Quality of Recovery After Robotic Surgery
关键词
抽象
描述
The advent of robotic approach to laparoscopic surgery has transformed the practice of transabdominal procedures, especially those involving the pelvic region, such as, prostatectomy, hysterectomy, among others. In-line with the advantages of robotic intervention (greater access and precision), the type of patients who can undergo this surgery has also evolved. Whereas, morbidly obese patients, who were not amenable to 'open' or even 'laparoscopic' approach because of technical difficulties of gaining access to the operative organ/area; can now safely undergo surgery because of high-fidelity and intuitive robotic instrumentation. However, the robotic technique has its own share of concerns: first, it is difficult for the anesthesiologists to access the patient once the robotic arms are docked in position; and second, the extreme positioning (steep Trendelenberg, anti-Trendelenberg position) required to successfully apply the technique may lead to undue burden/adversity on patient's cardiovascular (tachycardia, hypertension, hypotension), respiratory (decreased lung compliance), and central nervous (elevated intracranial pressures) systems.
Therefore, general anesthesia (GA) techniques employed for robotic surgery should be robust and consistent. The common GA techniques, i.e. inhalational or a total intravenous anesthesia (TIVA) can be used. Advantage of inhalation anesthesia is easy titration of the agent by finely calibrated dial concentration control. In addition, the commonly used inhalation anesthetics such as sevoflurane or desflurane rapidly achieve anesthetic brain concentration and the effect can be efficiently reversed quickly upon discontinuation at the end of surgery. TIVA with intravenous anesthetic like propofol is delivered by via simple or target-controlled infusion pumps. Emerging evidence supports the use of propofol TIVA for it may also proffer decreased incidence of postoperative nausea-and-vomiting, anti-inflammatory effect, and anti-neoplastic action.
The evidence on beneficial effect of prolonged robotic surgery on postoperative patient recovery are scanty, unstructured, and limited only to male patients undergoing radical prostatectomy. For the want of a comprehensive patient assessment protocol, the available outcome study has been able to focus on a limited number of parameters, including, changes in intraocular pressure and the incidence of PONV/postoperative pain. Therefore, for knowing the actual outcome effect of GA for robotic surgery, it is essential to analyze elaborate quality-of-recovery from anesthesia based on compendious patients experiences rather than concentrating on specific end-points (hemodynamic profile, recovery time, etc.).
Quality of recovery-15 (QoR-15), a comprehensive patient-reported measure of quality of post-anesthesia, is an abridged form of the expansive 40-item questionnaire (QoR-40) score. QoR-15 assesses both physical and mental well-being of the patient after surgery under GA and is easier to administer. QoR-15 is the first outcome assessment scale which has been evaluated and validated using the consensus-based standards for the selection of health measurements instruments (COSMIN) and fulfils the requirement for being an effective tool for assessment of postoperative recovery/outcome in clinical trials.
Since there is a paucity of evidence on comprehensive post-anesthesia outcome following major robotic procedures and the choice of GA techniques employed for such procedures are subject to random selection; we aim to undertake this randomized-controlled trial to assess postoperative QoR with QoR-15 questionnaire in patients receiving anesthesia either by propofol administration facilitated by automated closed-loop anesthesia delivery system (CLADS) or desflurane inhalation.
日期
最后验证: | 05/31/2019 |
首次提交: | 09/01/2018 |
提交的预估入学人数: | 09/04/2018 |
首次发布: | 09/05/2018 |
上次提交的更新: | 06/28/2019 |
最近更新发布: | 07/01/2019 |
实际学习开始日期: | 09/05/2018 |
预计主要完成日期: | 10/24/2020 |
预计完成日期: | 10/31/2020 |
状况或疾病
干预/治疗
Drug: CLADS group
Drug: Desflurane group
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: CLADS group Anesthesia will be induced with propofol administered using automated closed loop anesthesia delivery system (CLADS) which will be set to deliver Propofol. A BIS-value of 50 will be used as the target for induction of anesthesia. Thereafter anesthesia maintenance will be done with propofol, with its administration controlled with CLADS tuned to consistent anesthetic depth (BIS-50) feedback from the patients. | Drug: CLADS group Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient. |
Active Comparator: Desflurane group Anesthesia will be induced with propofol administered using automated closed loop anesthesia delivery system (CLADS) which will be set to deliver Propofol. A BIS-value of 50 will be used as the target for induction of anesthesia. Thereafter anesthesia maintenance will be done with desflurane using an agent specific vaporiser, whose dial concentration will be adjusted to maintain a BIS of 50-55 in all the patients | Drug: Desflurane group Desflurane delivery will be controlled using a agent specific vaporiser. The dial concentration of the vaporiser will be adjusted to maintain a BIS of 50-55 in the patients. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - ASA physical status I/II - Undergoing elective robotic surgery of more than 60-minutes duration Exclusion Criteria: - Uncompensated cardiovascular illness (uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced left ventricular compliance and diastolic dysfunction) - Pre-existent neurological issues (previous neurosurgical intervention, psychiatric disease, morbid autonomic nervous system: orthostatic hypotension, transient ischemic attacks, history of alcohol/substance abuse, among others) - Hepato-renal insufficiency - Endocrinology problems, e.g. uncontrolled diabetes mellitus, hypothyroidism - Known allergy/hypersensitivity to the study drugs (propofol, desflurane) - Pulmonary dysfunction (chronic restrictive /obstructive lung disease, chronic smokers) - Nutritional ailments: obesity (BMI > 30 kg/m2), malnutrition (severe anaemia [Hb < 8gm%] , hypoalbuminemia [< 3.5gm%], bed-ridden moribund status) |
结果
主要结果指标
1. Quality-of-recovery [From one day before surgery till postoperative day two]
次要成果指标
1. Anaesthesia depth consistency [From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively]
2. Changes in intra-operative heart rate (beats per minute) [From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively]
3. Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg) [From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively]
4. Early recovery [From end of anaesthesia till 20-minutes postoperatively]
5. Early recovery [From end of anaesthesia till 20-minutes postoperatively]
6. Postoperative Sedation [From end of anaesthesia till 24-hours postoperatively]
7. Postoperative Nausea and Vomiting [From end of anaesthesia till 24-hours postoperatively]
8. Postoperative Analgeisa [From end of anaesthesia till 24-hours postoperatively]
9. Intra-operative awareness [From the end of anaesthesia till 48-hours postoperatively]