Quality of Recovery After Robotic Surgery

  • STATUS
    Recruiting
  • days left to enroll
    75
  • participants needed
    120
  • sponsor
    Dr Nitin Sethi
Updated on 14 February 2022

Summary

Robotic approach to laparoscopic surgery has greatly facilitated undertaking complex surgery inside the abdominal cavity with ease. Robotic surgery is performed under general anaesthesia (GA), which is commonly administered either via the inhalational route or intravenous route. Currently, there is paucity of evidence regarding comprehensive patient outcome following robotic transabdominal surgery. The limited data that is available is restricted to specific outcome parameters such as hemodynamic profile, recovery times, and concomitant effects (post-operative nausea vomiting, pain). QoR (quality of recovery)-15 is a patient selfreported measurement of outcome to assess postoperative QoR. QoR-15 is a15-item questionnaire that assess physical and mental well-being of the patient after anesthesia and surgery. It is the first validated outcome assessment scale that has been evaluated using the Consensus-based Standards for the Selection of health Measurements Instruments (COSMIN) and fulfils the requirements for assessing QoR postoperatively. We plan to conduct this randomized controlled-trial to evaluate postoperative QoR using the QoR-15 questionnaire in patients undergoing robotic abdominal surgery under GA administered by routine techniques, namely, closed-loop anesthesia delivery system (CLADS) controlled total intravenous anesthesia (TIVA) with propofol or inhalation anesthesia with desflurane.

Description

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.

Details
Condition Patients Undergoing Robotic Surgery
Treatment Propofol, Desflurane
Clinical Study IdentifierNCT03659539
SponsorDr Nitin Sethi
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

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)
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