Evaluation of the Impact of Combined Intraoperative Monitoring of Depth of Analgesia, Depth of Anesthesia and Continuous Hemodynamic Data on the Patients Recovery After Cytoreduction Surgery and Hyperthermic Intraperitoneal Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- The hospital length of stay in days
研究概览
简要总结
The objective of our PILOT study is to evaluate the impact of a controlled (monitored) randomized anesthesia during cytoreductive surgery with HIPEC to oxaliplatin in order to treat adenocarcinomas of colorectal origin. The combination of NOL monitoring, BIS monitoring and continuous hemodynamic monitoring (FloTrac EV1000 system) can improve patient safety by reducing the length of hospital stay by decreasing total hypnotic doses and intraoperative opioids and side effects following anesthesia.
详细描述
Title: Evaluation of the combined intraoperative monitoring of depth of analgesia (NOL), depth of anesthesia (BIS) and continuous hemodynamic data (Flotrac EV1000 system) on the patients' recovery after cytoreduction surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). A pilot study.
Hypothesis: Investigators hypothesize that the intraoperative combination of new monitors, NOL index for depth of analgesia, BIS index for depth of anesthesia and Flotrac EV1000 system as continuous hemodynamic monitoring, to guide the delivery of opioids, hypnotics, fluids and inotropes, respectively, will improve the quality of recovery as well as the safety after anesthesia in patients undergoing HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgery.
Background: so far, only vital signs (mostly, blood pressure and heart rate) helped the anesthesiologist to administer hypnotics agents, analgesics, fluids and inotrope. Many devices have offered pain monitoring for anesthetized patients. The NOL index, a nociception monitor using a multiparametric approach, has shown an excellent sensitivity and specificity in detecting noxious stimuli under general anesthesia. More recently, it has been shown a strong inverse correlation between NOL index response to nociceptive stimulus and the increasing doses of opioid analgesia during surgery. Studies on post-operative outcomes when using intraoperative NOL monitoring to adapt nociception/anti-nociception balance during general anesthesia (GA) also reported in our center an improvement of the time to extubation and of the postoperative recovery criteria in PACU after colorectal surgery in the monitored group, leading to a quicker discharge from PACU (presented as an abstract at ASA 2018; manuscript in preparation). Recent studies also showed that avoiding too deep anesthesia by using the BIS index would improve patients' outcome in terms of morbi-mortality. It is also accepted that intra-venous fluid and inotropic/vasopressor drugs have an important effect on intra and postoperative patients' outcomes, in particular following major gastrointestinal surgery. The use of hemodynamic therapy management algorithms has been recommended in a report commissioned by the Centers for Medicare and Medicaid Services in the USA, and by the National Institute for Health and Care Excellence (NICE) in the UK as well as many groups working in ERAS protocols in Canada (and especially Montreal, McGill University) and worldwide.
Based on our recent systematic review (in preparation) and out of the 69 selected published articles, there is no study so far evaluating precisely the impact of anesthesia on postoperative outcomes, and no study combining the NOL, the BIS indexes and the Flotrac EV1000 system to evaluate the impact of a more precise anesthesia management on the postoperative outcomes after cytoreduction and HIPEC for peritoneal carcinomatosis of colorectal origin. Thus, the idea to propose the present study.
Specific Objectives: primary objective: to compare the time to reach the readiness for discharge from hospital and the total postoperative in-hospital length of stay between the Monitored group "M" (optimized, personalized and controlled anesthesia) versus the control group "C" (standard of care anesthesia). Secondary objectives: to evaluate the quality of recovery from anesthesia in the PACU and on the wards and all the adverse events every day and until patient's discharge from hospital. The emergence and extubation time of patients after anesthesia, time spent in PACU (Aldrete score), intra- and postoperative opioid requirements, pain scores (NRS) for several postoperative days, patients' postoperative recovery and satisfaction (the Quality of Recovery: QOR-15, 6min walking test, MOCA, etc.) will be also compared between the 2 groups. Finally, biological outcomes such as blood gas analysis, serum electrolytes, creatinine, DFG, hemoglobin, white blood cell and platelet counts, CRP, serum albumin, INR, PTT will be evaluated on a standard basis in both the groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization into Monitored group "M" (BIS + NOL + Flotrac EV1000) vs control group "C" (standard of care anesthesia) 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA status I, II or III
- •Patients older than 18 years
- •HIPEC for bowel surgery with oxaliplatin + dextrose 5% for a duration of 30 min
- •Duration and type of surgery requiring an epidural analgesia via an epidural catheter placed and tunnelled prior the general anesthesia induction and an arterial line placed after induction of general anesthesia.
排除标准
- •Any allergy to one drug used in our anesthesia or HIPEC protocol
- •Any contra-indication or patient's refusal for epidural placement
- •Chronic arrhythmic cardiac conditions
- •Chronic pain with use of opioids more than 3 times per week for 4 weeks
- •Bowel occlusion
- •Physical/mental incapacities
- •Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
- •Epidural failure
研究组 & 干预措施
Monitored group "M" (optimized controlled anesthesia)
Patients in the Monitored group "M", the NOL index will guide the administration of remifentanil to keep the index between 5-25, and the desflurane will be titrated to keep a BIS index between 45 and 55. Cardiac output and stroke volume variation will be measured by the Flotrac EV1000 system. Patients will receive 250ml fluid challenges with a recommended solution as required, in order to achieve a maximal value of stroke volume.
干预措施: Remifentanil infusion, desflurane titration and fluid infusion will be guided by NOL index, BIS index and Flotrac EV1000 system respectively (Drug)
Control group "C" (standard of care anesthesia)
Patients in the Control group "C" will be managed by clinical staff according to usual practice, desflurane will be administered to keep MAC at 1, and remifentanil infusion rate will be adapted to the mean arterial blood pressure to keep it between 65 and 100.
干预措施: Remifentanil infusion and desflurane titration will be guided by anesthesia usual practices (Drug)
结局指标
主要结局
The hospital length of stay in days
时间窗: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012). After these criteria are achieved, discharge may take place.
Tolerance of oral intake
时间窗: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Tolerance of oral intake. After these criteria are achieved, discharge may take place.
Recovery of lower gastrointestinal function
时间窗: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Recovery of lower gastrointestinal function. After these criteria are achieved, discharge may take place.
Adequate pain control with oral analgesia
时间窗: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Adequate pain control with oral analgesia. After these criteria are achieved, discharge may take place.
Ability to mobilize and self-care
时间窗: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Ability to mobilize and self-care. After these criteria are achieved, discharge may take place.
Clinical examination and laboratory tests show no evidence of complications or untreated medical problems
时间窗: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days
The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: - Clinical examination and laboratory tests show no evidence of complications or untreated medical problems. After these criteria are achieved, discharge may take place.
次要结局
- Intraoperative anesthetic gas' consumption in ml/kg/h(Intraoperative)
- Intraoperative remifentanil consumption in mcg/kg/min(Intraoperative)
- Intraoperative fluid's consumption in ml/h(Intraoperative)
- Intraoperative number of hypotensive events(Intraoperative)
- Intraoperative phenylephrine consumption in mcg/kg/min(Intraoperative)
- Intraoperative epidural consumption in 3 ml/h(Intraoperative)
- Time for awakening in seconds(Intraoperative)
- Time for extubation in seconds(Intraoperative)
- Time for transfert to the PACU in seconds(Intraoperative)
- First NRS pain score (0-10 scale) at times of awakening(Intraoperative)
- First NRS pain score (0-10 scale) at arrival in PACU(Postoperative, evaluated at arrival in PACU)
- NRS pain score (0-10 scale) at rest, in PACU(Postoperative, evaluated every 15 minutes until time for PACU discharge)
- NRS pain score (0-10 scale) with cough, in PACU(Postoperative, evaluated every 15 minutes until time for PACU discharge)
- NRS pain score (0-10 scale) on the Shoulder, in PACU(Postoperative, evaluated every 15 minutes until time for PACU discharge)
- Hydromorphone consumption (mg) in PACU(Postoperative, evaluated every 15 minutes until time for PACU discharge)
- PONV score (0-3 scale) in PACU(Postoperative, evaluated every 15 minutes until time for PACU discharge)
- POSS score (1-4 scale) in PACU(Postoperative, evaluated every 15 minutes until time for PACU discharge)
- Respiratory depression number in PACU(Postoperative, evaluated every 15 minutes until time for PACU discharge)
- Blood pressure (mmHg) in PACU(Postoperative, evaluated every 15 minutes until time for PACU discharge)
- Time for PACU discharge based on Aldrete scores (0-10 scale), in PACU(Postoperative, evaluated every 15 minutes until time for PACU discharge)
- NRS pain score (0-10 scale) at rest, evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- NRS pain score (0-10 scale) with cough, evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- NRS pain score (0-10 scale) on the Shoulder, evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Hydromorphone consumption (mg), evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Epidural consumption (mg), evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- PONV score (0-3 scale), evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- POSS score (1-4 scale), evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Respiratory depression number, evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Blood pressure (mmHg), evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Heart rate (bpm), evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Oxygen saturation (%), evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Respiratory rate (bpm), evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Temperature (°C), evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Overall patient's satisfaction (0-100%), evaluated everyday from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Quality of recovery (QoR-15), evaluated every day from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- 6-minutes walking score, evaluated every day from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- MOCA scores, evaluated every day from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Time for return to food oral intake, evaluated every day from 24 hours postoperative to hospital(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Time for first walking/mobilization, evaluated every day from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Time for first flatus, evaluated every day from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Biological analysis, evaluated every day from 24 hours postoperative to hospital discharge(Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days)
- Rate of hospital readmission and mortality postoperative(Postoperative evaluation, up to 30 days following surgery)
研究者
Philippe Richebe
MD, PhD, Professor, Director of Research, Department of Anesthesiology and Pain Medicine of Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL)
Ciusss de L'Est de l'Île de Montréal