Quality of Recovery After Robotic Surgery
Condition: Patients Undergoing Robotic Surgery
Study type: Interventional

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 self-
      reported 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.
    

Detailed 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.
    

Intervention name(s): PROPOFOL; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 120-patients aged 18-65 years, ASA physical status I/II, of either sex, and undergoing elective major robotic surgery will be randomly allocated to one of the following two groups:
Group-1 [CLADS Group, n=60]: Anaesthesia will be induced and maintained with propofol administered using the BIS feedback-based automated CLADS.
Group-2 [Desflurane Group, n=60]: Anaesthesia will be induced with propofol CLADS and will be maintained intraoperatively by Desflurane titrated to BIS monitoring.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: propofol; desflurane; robotic; recovery