intraoperative IV fentanyl consumption in the Soc+NOL guided group compared to the SoC guided group. Total consumption of fentanyl in mcg.
研究概览
简要总结
The aim of the present study is to show that the use of the NOL device in addition to the Standard of Care (based on mean arterial blood pressure and heart rate values) to guide the administration of opioids compared to the Standard of Care reduces the total fentanyl consumption and the number of intraoperative administration of IV fentanyl during gynecological laparoscopic surgery and improves postoperative outcomes in PACU.
详细描述
Hypothesis: We hypothesize that the group who will be administered intraoperative fentanyl based on NOL + mean arterial blood pressure (MABP) + heart rate (HR) values (SoC+NOL group) versus on MABP and HR (SoC group) will need less intra and postoperative opioid and will report less postoperative pain which will be reflected by a reduced number of adverse effects associated with opioid and/or reduced postoperative pain scores at the PACU arrival resulting in a faster time of readiness to discharge.
Background: The NOL index, a nociception monitor using a multiparametric approach, has shown an excellent sensitivity and specificity in detecting noxious stimuli under general anesthesia. This monitor is better than any other classically used clinical parameter in grading nociception under general anesthesia. More recently, a strong correlation between NOL index response to nociceptive stimulus and the level of opioid analgesia during surgery was reported. Studies are now conducted in our center (Maisonneuve-Rosemont Hospital, University of Montreal, Montreal, QC, Canada) to show a better post-operative outcome when using intraoperative NOL monitoring to adapt nociception/anti-nociception balance during general anesthesia (GA) for colorectal surgery.
So far, no study has evaluated in gynecological laparoscopic surgery the impact of NOL monitoring to guide the administration of intraoperative IV fentanyl on intra and postoperative opioid consumption and pain scores.
Objectives: Primary objective:
Reduction in total intraoperative fentanyl consumption (in mcg) and number of intraoperative administrations of IV fentanyl in the SoC+NOL analgesia guided versus SoC analgesia guided group (SoC = Standard of Care).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Randomization into group SoC + NOL vs SoC will be done prior to the entrance in the OR, the day of the surgery
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age 18-75 years
- •adult patients scheduled to undergo elective gynecological laparoscopic surgery (hysterectomy and uni- or bilateral oophorectomy) under general anesthesia
- •patient able to consent in the language of the including center
排除标准
- •use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia, e.g. transversus abdominal plane block...)
- •patients with non-regular sinus cardiac rhythm, implanted pacemakers, prescirbed antimuscarinic agents, alpha2-adrenergic agonists, beta1-adrenergic antagonists, and antiarrhythmic agents
- •emergent surgery
- •pregnancy/lactation. Pregnancy test will be performed in all women of child bearing age
- •BMI > 35 kg/m2
- •preoperative hemodynamic disturbance
- •central nervous system disorder (neurologic/ head trauma/ uncontrolled epileptic seizures)
- •drug or alcohol abuse within the last 6 months (for women, > 3 drinks on one occasion or >7 drinks during a week)
- •pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks
- •chronic use of psychoactive drugs within 90 days prior to surgery
- •medical conditions qualifying for ASA III or IV:
- •untreated or persistent peripheral or central cardiovascular disease
- •severe pulmonary disease e.g. COPD gold 4, FEV< 1.0l/s, or (evidence of) elevated paCO2 > 6.0 kPa
- •significant hepatic disease with increased bilirubin, INR or low albumin
- •history of severe cardiac arrhythmia e.g. chronic atrial fibrillation
- •active pacemaker or defibrillator
- •allergy or intolerance to any of the study drugs
- •intraoperative cardiac arrhythmia
研究组 & 干预措施
SoC+NOL analgesia guided fentanyl administration
A bolus of 2 mcg/kg of IV Fentanyl will be given at the induction of the anesthesia. A bolus of 1 mcg/kg of IV Fentanyl will be given at the time of incision. During surgery, administration of 0.5 mcg/kg of IV Fentanyl will be administered following a pre determinate algorithm based on NOL index + heart rate + mean arterial blood pressure variations.
Intervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery.
干预措施: Intravenous Fentanyl guided by SoC+NOL (Drug)
SoC analgesia guided group
A bolus of IV Fentanyl at the discretion of a physician will be given at the induction of the anesthesia. A bolus of IV Fentanyl at the discretion of a physician will be given at the time of incision. During surgery, administration of IV Fentanyl at the discretion of a physician will be administred following a pre determinated algorithm based on heart rate + mean arterial blood pressure variations.
Intervention will be here to use Heart rate and blood pressure to administer intraoperative intravenous fentanyl.
干预措施: Intravenous Fentanyl guided by SoC (Drug)
结局指标
主要结局
Change of intraoperative IV fentanyl consumption in the Soc+NOL guided group compared to the SoC guided group. Total consumption of fentanyl in mcg.
时间窗: Intra-operative
Change of intraoperative IV fentanyl consumption in the SoC+NOL guided group compared to the SoC guided group.
Change of frequency of intraoperative IV fentanyl administration in the Soc+NOL guided group compared to the SoC guided group. Frequency is in minutes
时间窗: Intra-operative
Change of frequency of intraoperative IV fentanyl administration in the Soc+NOL guided group compared to the SoC guided group.
次要结局
- Assessment of post operative pain at rest at T45 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10(45 min after PACU entrance)
- Assessment of post operative pain at rest at T30 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10(30 min after PACU entrance)
- Assessment of post operative pain at rest at T0 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10(PACU entrance)
- Assessment of post operative pain at rest at T15 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10(15 min after PACU entrance)
- Assessment of post operative pain at rest at T60 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10(60 min after PACU entrance)
- Assessment of post operative pain at rest at T75 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10(75 min after PACU entrance)
- Assessment of post operative pain at coughing at T0 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.(at PACU entrance)
- Evaluation of intraoperative total vasoactive drugs (diltiazem) consumption in mg(During anesthesia for surgery)
- Evaluation of intraoperative frequency of vasoactive drugs (phenylephrine) administration in number of events(During anesthesia for surgery)
- Evaluation of intraoperative frequency of vasoactive drugs (ephedrine) administration in number of events(During anesthesia for surgery)
- Evaluation of intraoperative frequency of vasoactive drugs (diltiazem) administration in number of events(During anesthesia for surgery)
- Assessment of post operative sedation at T0 minutes in PACU by using Ramsay Sedation Score from 1 to 6(at PACU entrance)
- Assessment of post operative sedation at T15 minutes in PACU by using Ramsay Sedation Score from 1 to 6(15 min after PACU entrance)
- Assessment of post operative sedation at T30 minutes in PACU by using Ramsay Sedation Score from 1 to 6(30 min after PACU entrance)
- Change of post-operative IV hydromorphone consumption. Total consumption of hydromorphone in mcg.(PACU stay (1.5 hours))
- Assessment of post operative pain at rest at T90 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.(90 min after PACU entrance)
- Assessment of post operative pain at coughing at T15 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.(15 min after PACU entrance)
- Assessment of post operative pain at coughing at T30 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.(30 min after PACU entrance)
- Assessment of post operative pain at coughing at T45 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.(45 min after PACU entrance)
- Assessment of post operative pain at coughing at T60 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.(60 min after PACU entrance)
- Assessment of post operative pain at coughing at T75 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.(75 min after PACU entrance)
- Assessment of post operative pain at coughing at T90 minutes in PACU by using Numerical pain rating scales (NPRS) from 0 to 10.(90 min after PACU entrance)
- Evaluation of intraoperative total vasoactive drugs (phenylephrine) consumption in mcg.(During anesthesia for surgery)
- Evaluation of intraoperative total vasoactive drugs (ephedrine) consumption in mcg(During anesthesia for surgery)
- Assessment of post operative sedation at T45 minutes in PACU by using Ramsay Sedation Score from 1 to 6(45 min after PACU entrance)
- Assessment of post operative sedation at T60 minutes in PACU by using Ramsay Sedation Score from 1 to 6(60 min after PACU entrance)
- Assessment of post operative sedation at T75 minutes in PACU by using Ramsay Sedation Score from 1 to 6(75 min after PACU entrance)
- Assessment of post operative sedation at T90 minutes in PACU by using Ramsay Sedation Score from 1 to 6(90 min after PACU entrance)
- Number of nausea episodes in the 24 hours upon discharge from PACU(The 24 hours upon discharge from PACU)
- Number of emetic episodes in the 24 hours upon discharge from PACU(The 24 hours upon discharge from PACU)
- Number of nausea AND vomiting episodes in the 24 hours upon discharge from PACU(The 24 hours upon discharge from PACU)
- Patient self evaluation of nausea intensity(The 24 hours upon emergence)
- Incidence of respiratory depression episodes(1.5 hour since the admission to PACU)
- Incidence of requirement for naloxone reversal of opioids(1.5 hour since the admission to PACU)
- Incidence of requirement for additional reversal of muscle relaxants(1.5 hour since the admission to PACU)
- Assessment of post operative itching at T0 minutes in PACU from 0 to 10(At PACU entrance)
- Assessment of post operative itching at T15 minutes in PACU from 0 to 10(15 min after PACU entrance)
- Assessment of post operative itching at T30 minutes in PACU from 0 to 10(30 min after PACU entrance)
- Assessment of post operative itching at T45 minutes in PACU from 0 to 10(45 min after PACU entrance)
- Assessment of post operative itching at T60 minutes in PACU from 0 to 10(60 min after PACU entrance)
- Assessment of post operative itching at T75 minutes in PACU from 0 to 10(75 min after PACU entrance)
- Assessment of post operative itching at T90 minutes in PACU from 0 to 10(90 min after PACU entrance)
- Post operative time to discharge from PACU in min(PACU stay (1.5 hours))
- Time to the first postoperative pain rescue medication administration in PACU in min(PACU stay (1.5 hours))
- Time to the first postoperative pain rescue medication administration after the PACU discharge(The 24 hours upon discharge from PACU)
研究者
Philippe Richebe
MD PhD, Director of Research
Ciusss de L'Est de l'Île de Montréal